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last updated: 2026-03-10_105742
file_name: _archive-combined-files_fl-proposals_35k.md
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CONTENT
# _archive-combined-files_fl-proposals_35k (7 files, 34,835 tokens)
# 1,571 _context-commentary_various-fl-proposals.md
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last updated: 2026-02-20 RT
file_name: _context-commentary_various-fl-proposals_WIP.md
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CONTENT
## Context
This subcategory contains six proposal-related documents spanning FloodLAMP's funding and partnership efforts from 2020 to 2022:
- **RADx 2020 Submitted Proposal** (August 2020, ~$1M requested, not funded): An early-pandemic proposal for a mass screening program using extraction-free colorimetric LAMP with flexible pooling and distributed deployment.
- **RADx 2022 Solicitation** (October 2022): The NIH/NIBIB solicitation for high-performance COVID-19 rapid tests under which FloodLAMP applied.
- **RADx 2022 Submitted Proposal** (October 2022, $3M requested, not funded): A proposal for a next-generation LAMP-based platform with reagent-in-cap test devices, modular instruments, and integrated digital tools.
- **Balvi Proposal 1** (November 2022, $3M requested, not funded): A comprehensive plan for open-source platform publication, clinical studies, regulatory submissions, manufacturing, and governance.
- **Balvi Proposal 2** (December 2022, $300K requested, funded): A reduced-scope plan focusing on open-sourcing program materials, publishing pilot data, and clinical study groundwork.
- **Florida State EMS Proposal** (January 2022, ~$5.3M total for Phases 1-2, did not proceed): A phased plan for statewide deployment of FloodLAMP surveillance testing at EMS agencies.
These proposals document FloodLAMP's evolving strategy over the company's three-year operating period, from early pandemic mass-screening concepts through next-generation device development and open-source business models. They also serve as a record of the funding landscape and partnership dynamics facing a small pandemic diagnostics company during this period.
FloodLAMP Biotechnologies was incorporated in Delaware as a Public Benefit Corporation (PBC) in August 2020, having spun out from a 501(c)(3) STEM education nonprofit. A PBC is a for-profit C corporation with one additional legal feature: enhanced protections for the board of directors when making decisions that support the company's stated public benefit mission, even if those decisions are not in shareholder financial interest. This corporate structure is relevant to broader governance discussions, as several major technology and AI companies have are PBC's.
The company was primarily funded by investments - approximately $1.5M over the three years of operation (summer 2020 through 2023), with the majority ($1M) from founder, Randy True, and $500,000 from angels, all structured as convertible notes. FloodLAMP made ~$250K in revenue from selling systems, kits, and testing services to the pilot programs. Additionally, FloodLAMP received a $300K grant from the open source COVID relief fund BALVI in 2023.
During operations, major expenses included a primer order from LGC BioSearch Technologies of approximately $90,000 for 1.2 million reactions (of which roughly 100,000 were manufactured and approximately 20,000 shipped to customers), laboratory space at approximately $20,000 per month, staffing and salaries, and regulatory consulting. FloodLAMP performed the majority of its regulatory drafting work internally, drawing on examples from collaborators.
FloodLAMP filed patents (see the fl-patent subcategory) but committed to open source through its March 2021 FDA submissions, which included a blanket right of reference to primer validation data (see fl-fda-correspondence and open-euas subcategories under Regulatory). The primers used in FloodLAMP's tests, including the high-performing AS1E set developed in Connie Cepko's lab at Harvard, were subject to the university's standard IP ownership agreement. Harvard provided no-royalty licenses for an initial period, but extended negotiations with the licensing department were never completed. This experience is relevant to discussions about how university IP policies can affect the availability of critical reagents during a public health emergency.
## Commentary
#### RADx
*Work in progress. Detailed RADx commentary is being developed separately. See: data/floodlamp/various/external-programs-reports/RADx Program Overview - NIH Rapid Acceleration of Diagnostics.md*
FloodLAMP submitted two proposals to the NIH RADx program. The first was an August 2020 application for approximately $1M, submitted through the nonprofit Focus on Foundations before FloodLAMP's incorporation as a PBC. It proposed an immediately scalable mass screening program using extraction-free colorimetric LAMP with flexible pooling and distributed deployment. The second, submitted in October 2022 under the RADx Tech III solicitation for high-performance testing, requested $3M for a next-generation platform with reagent-in-cap test devices, modular heater/reader instruments, and integrated digital tools, building on lessons from 11 surveillance deployments. Neither was funded.
#### Florida State
The "Resilient Florida" proposal (January 2022) outlined a phased plan to deploy FloodLAMP's surveillance testing system at EMS departments across the state, starting with 10 sites in Phase 1 (~$966K) and expanding to 50 sites plus mobile capability in Phase 2 (~$4.36M). The proposal grew out of FloodLAMP's relationship with a medical director in South Florida who was instrumental in establishing the two largest pilot sites (Coral Springs and Davie) and was the primary connection point for most of FloodLAMP's EMS pilot deployments and business revenue (see the Pilots category for details on individual sites).
The state-level opportunity appeared highly promising. FloodLAMP's medical director communicated that the state EMS medical director was very interested in a statewide deployment, with messaging that framed the question as how to implement rather than whether to proceed. Within days of booking travel to meet with state leadership, the interest appeared to evaporate. The meeting never materialized. Governor DeSantis made COVID-related announcements during this same period, though the specific factors behind the reversal were not communicated to FloodLAMP.
This coincided with the early 2022 Omicron wave. The variant's rapid spread, combined with a growing consensus that it was less virulent than earlier strains, appeared to sharply reduce institutional urgency around COVID testing broadly. FloodLAMP experienced this shift acutely.
During the same trip, FloodLAMP explored expansion in South Florida, establishing a presence at an accelerator and innovation center at NOVA University. However, the declining trajectory of interest in COVID screening made expansion untenable. The Florida State proposal remains in the archive as a detailed record of how FloodLAMP envisioned scaling its model: turnkey equipment packages, locally trained technicians, weekly kit resupply, and a plug-and-play primer architecture designed to be repurposed for future pathogens.
#### Balvi
FloodLAMP learned about Balvi through the director of Abrome, a school in Austin, TX that was already operating FloodLAMP's COVID screening system with Balvi funding (~$30K). Balvi was a COVID-response funding initiative supported by approximately $100 million from Ethereum co-founder Vitalik Buterin's 2021 pandemic relief donation.
Two proposals were submitted. The first (November 2022) requested approximately $3 million for a comprehensive plan covering open-source platform publication, clinical studies, regulatory submissions, manufacturing scale-up, and corporate governance work. Balvi indicated it could not support that level and asked FloodLAMP to consider a smaller amount. The second (December 2022) requested $300,000, focusing on open-sourcing program materials, publishing pilot data, and groundwork for clinical studies. This second grant was approved and is the funding under which the current archive and publication work is being completed.
# 4,905 Balvi Proposal 1 - FloodLAMP Decentralized COVID Screening (Nov 2022 - 3M - Not Funded).md
METADATA
last updated: 2026-03-06 by BA
file_name: Balvi Proposal 1 - FloodLAMP Decentralized COVID Screening (Nov 2022 - 3M - Not Funded).md
file_date: 2022-11-19
title: Balvi Proposal 1 - FloodLAMP Decentralized COVID Screening (Nov 2022 - 3M - Not Funded)
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conversion: pandoc
license: CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/
tokens: 4905
words: 2934
notes: has html table instead of pipe md for deliverables
summary_short: The FloodLAMP Balvi Proposal (Balvi ID B57, Nov. 19, 2022) outlines a plan to build open-source, decentralized infectious disease screening using low-cost extraction-free LAMP testing, self-pooled swab collection, and supporting software, arguing that decentralization, openness, and sub-$5 pricing are essential for pandemic preparedness. It summarizes FloodLAMP’s pilot deployments and partnerships (e.g., NEB and SalivaDirect) and proposes deliverables spanning open program dissemination, publication of pilot data, expanded surveillance deployments, clinical studies and open-protocol FDA submissions, manufacturing scale-up, and legal/governance work. It also provides company background, funding needs and budget, and a growth strategy emphasizing open regulatory pathways, scalable manufacturing, and potential licensing/governance models to sustain public-benefit operations.
CONTENT
***INTERNAL TITLE:*** FloodLAMP: open source decentralized infectious disease screening.
Balvi ID: B57
Balvi Proposal - Nov. 19, 2022
FloodLAMP Biotechnologies, PBC
Randy True randy@floodlamp.bio
We think that the best, and perhaps only, way to have stopped the spread of the SARS-CoV-2 virus was with early, broad based testing. The U.S. and the other countries (with the exception of China) still lack the capability to carry out large scale disease screening. As a result, we remain vulnerable to variants and even more worrying, to new, more deadly pathogens. Mass testing should be a cornerstone of pandemic preparedness and response, but many complex, interconnected problems need to be overcome in order to achieve this important capability.
FloodLAMP Biotechnologies is a Public Benefit Corporation solely focused on solving these problems and helping to deliver universally accessible pandemic response screening. Our assumptions are:
1. **Decentralization** is needed – the central lab model failed in the U.S. during the COVID-19 pandemic. Anyone or any organization needs to be able to purchase and run testing, with no or very streamlined oversight.
2. **Isothermal molecular** will win – for mass testing programs over antigen, due to better accuracy and flexibility. Molecular is quicker to adapt to new targets and more efficient for groups running point-of-need testing. Isothermal (LAMP) has revolutionary potential but so far the commercial focus is on expensive, single use/one-at-a-time devices. Further developing LAMP modalities can unlock the entire space.
3. **Cost** must be low – $5 or less per sample, ideally down to $1 (achievable now with self-pooling).
4. **Open** is needed – the molecular diagnostics industry’s standard business model is siloed, proprietary technology and 80-90% margins. A new paradigm of “open source protocol” FDA approvals that fully disclose chemistry and primer sequences can have huge impact due to global regulatory harmonization.
5. **Integrated innovation** is needed – achieving mass scale at low cost will require progress on policy, technology, programs, and business models – all planned and executed to work together.
Over the last year and a half, we have completed 11 pilot screening programs that are affordable, locally controlled, and can be scaled in a decentralized manner. We have considered not only assay chemistry but also operational configurations, enabling software, and regulatory pathways. The programs use what we consider to be the best current technology stack: isothermal molecular amplification ([LAMP using NEB Master Mix](https://www.neb.com/applications/dna-amplification-pcr-and-qpcr/isothermal-amplification/loop-mediated-isothermal-amplification-lamp)), extraction-free assay chemistry ([Rabe-Cepko protocol](https://www.pnas.org/doi/10.1073/pnas.2011221117)), and self-pooled swabs. In the majority of these pilots, we provided turn-key, in-house programs that included all of the physical materials, digital tools, training and support, with the partner organizations providing the space and staffing. The largest programs were ~1,000 person municipal workforces in two cities in Florida, run by the Emergency Medical Services departments. They scaled to thousands of samples per week during the Omicron surge, screening all first responders regularly. Both cities made our program mandatory despite having access to PCR testing services and practically unlimited antigen tests. We also have deployed successful school pilots that have used our novel at-home self-pooled sample collection, including Abrome in Austin, TX which received Balvi funding.
We are seeking funding from Balvi to publish our work, expand upon our current programs, and at the same time build the foundation for an enduring entity to help achieve universal access to disease testing, first for all known pandemic-threat pathogens, and then more broadly for improving global health. Key progress on the program and policy fronts can be made, especially with respect to open source FDA approvals and clarity on non-diagnostic testing regulations. On the technical front, our plans include developing a next generation rapid molecular OTC, POC/PON platform (for which we have filed IP and applied for [RADx funding](https://www.poctrn.org/web/radx-tech-high-performance-tests)). There is significant overlap between further developing our current platform and the next gen one, such as bridge assay development work. Please see our [RADx submission](https://docs.google.com/document/d/1dd6XmU5FCCjMfFILdclqgM5yZABerFXfbSB5iPNmSBw/edit?usp=sharing) for details about this as well as information about our pilots, test performance, regulatory filings, and technology development plans.
The following is the set of deliverables we propose. The majority of these have a great deal of groundwork already laid and can proceed in parallel. The timing on several (#3 Expand surveillance programs, \#5 Manufacturing scale up) depend upon the trajectory of the pandemic this winter, and subsequent demand/need for COVID screening. Interest and funding from federal agencies, such as RADx, would also have an impact on priorities and timing.
## Deliverables
| Deliverables | Impact | Estimated Timeline |
|---|---|---|
| **1. Open source programs**
1A. Website openly disseminating all program information, guides, and supporting docs.
1B. Support for multiple profiles and scales.
1C. Web app version of mobile app. | • Enablement of orgs seeking to bring up locally controlled testing.
• Initiates broad-based feedback.
• Demonstrates new open, cooperative approach. | 1A. 4-10 weeks
1B. 8 weeks (beta)
1C. 16 weeks |
| **2. Publication**
2A. Publish data from 11 pilots programs using LAMP-based COVID surveillance.
2B. Preprint + submission to open access peer reviewed journal.
2C. Website update and outreach when preprint goes live. | • Opens avenues to obtain help and further funding from PPR allies.
• Gets attention of U.S. federal agencies (CDC, ASPR, NSC, OSTP).
• Establishes company credibility.
• PR opportunity.
• Stimulates consideration of mass testing for PPR in U.S. | 4 weeks |
| **3. Expand surveillance programs**
3A. 20+ additional deployments in prioritized populations (EMS, Schools)
3B. Consider commercial operations for high profit programs (Entertainment)
3C. Additional targets (influenza, RSV) | • Reduces disease burden in target populations.
• Progress on legal and procedures for non-diagnostic testing.
• Pushes on FDA/CMS boundaries to legitimize public health emergency/pandemic testing. | 30 weeks |
| **4. Clinical studies and FDA EUA submissions**
4A. Clinical studies to gather data needed to support FDA EUA submissions.
4B. EUA submissions as open source protocol tests.
4C. Multi-site studies to support 510K. | • Key step to obtaining OS EUA, which
○ establishes new OS paradigm for IVD diagnostics at FDA;
○ enables global dissemination.
• Proves out new powerful study design that combines non-dx, organization based screening. | 12 weeks |
| **5. Manufacturing scale up**
5A. Manufacture reagents for 450K test kits.
5B. Purchase consumables & collection kits.
5C. Engagement with contract manufacturers. | • Derisks continued operations.
• Gives internal capacity for scaling programs in different configurations.
• Sets stage for growth of manufacturing capabilities. | 8 weeks |
| **6. Legal agreements and plan for growth**
6A. Standard licenses
6B. Corporate structure changes, to establish FloodLAMP's creation of public goods and simultaneously support growth | • Provides foundation for the next stage of the company/new entity.
• Serves as an example of implementation of key governance, commercial, and IP issues for public goods focused entities. | 6 weeks |
||
## Budget
The budget below is a breakdown of spending to meet the proposed deliverables. A second budget for a set of supplementals includes areas for which we are also seeking funding from RADx. We included a placeholder line item for commercial operations, which we can discuss in the context of the main proposal and Balvi priorities.
[Balvi Proposal 1 - Budget](https://docs.google.com/spreadsheets/d/1QUWxjItRY1k-QHd1DmSPnTbUJQ8SyT5Qfxmqh3FHFjg)
### Budget 11-17
| $730,000 | Open Source Platform |
|----------|------------------------------------------------------------------------|
| $250,000 | OS Platform - new CYOA website |
| | $200,000 Web agency - design and dev |
| | $50,000 Studio & Video production |
| $80,000 | Legal IP - open license w commercial terms (app and test) |
| $200,000 | Comms - Publication, Outreach, Community, PR, Summit, Interview Series |
| $200,000 | Web App w open license Non-Comm, Non-govt |
||
| $450,000 | Clinical and Regulatory | |
|----------|------------------------------------------------------------|--|
| $200,000 | 50K Test Kits for Clinical Studies w Surveillance ($4/kit) | |
| $100,000 | Regulatory Consulting (Arete, SalivaDirect partnership) | |
| $150,000 | Clinical Studies Site Bring Up & Maintenance (5 x $30K) |
||
| $590,000 | Manufacturing Scale Up |
|----------|--------------------------------------------------------------------|
| $300,000 | 400K Test Kits (excluding NEB MM ~$550K) |
| $90,000 | Remaining LGC Primers (800K reactions) |
| $200,000 | Contract Manufacturing (uncertain estimate for initial engagement) |
||
| $1,320,000 | Staff | 8 | heads | 80% | ramp |
|------------|--------------------|----------|-------------|-----|------|
| $788,800 | Employee Salaries | $116,000 | salaries/mo | 7 | mo |
| $177,480 | Benefits and Taxes | 22.5% | overhead | | |
| $350,000 | Contractor Fees | $50,000 | fees/mo | 7 | mo |
||
| $60,000 | Equipment (Internal) |
|---------|----------------------|
| $60,000 | PCR Machines |
||
| $3,150,000 | TOTAL PROPOSAL |
|------------|----------------|
| $1,210,000 | Next Gen Platform R&D |
|------------|-----------------------------------------------|
| $200,000 | Device Prototype Fabrication |
| $350,000 | Instrument Prototype |
| $660,000 | Next Gen Staff: 3 FTE for 6 mo, 4 contractors |
||
| $220,000 | Assay R&D and Test Improvement |
|----------|--------------------------------|
| $100,000 | Assay Dev Scientist (6 mo) |
| $50,000 | NEB lyo development |
| $50,000 | Inactivation Solution Tubing |
| $20,000 | Droppers |
||
| $100,000 | Commercial Team Seed Funds |
|----------|----------------------------|
| $1,530,000 | TOTAL SUPPLEMENTALS |
|------------|---------------------|
## FloodLAMP Company Information
FloodLAMP Biotechnologies was incorporated in Delaware on 8/3/2020 as a Public Benefit Corporation. Our charter states “the specific public benefit that the Corporation will promote is the development of open protocols and the implementation of large scale disease screening for infectious disease for the benefit of the public.”
We are currently 4 employees, 2 full time and 2 part time. Please see the last portion of our recent [RADx funding submission](https://docs.google.com/document/d/1dd6XmU5FCCjMfFILdclqgM5yZABerFXfbSB5iPNmSBw/edit?usp=sharing) for profiles of our team members. Here is a more detailed bio for our CEO and founder, Randy: [Randall True Biosketch](https://drive.google.com/file/d/1hgpfBA99cNOszNrRA9Ft4FFdxUyaAkWp/view?usp=share_link). He is a co-author on the [global LAMP consortium review paper](http://bit.ly/gLAMP-review) which appeared in a [special issue of the Journal of Biomolecular Techniques](https://abrf.memberclicks.net/jbt-2021-september-issue).
Our facility is 2,200 sqft of joint lab and office space in Portola Valley, CA, 10 minutes from Stanford University.
FloodLAMP is majority self-funded, with $975K in SAFE’s ($500K founder, $475K angels) and a $500K founder loan, convertible to a SAFE. Our revenue to date is $234,352.
## Growth
This proposal for funding provides the resources needed to bring much of the work we’ve done during the pandemic to fruition. Many of these are significant accomplishments in their own right, yet they are also steps to building something much bigger and delivering globally impactful solutions in disease detection.
Regarding open EUAs, it should be noted that obtaining the EUAs cited in this proposal will likely require federal agency support due to FDA policy changes in 2021. We think that funding from Balvi, along with publication and outreach, will generate major momentum and galvanize our network, including foundations and NGOs active in pandemic response. We’re hopeful this will lead to support and potential funding from RADx or BARDA. The need for public-private partnerships in COVID/pandemic testing is often highlighted, and we agree. Our goal is to bring many resources to bear on the problem of pandemic testing and help provide efficient avenues to translating funding to actual capability. We are cautiously optimistic as initiatives such as the [White House National Biodefense Plan](https://www.whitehouse.gov/wp-content/uploads/2022/10/National-Biodefense-Strategy-and-Implementation-Plan-Final.pdf) and [World Bank Pandemic Fund](https://www.worldbank.org/en/programs/financial-intermediary-fund-for-pandemic-prevention-preparedness-and-response-ppr-fif) spin up. As was the case during the pandemic, these “plans” are very light on details. We see potential for FloodLAMP to garner attention as we are offering real solutions, both at the level of technology and programs, as well as the systemic/policy level. Publishing our work soon will be key to getting involved with these larger pandemic preparedness and response efforts.
Our IP offers the potential for growth through licensing and partnerships. Our [first patent application](https://drive.google.com/file/d/1QRwe6OzAOEfTtnd8rpgYurZL7dRxpsl-/view?usp=share_link) has been published and has broad coverage of inventions related to on-the-fly (outside the lab) pooled sample collection. We filed this patent as a PCT and received a favorable written opinion from the US patent office, which granted us expedited examination for our regular US patent application. We have filed an additional provisional patent application covering other program related inventions and a 161 page provisional on the next generation platform. Given our open source approach and public benefit mission, we have carefully considered options around IP issues. We included as a deliverable the execution of standard licenses to open up access to our IP while maintaining the option to share in profits with better resourced commercial partners. We will consider non-commercial end-use royalty free licenses and open sourcing the code for our new web app. We do think licensing and IP need to be a core competency of the company, as we see a big opportunity to license test IP from universities and offer a commercialization model that maximizes impact while maintaining a modest royalty structure.
Momentum gained from Balvi funding will allow us to fully capitalize on the many relationships we have developed over the course of our work. In particular, we have developed a good relationship with [New England Biolabs](https://www.neb.com/), the largest manufacturer of enzymes for molecular biology in the world. NEB is a critical global supplier for biosecurity and an outlier in the industry, being so large yet still privately held. They were officially certified as a B corp and actively work globally on mission-driven programs and technology transfer. They have donated reagents for several FloodLAMP pilots and collaborations, both in the U.S. and in Colombia and Brazil. NEB is the recognized leader in LAMP, and while we do plan to diversify and validate our test with other LAMP master mixes (several companies such as Thermo and Meridian have commercialized products during the pandemic), NEB has important IP on the inclusion of thermolabile nucleotides into LAMP amplification. This greatly reduces the impact of any amplicon contamination and we believe is a key enabler for the decentralization of LAMP based testing. In addition they acquired the top lyophilization company, Fluorogenics, last year and so have key expertise and technology for OTC/POC LAMP based devices, such as our next generation platform.
FloodLAMP was invited to the NEB campus in Massachusetts in March of this year and gave a talk on FloodLAMP’s work to the company. We have had multiple meetings with senior management and they have expressed a deep interest in our mission and goals. NEB has provided a [letter of support](https://drive.google.com/file/d/1IPgF-HJRjP2sd0NX_MOf1pSXo2bHeUGO/view?usp=share_link) for grant applications to BARDA. Balvi funding will allow us to collaborate with them on both technical development and commercialization of inexpensive LAMP test kits, and also on regulatory authorizations through the WHO.
Another key collaborator is [Anne Wyllie](https://ysph.yale.edu/profile/anne-wyllie/), a researcher at the Yale School of Public Health, founder of [SalivaDirect](https://ysph.yale.edu/salivadirect/), and a member of our Scientific Advisory Board. Balvi funding will allow us to work with her and the SalivaDirect team on open source protocol FDA approvals. It was through Anne that we learned about this important regulatory development in the fall of 2020. Anne is a force of nature and deeply committed to openness (see [link](https://docs.google.com/document/d/1GKlS-Ln69ZiPpXdfgpHLHMXGCsbkIsIufwRrbJ1WCIg/edit?usp=sharing) for more details). She shared her full EUA submission with us as we were working on our EUAs and fielded many questions. Anne also shared legal agreements for labs and states and joined our call with FDA reviewers in October of 2021. Over the last 2 years she has led more than 20 amendments to the SalivaDirect EUA and formed key industry partnerships. Her experience would be tremendously helpful for our regulatory efforts, and formally partnering with SalivaDirect could lead to sustained engagement with the FDA prior to BARDA/RADx funding. We’ve included a line item in our budget for consulting fees for SalivaDirect, which is in the process of spinning out from Yale to form a non-profit. They would be a great organization for Balvi to consider funding.
FloodLAMP was spun out from a 501(c)3 STEM education non-profit. Operating at the intersection of for-profit and non-profit has been challenging, and we are eager to legally codify our public benefit commitments. A potential scenario that looks promising is forming a DAO. FloodLAMP could stay a PBC or transition to a non-profit, and be governed by the DAO. We have no experience in DAOs, blockchain, or web3, though we do have close contacts with experience. A DAO could align the incentives of a range of people and organizations around the focused mission of universal pandemic testing. Some specific aspects of the space and our goals that may make a DOA structure a good fit are:
- enabling the grass roots pull of testing programs into communities or countries by organizing local support and labor, applying specific geographic and technical knowledge, matching with funding, and facilitating the needed physical and digital resources;
- using the Rights of Reference (ROR) sharing mechanisms for regulatory validation data to expedite and lower the costs for test approvals - ROR are very powerful and seldom used (for more info [see Randy’s discussion on the this with the FDA](https://docs.google.com/document/d/1mU4CYHEAUiRaP3gugs2NxJkAl9yAUxi-hxGZ_o276dg/edit?usp=share_link));
- drawing on the expertise of many scientists in making key decisions about what tests to invest in for regulatory approvals and manufacturing scale up – this could create an influential new voice in the space, but notably one that is executing rather than only advocating;
- automatically distributing resources (via smart contracts) when triggering events occur or governing decisions are made, speeding response in an emergency.
Perhaps most important, the transparency in activities and governance of a DAO, could build much needed trust. Most of this could be accomplished within a standard organizational structure as well, however a DAO could potentially be more impactful.
Linked documents and a few others, including our FDA submissions, are in this openly shared google drive folder:
[Balvi <> FloodLAMP Shared Folder](https://drive.google.com/drive/folders/1Myhwp0Hl18SzGkUGTHkSKfeSzOQTX8kR?usp=share_link).
[FloodLAMP FDA and Regulatory Documents](https://drive.google.com/drive/folders/1Q6lMi3OvjMRYTlGmzRxVLFxe61Y17Nhr?usp=share_link)
[FloodLAMP - COVID-19 Tests Summary.pdf](https://drive.google.com/file/d/1dvyU-HwsN_aRpsMkBTSFVx6Dt82jh5nc/view?usp=share_link)
[FloodLAMP - FDA Foundation Presentation.pdf](https://drive.google.com/file/d/1y0Bb-8Knjqaps2er5MMsg1uimw22bMPP/view?usp=share_link)
[FloodLAMP Preschool Program Description.pdf](https://drive.google.com/file/d/16szPDXq_8QL9epOubYITPbUNepFSUZYN/view?usp=share_link)
We look forward to your feedback and questions!
# 4,512 Balvi Proposal 2 - FloodLAMP Open Source COVID Screening (Dec 2022 - 300K - Funded).md
METADATA
last updated: 2026-03-06 by BA
file_name: Balvi Proposal 2 - FloodLAMP Open Source COVID Screening (Dec 2022 - 300K - Funded).md
file_date: 2022-12-06
title: Balvi Proposal 2 - FloodLAMP Open Source COVID Screening (Dec 2022 - 300K - Funded)
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summary_short: The December 6, 2022 Balvi proposal outlines FloodLAMP’s plan to scale open-source, decentralized infectious disease screening built around extraction-free LAMP testing, self-pooled swab collection, and supporting digital tools, emphasizing decentralization, low cost, and open-protocol regulatory pathways. It summarizes 11 pilot programs (including municipal EMS and school deployments) and requests Balvi funding to open source program materials, publish pilot data, and run clinical studies to support future FDA EUA submissions. It also provides company background, partnerships (notably NEB and SalivaDirect), an IP and licensing approach, and a brief Q&A on licensing intentions and expected funding decision timing.
CONTENT
***INTERNAL TITLE:*** FloodLAMP: open source decentralized infectious disease screening.
Balvi Proposal - December 6, 2022
FloodLAMP Biotechnologies, PBC
Randy True randy@floodlamp.bio
We think that the best, and perhaps only, way to have stopped the spread of the SARS-CoV-2 virus was with early, broad based testing. The U.S. and the other countries (with the exception of China) still lack the capability to carry out large scale disease screening. As a result, we remain vulnerable to variants and even more worrying, to new, more deadly pathogens. Mass testing should be a cornerstone of pandemic preparedness and response, but many complex, interconnected problems need to be overcome in order to achieve this important capability.
FloodLAMP Biotechnologies is a Public Benefit Corporation solely focused on solving these problems and helping to deliver universally accessible pandemic response screening. Our assumptions are:
1. **Decentralization** is needed – the central lab model failed in the U.S. during the COVID-19 pandemic. Anyone or any organization needs to be able to purchase and run testing, with no or very streamlined oversight.
2. **Isothermal molecular** will win – for mass testing programs over antigen, due to better accuracy and flexibility. Molecular is quicker to adapt to new targets and more efficient for groups running point-of-need testing. Isothermal (LAMP) has revolutionary potential but so far the commercial focus is on expensive, single use/one-at-a-time devices. Further developing LAMP modalities can unlock the entire space.
3. **Cost** must be low – $5 or less per sample, ideally down to $1 (achievable now with self-pooling).
4. **Open** is needed – the molecular diagnostics industry’s standard business model is siloed, proprietary technology and 80-90% margins. A new paradigm of “open source protocol” FDA approvals that fully disclose chemistry and primer sequences can have huge impact due to global regulatory harmonization.
5. **Integrated innovation** is needed – achieving mass scale at low cost will require progress on policy, technology, programs, and business models – all planned and executed to work together.
Over the last year and a half, we have completed 11 pilot screening programs that are affordable, locally controlled, and can be scaled in a decentralized manner. We have considered not only assay chemistry but also operational configurations, enabling software, and regulatory pathways. The programs use what we consider to be the best current technology stack: isothermal molecular amplification ([LAMP using NEB Master Mix](https://www.neb.com/applications/dna-amplification-pcr-and-qpcr/isothermal-amplification/loop-mediated-isothermal-amplification-lamp)), extraction-free assay chemistry ([Rabe-Cepko protocol](https://www.pnas.org/doi/10.1073/pnas.2011221117)), and self-pooled swabs. In the majority of these pilots, we provided turn-key, in-house programs that included all of the physical materials, digital tools, training and support, with the partner organizations providing the space and staffing. The largest programs were ~1,000 person municipal workforces in two cities in Florida, run by the Emergency Medical Services departments. They scaled to thousands of samples per week during the Omicron surge, screening all first responders regularly. Both cities made our program mandatory despite having access to PCR testing services and practically unlimited antigen tests. We also have deployed successful school pilots that have used our novel at-home self-pooled sample collection, including Abrome in Austin, TX which received Balvi funding.
We are seeking funding from Balvi to publish our work, open source our current programs, and at the same time build the foundation for an enduring entity to help achieve universal access to disease testing, first for all known pandemic-threat pathogens, and then more broadly for improving global health. Key progress on the program and policy fronts can be made, especially with respect to open source FDA approvals and clarity on non-diagnostic testing regulations. On the technical front, our plans include developing a next generation rapid molecular OTC, POC/PON platform (for which we have filed IP and applied for [RADx funding](https://www.poctrn.org/web/radx-tech-high-performance-tests)). There is significant overlap between further developing our current platform and the next gen one, such as bridge assay development work. Please see our [RADx submission](https://docs.google.com/document/d/1FD3-N6AC2PQKKS_WpqtdQ1FnSvZAhJdyZrOcnaXb_AI) for details about this as well as information about our pilots, test performance, regulatory filings, and technology development plans.
_FLOODLAMP ARCHIVE FILE PATH:_ data/floodlamp/various/fl-proposals/RADx 2022 Submitted Proposal - FloodLAMP (Oct 2022 - 3M - Not Funded).md
The following is the set of deliverables we propose. The majority of these have a great deal of groundwork already laid and can proceed in parallel.
## Deliverables
| Deliverables | Impact | Estimated Timeline |
|---|---|---|
| **1. Open source programs**
1A. Website openly disseminating all program information, guides, and supporting docs.
1B. Support for multiple profiles and scales. | • Enablement of orgs seeking to bring up locally controlled testing.
• Initiates broad-based feedback.
• Demonstrates new open, cooperative approach. | 1A. 4-10 weeks
1B. 8 weeks (beta) |
| **2. Publication**
2A. Publish data from 11 pilots programs using LAMP-based COVID surveillance.
2B. Preprint + submission to open access peer reviewed journal.
2C. Website update and outreach when preprint goes live. | • Opens avenues to obtain help and further funding from PPR allies.
• Gets attention of U.S. federal agencies (CDC, ASPR, NSC, OSTP).
• Establishes company credibility.
• PR opportunity.
• Stimulates consideration of mass testing for PPR in the U.S. | 8 weeks |
| **3. Clinical studies and FDA EUA submissions**
3A. Clinical studies to gather data needed to support FDA EUA submissions. | • Key step to obtaining OS EUA, which
○ establishes new OS paradigm for IVD diagnostics at FDA;
○ enables global dissemination.
• Proves out new powerful study design that combines non-dx, organization based screening. | 12 weeks |
||
## Budget
The budget below is a breakdown of spending to meet the proposed deliverables.
[Balvi Proposal 2 - Budget](https://docs.google.com/spreadsheets/d/1vcN4BmShRpY2CXkC9sAJxAGkqjc9My8eEk-Q5Q7dwZ0/edit?usp=drive_link)
### Budget Table 12-6
| $130,000 | Open Source Platform |
|----------|------------------------------------------------------------------------|
| $90,000 | OS Platform - new CYOA website |
| $25,000 | Legal IP - open license w commercial terms (app and test) |
| $15,000 | Comms - Publication, Outreach, Community, PR, Summit, Interview Series |
||
| $100,000 | Clinical and Regulatory |
|----------|-----------------------------------------------------------------------|
| $20,000 | 10K Test Kits for Clinical Studies w Surveillance ($2/kit for NEB MM) |
| $50,000 | Regulatory Consulting (Arete, SalivaDirect partnership) |
| $30,000 | Clinical Studies Site Bring Up & Maintenance |
||
| $70,000 | Staff | 3 | heads | | |
|---------|--------------------|---------|-------------|---|----|
| $60,000 | Employee Salaries | $20,000 | salaries/mo | 3 | mo |
| $13,500 | Benefits and Taxes | 22.5% | overhead |
||
| $300,000 | TOTAL PROPOSAL |
|----------|----------------|
## FloodLAMP Company Information
FloodLAMP Biotechnologies was incorporated in Delaware on 8/3/2020 as a Public Benefit Corporation. Our charter states “the specific public benefit that the Corporation will promote is the development of open protocols and the implementation of large scale disease screening for infectious disease for the benefit of the public.”
We are currently 4 employees, 2 full time and 2 part time. Please see the last portion of our recent [RADx funding submission](https://docs.google.com/document/d/1FD3-N6AC2PQKKS_WpqtdQ1FnSvZAhJdyZrOcnaXb_AI) for profiles of our team members. Here is a more detailed bio for our CEO and founder, Randy: [Randall True Biosketch](https://drive.google.com/file/d/1822shorursMdugM0lk6Xx4RbZpnQjot0/view?usp=sharing). He is a co-author on the [global LAMP consortium review paper](https://drive.google.com/file/d/1qdf-dL2cmbB7aK4rw57CgjPmWQ9K5X0F/view?usp=drive_link) which appeared in a [special issue of the Journal of Biomolecular Techniques](https://abrf.memberclicks.net/jbt-2021-september-issue).
_FLOODLAMP ARCHIVE FILE PATH:_ various/glamp/gLAMP Global Consortium - JBT Review Paper (Sept 2021).md
Our facility is 2,200 sqft of joint lab and office space in Portola Valley, CA, 10 minutes from Stanford University.
FloodLAMP is majority self-funded, with $975K in SAFE’s ($500K founder, $475K angels) and a $500K founder loan, convertible to a SAFE. Our revenue to date is $234,352.
## Growth
This proposal for funding provides the resources needed to bring much of the work we’ve done during the pandemic to fruition. Many of these are significant accomplishments in their own right, yet they are also steps to building something much bigger and delivering globally impactful solutions in disease detection.
Regarding open EUAs, it should be noted that obtaining the EUAs cited in this proposal will likely require federal agency support due to FDA policy changes in 2021. We think that funding from Balvi, along with publication and outreach, will generate major momentum and galvanize our network, including foundations and NGOs active in pandemic response. We’re hopeful this will lead to support and potential funding from RADx or BARDA. The need for public-private partnerships in COVID/pandemic testing is often highlighted, and we agree. Our goal is to bring many resources to bear on the problem of pandemic testing and help provide efficient avenues to translating funding to actual capability. We are cautiously optimistic as initiatives such as the [White House National Biodefense Plan](https://www.whitehouse.gov/wp-content/uploads/2022/10/National-Biodefense-Strategy-and-Implementation-Plan-Final.pdf) and [World Bank Pandemic Fund](https://www.worldbank.org/en/programs/financial-intermediary-fund-for-pandemic-prevention-preparedness-and-response-ppr-fif) spin up. As was the case during the pandemic, these “plans” are very light on details. We see potential for FloodLAMP to garner attention as we are offering real solutions, both at the level of technology and programs, as well as the systemic/policy level. Publishing our work soon will be key to getting involved with these larger pandemic preparedness and response efforts.
Our IP offers the potential for growth through licensing and partnerships. Our [first patent application](https://drive.google.com/file/d/19qoJLj-dDQs0_ksksWlYg-l-eEssrmyX/view?usp=drive_link)
_FLOODLAMP ARCHIVE FILE PATH:_ various/fl-patent/FloodLAMP Patent Application - US20240139745A1 - from Google Patents.md
has been published and has broad coverage of inventions related to on-the-fly (outside the lab) pooled sample collection. We filed this patent as a PCT and received a favorable written opinion from the US patent office, which granted us expedited examination for our regular US patent application. We have filed an additional provisional patent application covering other program related inventions and a 161 page provisional on the next generation platform. Given our open source approach and public benefit mission, we have carefully considered options around IP issues. We included as a deliverable the execution of standard licenses to open up access to our IP while maintaining the option to share in profits with better resourced commercial partners. We will consider non-commercial end-use royalty free licenses and open sourcing the code for our new web app. We do think licensing and IP need to be a core competency of the company, as we see a big opportunity to license test IP from universities and offer a commercialization model that maximizes impact while maintaining a modest royalty structure.
Momentum gained from Balvi funding will allow us to fully capitalize on the many relationships we have developed over the course of our work. In particular, we have developed a good relationship with [New England Biolabs](https://www.neb.com/), the largest manufacturer of enzymes for molecular biology in the world. NEB is a critical global supplier for biosecurity and an outlier in the industry, being so large yet still privately held. They were officially certified as a B corp and actively work globally on mission-driven programs and technology transfer. They have donated reagents for several FloodLAMP pilots and collaborations, both in the U.S. and in Colombia and Brazil. NEB is the recognized leader in LAMP, and while we do plan to diversify and validate our test with other LAMP master mixes (several companies such as Thermo and Meridian have commercialized products during the pandemic), NEB has important IP on the inclusion of thermolabile nucleotides into LAMP amplification. This greatly reduces the impact of any amplicon contamination and we believe is a key enabler for the decentralization of LAMP based testing. In addition they acquired the top lyophilization company, Fluorogenics, last year and so have key expertise and technology for OTC/POC LAMP based devices, such as our next generation platform.
FloodLAMP was invited to the NEB campus in Massachusetts in March of this year and gave a talk on FloodLAMP’s work to the company. We have had multiple meetings with senior management and they have expressed a deep interest in our mission and goals. NEB has provided a [letter of support](https://drive.google.com/file/d/1IPgF-HJRjP2sd0NX_MOf1pSXo2bHeUGO/view?usp=share_link) for grant applications to BARDA. Balvi funding will lay the groundwork to progress our relationship with NEB, with future areas of work including technical development, commercialization of inexpensive LAMP test kits, and potentially collaboration on regulatory authorizations through the WHO.
Another key collaborator is [Anne Wyllie](https://ysph.yale.edu/profile/anne-wyllie/), a researcher at the Yale School of Public Health, founder of [SalivaDirect](https://salivadirectinc.org/), and a member of our Scientific Advisory Board. Balvi funding will allow us to work with her and the SalivaDirect team on open source protocol FDA approvals. It was through Anne that we learned about this important regulatory development in the fall of 2020. Anne is a force of nature and deeply committed to openness (see [Anne Wyllie Nomination for FDA Foundation 2022 Innovations in Regulatory Science Awards](https://docs.google.com/document/d/16muU80i9sAFPsCQNosyrK6ZYJqMPxf0gSqZcsudqYZM/edit?usp=drive_link) for more details).
_FLOODLAMP ARCHIVE FILE PATH:_ regulatory/open-euas/Anne Wyllie Nomination for FDA Foundation 2022 Innovations in Regulatory Science Awards.md
She shared her full EUA submission with us as we were working on our EUAs and fielded many questions. Anne also shared legal agreements for labs and states and joined our call with FDA reviewers in October of 2021. Over the last 2 years she has led more than 20 amendments to the SalivaDirect EUA and formed key industry partnerships. Her experience would be tremendously helpful for our regulatory efforts, and formally partnering with SalivaDirect could lead to sustained engagement with the FDA prior to BARDA/RADx funding. We’ve included a line item in our budget for consulting fees for SalivaDirect, which is in the process of spinning out from Yale to form a non-profit. They would be a great organization for Balvi to consider funding.
FloodLAMP was spun out from a 501(c)3 STEM education non-profit. Operating at the intersection of for-profit and non-profit has been challenging, and we are eager to legally codify our public benefit commitments. A potential scenario that looks promising is forming a DAO. FloodLAMP could stay a PBC or transition to a non-profit, and be governed by the DAO. We have no experience in DAOs, blockchain, or web3, though we do have close contacts with experience. A DAO could align the incentives of a range of people and organizations around the focused mission of universal pandemic testing. Some specific aspects of the space and our goals that may make a DOA structure a good fit are:
- enabling the grass roots pull of testing programs into communities or countries by organizing local support and labor, applying specific geographic and technical knowledge, matching with funding, and facilitating the needed physical and digital resources;
- using the Rights of Reference (ROR) sharing mechanisms for regulatory validation data to expedite and lower the costs for test approvals - ROR are very powerful and seldom used - for more info [see Randy’s discussion on the this with the FDA](https://docs.google.com/document/d/1jZzEumjRYUOK31Cz-sUQkfONjqOja1f_YqPcNduwHA8/edit?usp=sharing);
_FLOODLAMP ARCHIVE FILE PATH:_ regulatory/fl-fda-correspondence/2020-12-09_FloodLAMP FDA Townhall Engagement on Open Source FDA IVD EUAs and Generic Molecular Tests.md
- drawing on the expertise of many scientists in making key decisions about what tests to invest in for regulatory approvals and manufacturing scale up – this could create an influential new voice in the space, but notably one that is executing rather than only advocating;
- automatically distributing resources (via smart contracts) when triggering events occur or governing decisions are made, speeding response in an emergency.
Perhaps most important, the transparency in activities and governance of a DAO, could build much needed trust. Most of this could be accomplished within a standard organizational structure as well, however a DAO could potentially be more impactful.
Linked documents and a few others, including our FDA submissions, are in this openly shared google drive folder:
FloodLAMP FDA and Regulatory Documents (link replaced with FloodLAMP Archive Folder [Regulatory](https://drive.google.com/drive/folders/1fI06ZIDsGmi5pdxFSrsMEoSDPEzxNW3x?usp=drive_link))
[FloodLAMP - COVID-19 Tests Summary.pdf](https://drive.google.com/file/d/1Y8Q09VdMMTB1PnBQv2xJuvRAuvq8yv1-/view?usp=drive_link)
[FDA Reagan Udall Foundation - FloodLAMP Presentation (4-21-2022)](https://docs.google.com/presentation/d/1y_Svu_c7pa4QZUijkVRCnFmND6Sy5L7LI0LzldVH4A8/edit?usp=drive_link)
[FloodLAMP Whitepaper - California Preschool Family Pooled Screening Pilot (June 2022)](https://docs.google.com/document/d/1TOnklq-65XUX-v-li018rteK9jeL8NgqbNrtbndgD_o/edit?usp=drive_link)
We look forward to your feedback and questions!
## Q&A
*Tas D.: How would the test be licensed? Would you be willing to open source it within some parameters?*
Randy True: Yes, absolutely. We are intending to open up access to this and our other IP, probably through non-exclusive commercial licenses. We included this as a deliverable (6A). We've done some of the legal groundwork for this with a licensing attorney and the Harvard office of technology licensing, around the Rabe Cepko LAMP test IP. The IP for the next gen platform has a different profile that our current tests (Rabe Cepko) because it's a device rather than a liquid phase test. For liquid phase tests, we have the open source protocol FDA pathway.
*Tas D.: When do you expect a decision about this?*
Hopefully by mid December. I'm planning to reach out to a contact who is a program manager at RADx next week to try and learn more about the process.
# 2,915 Florida State EMS Proposal - FloodLAMP (Jan 12 2022).md
METADATA
last updated: 2026-03-06 by BA
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summary_short: The “Resilient Florida” proposal outlines a statewide plan to stand up locally operated, non-diagnostic rapid molecular surveillance testing sites at emergency response agencies using FloodLAMP’s pooled colorimetric LAMP system and integrated digital tools. It describes a phased rollout (Phase 1: 10 sites; Phase 2: 50 sites plus mobile; Phase 3: preparedness) including turnkey equipment packages, technician training/certification, weekly kit resupply, and responsibilities split among FloodLAMP, the State, and local agencies. It also provides projected throughput and staffing models and a budget estimating about $966K for Phase 1 and $4.36M for Phase 2, positioning the capability as reusable infrastructure for future pathogens by swapping primer sets.
CONTENT
***INTERNAL TITLE:*** Resilient Florida
A proposal to build locally controlled, rapid molecular disease surveillance capability statewide.
Prepared by:
**Randy True** – CEO, FloodLAMP Biotechnologies, PBC
randy@floodlamp.bio
**Kevin Schallert** – COO, FloodLAMP Biotechnologies, PBC
kevin@floodlamp.bio
## Table of Contents
**[Table of Contents](#table-of-contents) 2**
**[About FloodLAMP](#about-floodlamp) 3**
**[Resilient Florida Overview](#resilient-florida-overview) 3**
**[Proposal Summary](#proposal-summary) 3**
**[Successful Pilots](#successful-pilots) 3**
**[Key Outcomes of Statewide Rollout](#key-outcomes-of-statewide-rollout) 4**
**[Party Responsibilities](#party-responsibilities) 4**
**[Phase 1 Implementation Plan - 10 Sites](#phase-1-implementation-plan---10-sites) 5**
[Systems](#systems) 5
[Test Kits](#test-kits) 5
[Digital Tools](#digital-tools) 6
**[Phase 2 Implementation Plan - 50 Sites plus Mobile](#phase-2-implementation-plan---50-sites-plus-mobile) 7**
**[Phase 3 – Preparedness](#phase-3-preparedness) 7**
**[Proposal Financials](#proposal-financials) 8**
## About FloodLAMP
FloodLAMP’s mission is to enable globally scalable mass disease screening, for COVID-19 and beyond. We are a Public Benefit Corporation focused on affordable, distributed molecular testing. We have innovated on multiple fronts to create a best-in-class platform that is unique in the testing space. We are rapidly expanding to high priority populations during the pandemic to address the acute unmet need for accessible, effective testing.
## Resilient Florida Overview
FloodLAMP is eager to work with the State of Florida to rapidly develop multi-scale molecular surveillance capability at local emergency response agencies. The State is well positioned to support the bring up of processing sites at local emergency agencies because of the cost and time savings inherent to parallel training and deployment. This capability will provide local agencies another viral suppression tool to protect critical human infrastructure at a low cost during normal operations and in emergency response. State sponsored deployments are well suited to hand off to local agency operation once local staff are trained, and local agencies can source test kits on an as needed basis from their discretionary budgets.
The current configuration of our test system supports non-diagnostic testing of COVID-19. In the future, new disease targets can be added, as required by local and state agencies, by changing out only one component of the test (the primers). This plug-and-play capability is a key feature of molecular tests, however most companies in the industry operate as closed, proprietary systems, keeping their test ingredients secret (including the test chemistry and primer sequences). FloodLAMP takes the opposite approach and as a public benefit company, we have a commitment to open protocols and transparency built into our corporate charter. What this means for the Resilient Florida proposal is that the physical infrastructure deployed along with the experience gained through running surveillance screening programs at scale, in partnership with FloodLAMP, extends far beyond this pandemic and specific virus. We’re helping the State of Florida build a new tool, to use when needed for pathogen detection, pandemic response, and flexible critical workforce disease surveillance screening. Together we're adding to local resilience and positioning communities to self-sufficiently respond to the challenges they face.
## Proposal Summary
FloodLAMP proposes the State of Florida lead the rapid bring up of sites across the state in a two phase roll out. The State role will be strictly capability building toward local resilience and handoff whereas the local partner agencies will assume financial and program management responsibility. Phase 1 will bring FloodLAMP testing assets in-house to 10 urban, suburban, and rural sites and Phase 2 will expand five–fold. FloodLAMP is equipped to begin Phase 1 immediately and Phase 2 within 10 days of initiation, with completion of both phases within 30 days. The proposal assumes active buy-in from local partner agencies.
## Successful Pilots
FloodLAMP has proven that locally controlled surveillance testing can be quickly developed, cheaply maintained, rapidly expanded and sustainably maintained by local agencies. FloodLAMP partnered with the City of Coral Springs and the Town of Davie to develop in-house non-diagnostic screening capability. In two weeks, FloodLAMP converted empty rooms into processing sites (minimalist labs), trained light duty fire fighters to manage, process, interpret and manage test results. The programs maintained low volume COVID-19 suppression screening during low community prevalence times at a minimal test kit and staff cost. The cities were well equipped to respond to increasing case rates with a max capacity of thousands of people tested per day. This capability has reduced workforce infection spread, time to return to work, and informed clinical referrals and therapeutics. Excitingly, confidence in the core test and program have greatly increased, supplanting central lab PCR testing as the most trusted method. It has led to an order of magnitude of increased testing with cost savings to the city general fund. These pilots have shown the resiliency value afforded to low cost and easy to maintain molecular surveillance capability.
## Key Outcomes of Statewide Rollout
- Independence and flexibility in implementation of highly accurate, high value infectious disease detection;
- Immediate suppression of COVID19 in critical populations including infrastructure and first responders, for improved health and reduced staffing shortages;
- Surge response capacity to seasonality or new variant outbreaks;
- Coordinated network of EMS sites and personnel trained in all aspects of surveillance program implementation;
- Multi-scale capability that spans metro and rural regions;
- Reduce load and costs from clinical PCR tests for screening;
- Transition from state-sponsored buildout to local management, maintenance, and funding.
## Party Responsibilities
- FloodLAMP
- Deliver test systems and all-in test kits
- Test technician and participant training
- Digital app and management software
- Support and service
- Quality control
- Surge staffing
- State of Florida
- Parallel training and deployment coordination
- Phase 1 site selection
- Phase 1 and 2 funding
- Local agency
- Staffing (need to complete FloodLAMP certification )
- Space
- Program management
- Sample collection logistics
- Communication of inventory
- Quality control compliance
- Resource commitment to fund tests moving past deployment phase
## Phase 1 Implementation Plan - 10 Sites
Phase 1 of the rollout comprises bringing up 10 new sites in counties that have critical human infrastructure testing needs. Sites are at the discretion of Florida state leadership and may be a mix of high population counties and metro areas such as Miami-Dade, Palm Beach and Tampa, as well as lower density regions such as Alachua and Leon counties.
### Systems
Each FloodLAMP site includes all the equipment and supplies for turnkey operations (the “system”). FloodLAMP calibrates the equipment and coordinates the standard manufacturer warranty.
3 different system configurations are provided:
| | Pipettes | Prep Heater | Amp Heater | Pool Level | Max Capacity per 24hrs | Recommended Daily Max Throughput | Recommended Staff (single shift) |
|---|---|---|---|---|---|---|---|
| **System Large** | 2 premium sets | 2 x Water Bath | 2 x 96 Dry Bath | 4 | 40,000 | 10,000 | 6 |
| **System Medium** | 1 premium set | 2 x Water Bath | 1 x 96 Dry Bath | 4 | 20,000 | 6,000 | 4 |
| **System Mobile** | 1 premium set | 1 x 15 Dry Bath | 1 x 40 Dry Bath | 2 | 3,500 | 1,000 | 1 |
||
Rapid stand-up and validation assigns a FloodLAMP staff scientist to synchronously support the remote set up of the site and initial validation runs. This process quickly turns an empty room into a fully operational test processing site with high throughput capability.
Staffing for the sites will be a mix of FloodLAMP Test Technicians (test operators) and newly trained EMS/municipal staff. Technical training and certification is achieved through a remote training course with live, as-needed support to train agency personnel to run the FloodLAMP QuickColorTM test system. Completion comes with a FloodLAMP certification.
### Test Kits
FloodLAMP All-in Test Kits are unique in the space because they are inclusive of all components required to run large scale testing programs. The kits include collection materials that test up to four people per pool ($2 per person tested), software, and a digital app to manage collection, operations and reporting, as well as all laboratory consumables and reagents. FloodLAMP manages test kit orders for processing sites so they can easily update expected throughput and have their inventory restocked each week on a per test basis. All-in Test Kits contain all of the reagents (liquids needed for the test) and plastic consumables (tubes, pipette tips, plates), as well as the sample collection kit materials (QR coded tubes and nasal swabs), necessary to run the test. These are provided on a per reaction (or per pool) basis and indexed to the LAMP reaction master mix.
### Digital Tools
FloodLAMP has custom created digital tools to facilitate the testing process. They serve three key user groups:
1. **Participants**
- App for iOS and Android
- Supports at-home collection
- Collection workflow enables in-app accessioning of tubes (QR code scan) and listing of pool participants per tube
- Status/history view displays all collection events recorded in the system, and whether the screening is complete.
2. **Staff**
- App for iOS and Android
- Intake and track tubes
- Set status on test process (visible to participants)
- Report results on tubes
3. **Administrative Staff**
- Desktop web app
- Manage and update user accounts
- View comprehensive history of collected samples and status
- Search individual entries by tube ID or name
- Control settings for participant app information pages
## Phase 2 Implementation Plan - 50 Sites plus Mobile
Phase 2 builds on the Phase 1 deployments to scale up to 50 sites total. Additionally 10 mobile systems are provided for portable and/or rapid response testing needs.
Selection of deployment sites as well as implementation details will be informed by needs discovered during execution of Phase 1. Critical supplies for Phase 2 are secured by deposits included in Phase 1.
## Phase 3 – Preparedness
FloodLAMP will work directly with local agencies to sustainably manage test capability. FloodLAMP will work with the State of Florida on mobile and pop-up site infrastructure to add capacity during emergency response.
## Proposal Financials
| Item | Unit Type | Unit Cost | Phase 1 | Phase 1 Totals | Phase 2 | Phase 2 Totals |
|---|---|---|---|---|---|---|
| **Systems¹** | | | | | | |
| System Large | Per Site | $18,000 | 4 | $72,000 | 6 | $108,000 |
| System Medium | Per Site | $11,000 | 6 | $66,000 | 34 | $374,000 |
| System Mobile | Per System | $6,000 | | | 10 | $60,000 |
| Rapid Stand Up & Validation | Per Site | $8,000 | 10 | $80,000 | 40 | $320,000 |
| | | | | $218,000 | | $862,000 |
| **Staff²** | | | | | | |
| FloodLAMP Lab Technicians | Per Person Per Week | $5,000 | 20 | $100,000 | 80 | $400,000 |
| Technical Training & Certification | Per Person | $2,000 | 20 | $40,000 | 80 | $160,000 |
| | | | Subtotal | $140,000 | Subtotal | $560,000 |
| **Licenses** | | | | | | |
| FloodLAMP Digital Suite License | 1 year | incl with Test Kit purchase | | | | |
| FloodLAMP QuickColor(TM) COVID19 Test License | 1 year | incl with Test Kit purchase | | | | |
| **All-in Test Kits¹** | | | | | | |
| Reagents and Consumables | Per Reaction/Pool | $8 | 40,000 | $320,000 | 300,000 | $2,400,000 |
| Collection Kit Materials | Per 4 Person Pool | incl w Test Kits | 40,000 | | | |
| | | | Subtotal | $320,000 | Subtotal | $2,400,000 |
| **Deposits** | | | | | | |
| Systems | critical supplies | $1,200 | 40 | $48,000 | 50 | $60,000 |
| Test Kits | critical consumables | $0.80 | 300,000 | $240,000 | 600,000 | $480,000 |
| | | | Subtotal | $288,000 | Subtotal | $540,000 |
| | | | **Phase 1 Total** | **$966,000** | **Phase 2 Total** | **$4,362,000** |
||
**Terms**
(1) delivery 10 days from PO
(2) as needed and utilized, not to exceed without approval
# 7,513 RADx 2020 Submitted Proposal - FloodLAMP (Aug 2020 - 1M - Not Funded).md
METADATA
last updated: 2026-03-06 by BA
file_name: RADx 2020 Submitted Proposal - FloodLAMP (Aug 2020 - 1M - Not Funded).md
file_date: 2020-08-01
title: RADx 2020 Submitted Proposal - FloodLAMP (Aug 2020 - 1M - Not Funded)
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summary_short: The RADx Tech “FloodLAMP” Fast-Track application (Application 6207, June–July 2020) proposes scaling an extraction-free, colorimetric RT-LAMP mass screening program using flexible multi-stage pooling, centralized reagent production, and distributed deployment across existing labs to reach population-level throughput at ~$1 per result. It describes a pooled self-collection workflow (saliva or swabs), TCEP/EDTA heat inactivation, silica-based RNA capture to support very large pool sizes, and operational plans for staffing, logistics, data/software, and supply-chain resilience using readily available reagents and standard equipment. It outlines staged work packages focused on SOP hardening, pilot software, EUA submission with a clinical partner, large pilots across prevalence “tiers,” manufacturing scale-up, and training/support to enable rapid national rollout.
CONTENT
***INTERNAL TITLE:*** Flood LAMP - an immediately scalable SARS-COV-2 mass screening program
Application: 6207
Started at: 6/10/2020 08:08 AM Finalized at: 7/15/2020 06:12 PM
### Page: Applicant Information
The Fast-Track process is different from most solicitations to provide a rapid response to the massive and unique challenges created by the COVID-19 crisis. We encourage you to review information at the POCTRN RADX site LINK about the program and Fast-Track process before starting the application. Also, note that:
- Proposals awarded under this solicitation will be treated as a subaward to a cooperative agreement (see
PAR-17-453) and are required to comply with all of the NIH Standard Award Terms and Conditions available at this LINK [https://grants.nih.gov/grants-process/award/awards-conditions-and-information-for-nih-grants]
- You can save your application at any time, exit and return later to complete it.
- All questions marked with a * must be completed before an application can be submitted
- If you need help or have questions about the form, e-mail them to info.radx@poctrn.org and we will respond
as fast as possible.
### Project Title
Flood LAMP an immediately scalable SARS-COV-2 mass screening program
### Confirmation of direct SARS-COV-2 detection
Confirmed
### Proposed Solution Category
Scale-up
### FDA approval vehicle
Emergency Use Authorization
### Link to IFU
https:/www.fda.gov/media/138249/download
### Name of Organization/ Group submitting the application
Focus on Foundations 501(c)3 Nonprofit
### Website?
Yes
### Org/Group URL:
focusonfoundations.org
### Prior Contact with a POCTRN Center
No
### Important Notes About Managing Co-applicants and Submissions
While the Point of Contact is responsible for the work, the person who started this submission is referred to as the "Primary Co-applicant , who:
- Can add other applicants (by clicking on a "Manage Co-applicants" button in upper right of window). Note: You will be asked about project Team Members later.
- Can assign any co-applicant to assume the role.
- Is the only one who can submit an application when complete.
### Given (First) Name
Randall
### Family Name
True
### Title at Organization/ Group
Executive Director
### Preferred e-mail
randy@focusonfoundations.org
### Preferred phone number
+1 415-269-2974
The following questions are to help us understand the responses we are getting so we can improve our outreach they have no impact on our assessment of your application.
### State
California
### Organization/ Group Type
Non-Profit Lab/CRO
### Awareness
Website
### Page: Scale-up
### Scaled-up Testing Overview
The COVID-19 crisis is the worst public health disaster of our time, and the U.S. does not have a comprehensive testing strategy to contain the pandemic. New mass screening needs to be scaled quickly and coordinated with the current testing capacity. Fortunately, no new breakthroughs are needed to achieve this. A major cooperative effort, however, is urgently needed.
We propose a startup-like nonprofit to build the mass screening program, supported by government and academic institutions. The assay/program: - flexibly pools to hundreds of samples per tube - has already demonstrated 10 sample pools on real saliva; - uses standard lab equipment, no complex instrumentation; uses only readily available chemicals for front end inactivation and RNA purification; - uses colorimetric LAMP for fast, easy, binary readout; is 100% additive to current testing; - is extremely inexpensive ($1-2/reaction); - uses saliva or swabs; avoids commercial RNA extraction kits; avoids supply chain problems; has already been clinically validated; - was independently chosen for large scale screening by several groups.
$2.4M covers equipment for 600 stations (nominally 5 stations/lab but flexible). Each station runs 1,000 tubes/day. Central production and distribution of ready-to-use reagents, coupled with extensive training and support, achieve a massive economy of scale.
This new program, in coordination with current testing, enables us to scale to identify almost all active infections, containing outbreaks. At this testing volume, we can effectively end the COVID crisis, first in the U.S., then in the rest of the world.
Please describe the FDA approved test that you propose scaling. If more than one, choose the most common.
### Manufacturer
New England Biolabs
### Product name and model number
WarmStart Colorimetric LAMP 2X master mix M1 800B-1L
### Relationship w/ producer or distributor
The applicant is a different organization
### Relationship overview
Our organization has no affiliation with New England Biolabs or Color Genomics.
### CLIA status
Waived
### Sampling
Saliva, Nasal swab, Oral swab
### PPE/Biosafety Requirements
Safety is a top priority for the program, as are sample integrity and system efficiency. The primary mode of sampling is self collection, either at-home or on-site (i.e. a school or workplace). Routine COVID safety precautions will be practiced: masks, hand washing, and physical distance. A viral inactivation buffer (TCEP/EDTA) and heat step are used, greatly reducing risk. Lab personnel will follow BLS2 level requirements when possible. For on-site collection, personnel will typically inactivate samples prior to transport. If so, they will utilize a gown, N95 mask, and face shield while doing the inactivation, assuming they are available.
Please indicate the demonstrated performance parameters of the test's performance as accepted by the FDA
### Level of Detection (LoD)
Other units (define)
### Units
copies per microliter
### LoD
1
### Sensitivity %
90
### Specificity %
100
### Test time
70
### Any asymptomatic testing?
Don't know
To help us understand the way you propose scaling the throughput capacity of a test, please describe an envisioned scenario at the maximum throughput capacity using a proposed testing configuration. For example, describe this "max use" scenario in settings such as schools, universities, daycares, places of business, etc.
### Current Capacity
450
### Expected increased capacity
6800000
### Scenario
The above throughputs are for a single station and for 616 stations, both running in a pool-of- pools format with 45-50 samples per tube. The relevant metric for the large scale program we are building is the population level that can be screened per day, at what upfront capital cost and running cost. With 5 stations per lab, we can screen approximately 1.3M people per day by adding $20K of readily available, standard equipment to existing labs, at a labor + materials cost of about $30K/day. That would require staffing at each 5-station lab of about 50 technicians. The staffing and preparation of materials is done at a centralized facility for distribution to 100 such labs across the U.S. For the sample collection program, we anticipate large numbers of volunteers helping with coordination of screening their immediate communities.
The above scenario is for "green" populations, where the region or demographic has a prevalence of 1 in 30,000 (or less). Here, the labs receive pre-pooled tubes of 10 samples (0.5ml X 10 = 5ml in a 15ml centrifuge tube). They pull .67ml (13%) from 45 such tubes to make a pool of pools containing samples from 450 individuals. These 30ml are processed in a scaled up version of the Rabe Cepko assay protocol [1], in a 50ml tube. The volumes, pool sizes, and labware are all chosen to optimize lab efficiency.
A cornerstone of the screening program is the pooling flexibility. The same lab station can process tubes screening for the entire range of currently infectious prevalence:
Green: 1 in 30,0000 - 450/10 pooling, 266K people/day Yellow: 1 in 1,000 - 100/10 pooling, 36K people/day Orange: 1 in 100 - 10/1 pooling, 5K people/day Red: 1 in 33 - 5/1 pooling, 3K people/day
The key to achieving this pooling flexibility is the liquid phase nucleic acid binding step, currently accomplished with ultra inexpensive prepared silica microparticles. Alternatively the same can be accomplished with magnetic capture beads, and New Zealand has developed a low cost version of this that may be investigated.
Sampling is done very efficiently with at-home and on-site pooled self collection schemes. For both saliva and swab sample types, participants place their samples into the common pooled tube immediately. Under some high prevalence scenarios and for FDA EUA submission, participants will simultaneously collect individual samples, which will be bagged (barcode matching pooled tube), stored, and then only accessed if the pool is positive.
Samples are inactivated with TCEP/EDTA at a drop-off location or on-site. Pooled, inactivated tubes are delivered to the lab where processing proceeds with secondary pooling, followed by the assay protocol consisting of silica "glass milk" RNA purification and concentration, then the RT- LAMP reaction. Importantly, the highly pooled concentrated sample can go into a PCR reaction instead of LAMP, making the whole front end infrastructure plug-and-play with current PCR capacity.
[1] Rabe B, Cepko C. medXriv preprint 4-23-20 https://www.medrxiv.org/content/10.1101/2020.04.23.20076877V1
### Set-up
No
### Labor required
Role: Sample Collection Coordinator Description of duties: Oversees the sample collection at staffed drop off locations. Provides tubes and consumables. Ensure safety procedures are followed. Prepares collected tubes for safe transport back to the lab by courier. Expected level of training required: Can be certified with short on-line course Number required: 4400
Role: Courier Description of duties: Transports sample tubes in proper containment vessels (biosafety case), from sample collection site to lab. Using a separate courier to do this allows the Site Coordinator to continue to supervising the next batch of samples from the same site or to drive to a new site. Expected level of training required: No training Number required: 900
Role: Lab Technician Description of duties: Perform assay in the lab. Pipetting and standard incubation steps. Cleanliness and attention to detail a must. Since it's a single protocol with a small number of step, training of new technicians can be accomplished in one week. Expected level of training required: Requires professional training Number required: 5000
### Capital costs
10000000
### Cost per individual result
1
### Availability of consumables
Overall this proposal has very favorable supply chain characteristics. "Since the required reagents are easily manufactured by multiple manufacturers, access to this test does not rely on traditional commercial diagnostic supply chains that have hindered the broad distribution of SARS- CoV-2 testing. In addition, there is no need for de novo manufacturing. The reagents needed for this assay can be purchased by any laboratory from a number of sources, except for the colorimetric RT-LAMP master mix where the manufacturer has large-scale production in place with millions of reactions worth of product available." [2]. "A single lab can prepare enough for tens of millions of purifications in a day at a cost of less than $45 per 1 million purifications." [1] Primary bulk reagents needed are: TCEP, EDTA, Tris, PBS, EtOH, Nal, NaCL.
The Immediate pooling of 10 samples greatly saves on plastic tubes and tips. A wide variety of tubes may be used for the sample collection. For saliva, straws and widemouth tubes are used for collection, and transfer pipettes for self pooling. For nasal swabs, a variety of products can be validated. LAMP reactions are carried out in readily available 0.2ml PCR strip tubes. The supply chain for these will be investigated and dedicated manufacturing secured if necessary.
[2] Anahtar M. Clinical assessment and validation of a rapid and sensitive SARS-COV-2 test using reverse-transcription loop-mediated isothermal amplification. medXriv preprint 5-12-20. https://www.medrxiv.org/content/10.1101/2020.05.12.20095638V1
### Time to results
2
### Handling data
Data will be handled in the standard channels for clinical diagnostic testing, adding sample pooling information. Custom software will be used for sample registration, lab tracking, and results communication. Existing LIMS will be used for the lab.
The primary data generated will be name and contact information of the participants and the day/time of sample collection. Data sharing will be the subject of agreements and may vary by jurisdiction or group. Typically, transparency will be desirable and opt-in disclosure urged for members of groups that coordinate to be tested together because they belong to the same school or workplace. We will facilitate classification of participants into risk groups for optimal pooling through the use of transparent software tools, potentially including an anonymous version.
The important non-PII data from the screening program will be the geographic regions, participating organizations, and frequency of screening. The program will strongly encourage all participants to share this information in a legal way, and will create data visualizations and api access. This high degree of transparency will facilitate public trust in the program and encourage widespread adoption. Further, it will encourage volunteer efforts.
### What is needed?
What is crucially needed to realize this program is immediate support, in the form of 1) funding to rapidly grow the team and 2) connections to help the program integrate with existing public health efforts. Because there are no technical or scientific barriers, our efforts will primarily be focused on execution: scaling through sample pooling and launching an ambitious communications and sample collection scheme. The full Rabe Cepko assay protocol has been clinically validated [2 Anahtar reference above]. The RT-LAMP step is well proven, with an EUA by Color Genomics on 5/18. More recently, on 7/9 NEB launched an improved formulation of the master mix along with a new RUO product - SARS-CoV-2 Rapid Colorimetric LAMP Assay Kit. LAMP is exploding, being used at universities across the country and around the world (Univ of SC, Cornell, Univ of Vienna, Columbia to name just a few).
Funding Proper funding will dramatically accelerate all parts of the program in parallel: the pooling level LOD characterization, the clinical validation with partners toward IVD and LDT EUA's, the central lab production scale up of ready-to-go kits for distribution, the component stability studies, the pilot programs, the app and website development, the user testing for sample collection modes, the recruitment of labs across the country, the production of training materials, and the outreach to ready the public for participation.
Connections and Integration Connections with public health stakeholders and government decision makers will enable us to lead an an awareness campaign of the program's capability and create a distributed pull for its success. LAMP-based screening will likely have a significant impact on testing over the next 6 months, however with RADX support of this program, it can have a massive impact over the next 2 months, in time for school openings in the fall. We believe that a coordinated, realistic effort for identifying current infections and catching new ones will sway public sentiment and change the national dialogue from one of confusion and fear to one of collective effort and optimism. The vaccine is the long term solution. This mass screening program is the near term solution.
Acceptance of Sample Pooling China tested 9M people in 10 days in May. Amazon is building a central mega lab with 50K/day capacity, intending to test 1M employees. Both China and Amazon are doing pooling. They understand that pooling is critical to achieve the scale needed to identify active infections among a large population. The importance of pooling as a means for effectively screening large populations has been understood by some in the U.S. at least since early April. Stanford demonstrated it and published a preprint. However, they have not used it and recently stated they have no plans to because of their current excess unused capacity, running at the 20- 25% uti ilization of their 5K/day. Other high throughput academic labs have had similar low utilization of their capacity (CZI/UCSF).
This low utilization is because these labs' capacities have not been mated to ambitious, scalable sample collection programs and also because, in many cases, these labs are running expensive tests or have components with supply chain bottlenecks. Some testing companies are looking into pooling (Color) but the financial incentives are not in place. CMS high throughput reimbursement is $100/individual test, which is what companies and labs have invested in setting up. They are not incentivized to deviate from their current business plans and invest in modifying their protocols for pooling, especially with insistence from the FDA in their June 26th pooled guidance that pooled tests have sensitivities close to the gold standard PCR level.
The U.S. currently has a testing capacity of 600K/day, but because that capacity is fractured, uncoordinated, and poorly prioritized, it has been far less effective at stopping the spread than it otherwise could be. Moreover, we have not deployed pooling except in a few small instances (Nebraska). Pooling could be used to great effect to screen large metro areas or hot spot states. The costs that American society is paying for our failures in COVID testing is immense. Emergency action is overdue.
One path forward, probably the best one, is top down control of all clinical diagnostic testing, via the War Production Act. Assuming that's not likely, the best alternative is quickly building new testing capacity that is totally additive and does not cannibalize the current diagnostic supply chain. The proposed program does that.
Program Staffing and Support The sooner this program is brought online, the greater the impact. What is needed to make this happen quickly is to bring other complete teams onboard. Those teams need to have the experience and cohesion to execute on discrete chunks, and strong leadership to integrate and coordinate with the overall program. A good source of such teams is other RADX applicants, ones that are passionate about the cause and hungry for funding their teams. It is likely that many of them have the expertise needed and could be financially incentivized to pivot for a discrete time frame.
We seek assistance from other major biomedical nonprofits and research institutes, such as CZI, Gates, and the Broad, who could greatly accelerate progress. These institutions already have funding, facilities, and very knowledgeable staff. The hope is that by making the details of this program public, along with strong support from the NIH and BARDA through RADX, such groups would be galvanized into action. Those organizations alone could catalyze this plan, but collectively we can reach the goal much faster. The U.S. needs a viable plan out of this crisis, one that calls upon government, scientific, and philanthropic institutions to collaborate in the service of our return to a thriving, open society. If we act now, we can conceivably end COVID-19 in the U.S. and reopen our schools safely this Fall. This proposal, with RADX support, can achieve this goal.
### Page: Work Packages
A full description of how we are using Work Packages enable the Fast-Track program is at LINK. To speed the process, we are NOT now asking for detailed work plans - that will come later. We are just asking for the result of the work you expect to complete in discrete "Deliverables" or outputs of your work. If you are selected we will work with you to finalize plans, including access to needed resources.
To be completed in under about 4 weeks and address key implementation risks So that the chances of Work Package #2 being successful are increased.
### WP #1 Budget
1000000
### WP #1 Duration
4
### WP #1 Deliverables
Domain: Technical/Science Deliverable: Standard operating procedure of inactivation and assay protocol % of Budget: 5% Success: The SOP is a success if newly trained lab techs can routinely run it successfully after just a day of training (or few days depending on previous wet lab experience). The protocol is currently being optimized for throughput, robustness and sensitivity. Success of the SOP further means it meets the target specs of 1hr pipelined patches, < 2hr sample to answer turnaround, <5% failure rate, and < 1 copy/ul LOD.
Domain: Commercial Deliverable: Pilot mobile app for registration, sample collection, results % of Budget: 5% Success: The initial pilot app will be created on a secure and rapid, low-code development platform with a current collaborator, Appivo. Research and design have already started, including the user journey story boards and mock-up prototypes. Success involves implementing an iterative process starting with a basic app for pilot studies, obtaining valuable user feedback, and making changes as necessary. The mobile app will support a wide variety of Apple and Android devices to maximize outreach/penetration.
Domain: Regulatory Deliverable: LDT EUA submitted with clinical partner % of Budget: 10% Success: Success is meeting the criteria described in the FDA guidance for pooled SARS-COV-2 testing (July 6) and filing and LDT EUA with a clinical partner. Specifically, that is identifying a single positive sample in a pool with N-1 negative samples in 30 different pools, and also getting a negative result for 30 pools with all negative samples. Measuring a LOD capable of identifying weak positive samples, i.e. an analytical sensitivity close to the gold standard RT-PCR. Screening can being right away by the CLIA lab of the clinical partner with an accompanying LDT EUA submission.
Domain: Clinical/Workflow Deliverable: Large pilots using multiple pooling strategies % of Budget: 78% Success for the pilots involve smooth execution, devoid of hiccups such as running out of key % of Budget: 5% Success: Success for the pilots involve smooth execution, devoid of hiccups such as running out of key supplies, errors with reagents that result in scrapped samples, and problems with the website or software. Ultimately success means the participants are satisfied with the experience, and both they and us have confidence in the results they receive. Some of the pilots will be run under IRB's and we will investigate the performance at various pool levels, including 2 stage pooling for populations with very low prevalence (< 1:30,000 "green" threshold).
Domain: Commercial Deliverable: Pilot mobile app for registration, sample collection, results % of Budget: 5% Success: Success here means that independent experts have thoroughly vetted the scaling plan. The plan involves expanding lab capacity to run this assay in 3 ways: 1) utilizing existing equipment already in place in a lab, augmenting parts if necessary; 2) the installation of new equipment sets; and 3) creating an equipment loaner program for other labs to place equipment into a pool that can be accessed by those labs running this assay. Success is a clear description of those 3 ways which outsiders judge to be a viable plan.
To be completed so that the "scale-up" solutions can be deployed iby the summer and the "new" solutions by the fall of 2020.
### WP #2 Budget
10000000
### WP #2 Duration
6
### WP #2 Deliverables
Domain: Commercial Deliverable: Product App and Website % of Budget: 5% Success: The app will be further enhanced with features and additional cloud compute resources. Success means capturing customer data, ongoing sample collection data and displaying results. We will also have a sharing component which will be successful if used by 30% of participants.
Domain: Regulatory Deliverable: IVD EUA Submission % of Budget: 5% Success: The additional requirements for an IVD EUA submission will be determined and provided, such as the Fact Sheet for Healthcare Providers, Fact Sheet for Patients, and the Instructions For Use. The FDA's "Molecular Diagnostic Template for Commercial Manufacturers" will be closely followed to produce an IVD EUA submission.
Domain: Commercial Deliverable: 4M Reactions % of Budget: 50% Success: Pilot manufacturing of assay components such as the inactivation solution, binding solution, glass milk, and LAMP+primer reaction plate will already be underway. This next phase entails the scale up under good manufacturing practices. Consultants with experience in IVD manufacturing will be utilized and we will engage a CMO for the volume production runs.
Domain: Commercial Deliverable: 600 Stations Buildout % of Budget: 30% Success: Many labs will already have the necessary equipment for running this assay (pipettors, heaters, centrifuges). Regardless, we will budget for and procure all of the equipment necessary to run at the designed throughput. In additional, we'll launch an equipment donation and loaner program for biotech companies and academic labs to help the cause.
Domain: Commercial Deliverable: Training and support program % of Budget: 10% Success: A suite of training materials will be produced for all aspects of the program. These will be used by our own staff and made publicly available for groups for use in standing up their own labs, whether in the U.S. or international. Videographers, animators, and web graphic designers will create material to be incorporated into active learning, mastery based modules. 24/7 phone and web support will be put in place with experienced staff on hand to help troubleshoot problems labs may be having. Success is thousands of lab techs trained and successfully running the assay.
### Page: Resources
### Overview of Team and Environment:
The team currently consists of Randy True, Theresa Ling, and Zach Scott in collaboration with Brian Rabe and Connie Cepko at Harvard (who developed the assay) and Jeff Huber (founder of OpenCOVIDScreen). With RADX funding we will immediately expand, accreting entire other teams, taking over an entire section of the new MBC Biolabs, and seeding many parallel efforts. With support, we can roll out mass screening for the Bay Area in a week, and nationally, within a few weeks.
The situation with COVID is beyond the scope of what any of us have experienced, and I am going to make a departure from typical grant proposals to share my personal experience. When things shut down in the Bay Area in March, I thought there was an Apollo-scale project underway on both the vaccine and testing. Because I used to work in the field of molecular diagnostics, I knew that we could quickly, in a matter of weeks, adapt current ubiquitous PCR capability to test for the virus. I thought one of the key reasons we were sheltered-in-place was to do just that and identify all of the active infections, so we could cautiously resume normal life."
That would have brought the epidemic under control very quickly, and then our trajectory would more resemble that of other countries that have had better containment outcomes, such as China or South Korea or even Australia. When China saw a few dozen cases in Wuhan in May, they briefly shut the city down, tested a million people/day over a week, and eliminated the cluster before it became an, outbreak.
It is hard to grapple with the knowledge that we could have done this in March, that we already had the technology to do it, and that it didn't take some nanotechnology breakthrough. There will be time for that retrospective later, but for now, we need to focus on solving the problem at hand. We need to shift everyone's attention to doing their part in making this happen now.
Partnerships We have been in very promising discussions with multiple organizations who share our vision and desired outcomes. With RADX backing this project I believe these partners will fully lend their weight behind our effort. We will likely be starting one or more pilots shortly.
Why us? We have a fast moving startup mindset in a nonprofit structure, which allows us to be open to ask for and receive a great deal of help. Unlike a company with proprietary technology, we can and already are encouraging and enabling other groups to bring up this assay in their labs.
Although we have a small team now, we already have many pieces in place to grow and execute quickly. We can scale right away at MBC Biolabs where we have lab space. Beyond that, it will be important to scale to Bay Area military labs. The military can help us execute quickly and their Involvement and even leadership is very welcome.
There are a number of teams, companies, professors, and NGOS that are well positioned to take on such a project. However, there are no other known groups at this point who have identified this path forward. Institutional thinking and overhead for consensus can often slow down these larger groups, which is why we propose supporting our nimble nonprofit start-up effort in the
interest of maximizing speed for the public good. It is likely that larger organizations will lend support once we gain traction, and some will be able to massively accelerate the speed and size of our program as welcome collaborators and partners.
As the director of this nonprofit effort, I (Randy True) am personally forgoing a salary. I pledge to direct the spending of the money to execute as quickly as possible, and to be guided by the pursuit of the greatest positive outcomes in the effort against COVID-19 in the U.S. With a large sum of capital and the executive power to grant it, I can immediately hire capable teams with shifts to work 24hrs/day to deliver key components of the integrated system. I welcome the point that this program grows beyond what I can individually manage and is integrated into a broad national effort.
Mission Driven We are a mission driven team that feels deeply compelled to do everything we can to help in this unprecedented crisis. Building this mass screening program is an opportunity to make what will likely be the biggest humanitarian contribution of our lives. Doing this as a nonprofit aligns with our values and enables complete openness, which will be very beneficial in rallying the public behind the prioritized, need based approach.
Of paramount importance is opening schools safely in the fall. Many, if not most states, have growing outbreaks that will prevent that without a significant turnaround. Along with essential workers, we believe students and teachers are high priority groups to screen with our new program. Deploying this screening for schools will have beneficial ripple effects and is a key motivator for our hard work.
RADX funding will allow us to aggressively pursue maximizing the public health benefit of this work with the financial incentives necessary to scale our team and contract with individuals and companies to propel the work. This combination of being both practical and mission driven will be a key to the team's success in this important endeavor.
### Key Team Members
Team Member: Randy True Role on Team: Director Level of Effort: 100% Relevant Experience:
Randy True is a successful biotech entrepreneur and science generalist whose molecular diagnostics background and philanthropic efforts make him uniquely suited for driving and executing on this effort. He is the Director of Focus on Foundations, a nonprofit dedicated to improving educational outcomes through improved STEM curricula and mastery based learning.
Randy holds 2 degrees from Stanford: a Bachelors in Physics with Honors (including awards for course work, lab research and service), and a Masters in Electrical Engineering (focus on semiconductor device physics). 3 years of research at Stanford in a low temperature condensed matter physics lab building quantum electronic devices. An early career in MEMS microdevices for the semiconductor industry led a transition into BIOMEMS.
In 2005, he invented a new type of encoded silica microparticle for highly multiplexed bioassays. Randy engineered the technology from inception to be highly scalable, both in codespace and manufacturing volumes. His startup, True Materials Inc., was incubated in the first round of companies in the QB3 Garage, the original biotech incubator on the UCSF Campus at Mission Bay. Within a year, the startup grew to 5 full time employees occupying half the total lab space, had an academic collaboration on microRNA analysis, and had successfully transferred to a foundry for high volume manufacturing of the particles. True Materials was acquired by Affymetrix in 2008, where Randy became a VP of R&D, leading a 20 person team through pilot manufacturing of high throughput encoded microparticle liquid arrays.
**CV or Capability Doc LINK**
Team Member: Theresa Ling Role on Team: User experience Strategist Level of Effort: 50% Relevant Experience:
Theresa Ling is a user experience and product design Director and Strategist with experience across a wide range of industries and organizations, spanning Fortune 500 companies (Nike, L'Oreal, Walmart), new and mature startups that have gone public (New Relic, Uber), and nonprofit and arts organizations (Freelancers Union, The Metropolitan Museum of Art). She has participated in the inception and launch of multiple large scale software efforts spanning different platforms and industries, and she has a passion for human-centered design, simplifying complexity, and ecosystem-level thinking.
Key projects in her career include a global retail sales web and iOS application for Nike's Global Sales department (pilot program sales exceeded $1B), designing and launching New Relic's Infrastructure product, and devising a unifying web access strategy for Uber's many, disparate apps in advance of their IPO.
Theresa holds a BA from Barnard College, Columbia University and a Master's degree from NYU's ITP program where she was awarded a full fellowship for the duration of the program. Before transitioning to a career in UX and design, Theresa worked as a New York-based modern dancer and choreographer. She has performed and presented her own work throughout the US and internationally. Her background in the performing arts strengthens her ability to see connections between people and the programs, devices, spaces, and tools they use.
**CV or Capability Doc LINK**
### Support Requested:
Clinical validation, Access to Samples, Regulatory Commercialization Manufacturing I Supply Chain, Teaming
### resources
RADX likely has access to clinical partners who can move much faster than our current academic collaborators. RADX funding and support will almost certainly accelerate our current efforts. However given the importance of the program and previous clinical validation of the assay chemistry, it would be best to proceed in parallel with the RADX partners. In addition, regulatory expertise, especially from people with strong FDA connections, will help fast track our EUA preparation and approval. Multistep, flexible pooling and dynamic configuration of pooling levels to address different prevalences is not explicitly outlined in the EUA guidance or template. Nor is the roadmap for the adoption of no-instrument LAMP by pop-up non-CLIA labs, which are already being used in screening communities under IRB approved studies. Strategic regulatory help is needed to navigate these waters.
RADX likely has capable companies lined up for contract IVD manufacturing, and we'd appreciate engaging with them right away. The front end chemistry has been chosen to avoid supply constraints but nonetheless, supply chain expertise is essential for success of a program at this massive scale. We are aware of only one commercial source of the colorimetric RT-LAMP, New England Biolabs. Negotiating a secure supply from NEB as well as a 2nd source, are items RADX manufacturing experts can help with. Sourcing the TCEP, Nal, silica, and primers are additional supply issues where help is needed. Alternatives to these primary inactivation chemistry and silica for purification will be investigated, and again RADX expertise here would be helpful.
### Page: Submit
When all the required fields are complete, the "Primary Co-applicant can submit the application by clicking the "Save and Finalize" box in the lower right. This will bring you to any unfinished required field, or will close the form to editing and move it to a rolling screening and review step.
We will get back to the "Primary Co-applicant" as quickly as possible with the goal of less than a few days.
**Thank you for your efforts!**
### Re-submission?
# 2,061 RADx 2022 Solicitation - High-Performance COVID-19 Rapid Tests (Oct 2022).md
METADATA
last updated: 2026-03-06 by BA
file_name: RADx 2022 Solicitation - High-Performance COVID-19 Rapid Tests (Oct 2022).md
file_date: 2022-10-01
title: RADx 2022 Solicitation - High-Performance COVID-19 Rapid Tests (Oct 2022 - 5M - Not Funded)
category: various
subcategory: fl-proposals
tags:
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license: CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/
tokens: 2061
words: 1444
notes:
summary_short: The RADx Tech “High-Performance COVID-19 Rapid Tests” solicitation describes NIH/NIBIB’s fast-track program to fund next-generation OTC and point-of-care COVID-19 tests with substantially improved performance, accessibility, and digital reporting readiness. It outlines the multi-stage process (rolling review, Deep Dive, Work Packages 1–2), evaluation criteria, timeline, and application pathways for teams seeking milestone-driven support toward FDA authorization and commercialization.
CONTENT
***INTERNAL TITLE:*** Solicitation High-Performance COVID-19 Rapid Tests Fast-Track Program to Advance U.S. COVID-19 Testing Capabilities
## Overview
The RADx Coordination Center at CIMIT, on behalf of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) of the National Institutes of Health (NIH), is soliciting proposals to further advance next-generation *(next-gen)* over-the-counter (OTC) and point-of-care (POC) testing technologies for COVID-19 under its Rapid Acceleration of Diagnostics (RADx) fast-track program.
## Program Description
*Under this RADx Tech Performance solicitation, NIBIB is seeking to accelerate the development of next Next-Gen COVID-19 diagnostic technologies with a focus on performance innovations: Innovations that provide significantly improved clinical and technical performance compared to current, best-in-class OTC/POC technologies. These platforms must also integrate universal design features in order to ensure the broadest possible ease of use and accessibility for all populations. Test platforms should return results quickly, demonstrate potential for integration with digital health reporting standards, and be capable of achieving regulatory clearance during both pandemic and non-pandemic periods.*
The availability of OTC and POC COVID-19 tests has greatly assisted the nation in dealing with the SARS-CoV-2 pandemic. However, the SARS-CoV-2 virus has continued to evolve, spreading and mutating into new variants. The emergence of these variants can potentially impact test performance, depending on the type and design of the tests and the prevalence of the variants circulating in the population. Serial testing over multiple days has been recommended for tests currently on the market to maximize performance in infected populations. Further benefit could be gained from OTC/POC tests with higher performance that approaches or exceeds the level of lab-based tests.
Therefore, NIBIB is seeking to accelerate the development of Next-Gen COVID-19 diagnostic technologies with *significantly* improved performance and features compared to current widely available platforms. Tests with superior analytical, technical, and clinical performance in terms of absolute detection limits (e.g. genome copies per mL, moles of proteins), variant agnostic capabilities, and real-world clinically significant and relevant performance are needed to improve convenience, reduce time to result, and minimize if not eliminate the need for serial testing.
RADx has assembled a national network of expert technical, clinical, business, manufacturing, and regulatory advisors who will provide individualized assistance for funded projects. Funding for projects selected for this program *will be dependent* on successfully meeting aggressive project milestones. NIBIB will provide financial and in-kind support to accelerate commercialization of projects that meet milestones. To ensure that innovations are available to the public as quickly as possible, NIH will leverage established partnerships with federal agencies, such as FDA, CDC, CMS, and ASPR/BARDA, as well as commercial and private entities to propel technologies developed with RADx support toward FDA approval and widespread use.
### Submissions will follow a multi-stage process:
#### STAGE: ROLLING REVIEW
Scope of Work: Project proposals will be accepted and reviewed through the online RADx Tech portal beginning on September 20, 2022. Proposals will be reviewed by an external panel of experts for technical, clinical, regulatory, and commercialization feasibility based on the Project Review Criteria stated below. NIBIB will make the final determination about which proposals will advance to the “Deep Dive” stage for work package development based on review criteria and competitiveness of the proposal.
#### STAGE: DEEP DIVE - WORK PACKAGE DEVELOPMENT
Scope of Work: Following the Review, projects selected for further consideration by RADx Tech will be assigned a team of commercialization and subject matter experts to do a Deep Dive into the project with the applicant team. The Deep Dive will identify key risk factors that may impede the deployment of the proposed solution, as well as clear milestones that address these risks. During the Deep Dive, a group of experts will help identify additional resources needed to accelerate the project, including partnerships and/or collaborations with other applicants and/or outside organizations as appropriate. The output of the Deep Dive will be a proposal for two Work Packages (Work Package \#1 and Work Package \#2).
The proposed Work Packages will be reviewed by an external panel of experts for technical, clinical, regulatory, and commercialization feasibility based on the Project Review Criteria stated below. NIBIB will make the final determination about which proposals will advance to the Work Package implementation stage, with approved work beginning as soon as possible.
The proposed Work Packages will cover the full range of activities needed to re-risk, develop, verify, and validate the solution and to be ready for FDA regulatory review, manufacturing, and commercialization.
#### STAGE: WORK PACKAGE #1 - DE-RISKING
Scope of Work: Work Package \#1 is intended to address high-risk barriers to success which, when successfully resolved, will enable Work Package \#2 which will focus on implementation. Project teams will work to meet the established milestones, aimed toward demonstrating that the solution is feasible within an accelerated timeframe.
The RADx Tech Deep Dive team will continue to support project teams during Work Package \#1, and NIBIB and RADx Tech will provide milestone-driven financial and in-kind resources to maximally accelerate progress. NIBIB will closely monitor progress during Work Package \#1, assess milestone achievements, determine if any adjustments are warranted, and evaluate the need for continued funding based on the achievement of milestones.
#### STAGE: WORK PACKAGE \#2 - IMPLEMENTATION
Scope of Work: Work Package \#2 will cover the full range of activities needed to be ready for FDA regulatory authorization, manufacturing, and commercialization. Funding for Work Package \#2 will be contingent on meeting the milestones of Work Package \#1, having a well-resourced commercialization plan, and the market competitiveness of the solution as assessed by the NIBIB.
The RADx Tech Deep Dive team will continue to support project teams during Work Package \#2, and NIBIB and RADx Tech will provide milestone-driven financial and in-kind resources to maximally accelerate progress. NIBIB will closely monitor progress during Work Package \#2, assess milestone achievements, determine if any adjustments are warranted, and evaluate the need for continued funding.
Budgets for this phase of the work are expected to be substantial. NIBIB will supply funding, partnerships, and in-kind resources needed for the solution to be ready for regulatory authorization, manufacturing, and commercialization. NIBIB will negotiate cost sharing with for-profit institutions as appropriate.
## Project Review Criteria
Each application will be reviewed by an independent external expert panel. All applications must:
- Clearly describe how the proposed technology will *significantly* improve clinical and technical performance compared to current, best-in-class OTC/POC technologies.
- Integrate universal design features for the broadest possible ease-of-use and accessibility for all populations
Applications must provide details on how performance in terms of absolute detection limits (e.g. genome copies per mL, moles of proteins), variant agnostic capabilities, and real-world clinically significant and relevant results will be accomplished and verified.
Additional factors that should be addressed and will be considered:
- Time to commercialization readiness and ability to meet regulatory requirements for intended use (OTC and/or POC): submissions for EUA within 24 to 36 months and standard clearance within 24 months
- Innovations that can potentially reduce manufacturing costs and retail prices, facilitate rapid scale-up during surge demands, and improve supply chain resilience
- Support for digital health platforms including ability to communicate results to appropriate healthcare providers and, as appropriate or required, public health authorities
- Ability to work with/adapt to rapidly changing variants and be multiplexed and/or adapted for multiple pathogens/diseases
- Experience, resources, and commitment of the team and applicant organization
## Timeline
There will be a rolling submission and selection period beginning on September 20, 2022 that is currently planned to continue until October 14, 2022.
## Award Information
Proposals submitted to RADx Tech will be reviewed rapidly as applications are received (see Project Review Criteria). Based on meritorious review, RADx Tech will select projects for a multi-phase process described above. Each phase will have a separate funded budget and deliverables that must be reached to move to the next phase. Successful completion of a phase does not guarantee funding for the next phase as this is a competitive program with limited funds.
Awards are milestone-based and selected teams must work collaboratively with assigned RADx experts and associated web-based tools, including the CIMIT's [GAITS platform](http://gaits.org/) to continue. Full Federal overhead rates apply.
## How to Apply
Applicants may [preview the application content here](https://www.poctrn.org/documents/461099/0/RADx+Tech+High+Performance+Application+Preview.docx/69468216-16f7-87f4-9d41-57bca460ad43?t=1663685182706).
To submit an application you can:
1. [Use our online submission tool](https://colab.secure-platform.com/a/solicitations/111/home).
2. Download our [accessible Excel application form](https://www.poctrn.org/documents/461099/0/RADx+Tech+High+Performance+Application+Form.xlsx/cc2f815c-00a8-cc65-4815-e006f8f7a983?t=1663683708373) for an application with enhanced accessibility.
More detailed instructions are provided in the online submission tool and the Excel application form. For additional accessibility assistance or questions please email info.radx@poctrn.org.
Please do not send applications to this address.
## Frequently Asked Questions
If you have questions please visit our [Frequently Asked Questions page](https://www.poctrn.org/web/radx-tech-high-performance-tests/faqs).
For other programmatic or technical questions please contact info.radx@poctrn.org.
# 7,818 RADx 2022 Submitted Proposal - FloodLAMP (Oct 2022 - 3M - Not Funded).md
METADATA
last updated: 2026-03-06 by BA
file_name: RADx 2022 Submitted Proposal - FloodLAMP (Oct 2022 - 3M - Not Funded).md
file_date: 2022-10-31
title: RADx 2022 Submitted Proposal - FloodLAMP (Oct 2022 - 3M - Not Funded)
category: various
subcategory: fl-proposals
tags:
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xfile_type: docx
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license: CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/
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notes:
summary_short: The FloodLAMP RADx submission outlines a next-generation, low-cost LAMP-based screening platform pairing reagent-in-cap test devices with modular heater/reader instruments and an integrated mobile app/admin portal for pooled, decentralized testing programs. It summarizes pilot experience (~35,000 samples across 11 surveillance deployments), projected performance and costs, and an open-source business model built around disclosed chemistry, Rights of Reference, and broad licensing for interoperability. It also proposes a two-phase RADx work plan to prototype devices/instruments, run multi-site clinical studies, pursue EUA/510(k) pathways, and scale manufacturing and digital infrastructure for pandemic-ready screening.
CONTENT
***INTERNAL TITLE:*** FloodLAMP RADx Submission 10-31-2022
[https://www.poctrn.org/web/radx-tech-high-performance-tests](https://www.poctrn.org/web/radx-tech-high-performance-tests)
## Abstract (50)
*Please provide a brief description of the problem and solution being addressed*
Recent advances in diagnostics are not yet configured for population-level pandemic response. Despite large amounts of COVID-19 response funding in the space, the market for true pandemic screening products and services remains highly unstable. We propose a durable next generation molecular platform with isothermal test devices and flexible heater-reader designs.
## Solution Summary (200)
*Provide a brief solution overview*
FloodLAMP’s new platform combines key innovations in diagnostic testing technology and modalities that have matured during the COVID-19 pandemic: isothermal amplification (LAMP), direct extraction-free assays, and sample pooling. Our new test device comprises a reagent-containing cap that is coupled to a standard collection tube. The tube is inserted into a compact instrument that both heats and reads the assay signal optically, wirelessly transmitting results for walkaway operation. Heating and reading subunits of the instrument are decoupled to leverage low cost, high volume manufacturing of PCB’s and standard dry bath heaters. The heater-reader versions comprise one for a single device and anotherst version accepting up to 60 asynchronously. We’re also planning a device version with visual readout.
The new device and instrument are combined with program components optimized over the last 16 months in 11 LAMP surveillance pilots. We’ve developed self-pooled collection kits, registered on-the-fly with our mobile app which is integrated with onboarding and program administration tools.
We are innovating in a third domain, using a public benefit corporate structure and open source business model. We have committed to fully disclosing the test chemistry and primer sequences in all of our FDA submissions, granting ROR’s, and widely licensing for interoperability.
## Technical Characteristics (200)
*Briefly describe technical characteristics of the solution including how clinical performance approaching PCR levels is achieved*
Our new test system is anticipated to have an LOD and clinical sensitivity in the range of other COVID-19 EUA tests that use similar LAMP chemistry. We use 3 primer sets (18 oligos) combined in one reaction. These primers have demonstrated good performance in a clinical study by Stanford (March 2021), in silico, and importantly in extensive real world testing (~35,000 samples at 10 sites).
The per sample cost is anticipated to be approximately \$1, based on current all-in test kit COGS <\$.50 (collection kit, consumables, reagents - for pool of 4). The device design uses a reduced reaction volume to the 10-50 uL range, minimizing the enzymes needed which are the cost driver. The single instrument is expected to cost $50-100, and the 60-wide version, ~$1000.
For the POC/PON intended use, throughput is important and a primary design consideration. We’ve modeled the hands-on time to be 12 seconds per tube, and anticipate ~30 minute total turnaround time. The instrument runs asynchronously, with results transmitted wirelessly. Thus, one operator can process ~1,000 samples per hour (average pool size 3). The ease of use of the system means minimal training is needed for the POC operator.
## Key Performance Parameters
**Sensitivity (This is a required field).**
88-96% (anticipated, based on comparables and FloodLAMP's QuickColor COVID-19 LAMP test performance in real world and clinical study)
**Specificity (This is a required field).**
98-100% (anticipated, based on comparables and FloodLAMP's QuickColor COVID-19 test performance in real world and clinical study)
**Level of detection (This is a required field).**
300 - 3,000 copies per swab (anticipated, based on comparables and FloodLAMP's QuickColor COVID-19 test performance in real world and clinical study)
**Time to run a single test (This is a required field).**
30 minutes (anticipated, based on comparables and FloodLAMP's QuickColor COVID-19 test)
**Production cost of the test (This is a required field).**
$3-5 individual sample, $0.80-1.25 per sample with pool of 4 (anticipated)
**Production cost of the instrument (put n/a if not applicable) (This is a required field).**
$1,000 for 60-sample version, $50 single sample version (anticipated)
## Prior Work and Current Status (750)
*Describe the current status of your proposed solution and any additional information you would like reviewers to consider. (750 words or less)*
FloodLAMP has run 11 end-to-end COVID-19 surveillance screening pilots using our current extraction-free LAMP test and other program components, with ~35,000 samples tested. We supported many of these programs through the 2021/22 Omicron surge, including three EMS departments, two 1,000 person municipal workforces, and a preschool that used at-home pooled sample collection. The inspiration and design objectives of the new platform are drawn directly from the experience and lessons learned from implementing these pilot surveillance screening programs over the last 2 years.
Pilots stats:
- 11 programs, 10 sites in 5 states, from Dec 2020 to present;
- 35,184 samples tested total; 15,748 pools; 3,587 individuals tested;
- 550 positive samples;
- 23 test operators trained, majority with no prior experience;
- 483 users collecting with our mobile app.
The FloodLAMP Mobile App and Admin Web Portal were launched in the spring of 2021 and are available in the Apple and Google app stores. All but one of our surveillance pilots have used them. They were designed as a holistic digital suite for decentralized, organization and community based disease screening. The app has 3 interfaces, 1) for participants to manage their profile, collect pooled samples, and view test status; 2) for testing staff to intake, track, and result tubes; and 3) for program administrators to onboard users, manage permissions, and view results. A novel capability is the self-registration of participants in pooled sample collections. We filed broad IP in this area in 2020 (published application US20220208394A1), and received a favorable written opinion from the USPTO on our PCT, enabling prioritized examination of our regular US patent application. We filed a followup provisional patent covering additional inventions on digital components of screening programs.
The new test devices and reader instrument work is currently at the design stage. We seek RADx support to build initial prototypes, and also to carry out clinical studies on other components of the test system. These include the OTC pooled collection kit and our mobile app. FloodLAMP has filed a 161 page provisional patent, broadly covering many embodiments of the new platform components, systems, and methods.
Our pilots provided critical feedback in improving our program components. Several program administrators commented that once they had their “lab” set up and were comfortable running the test, the logistics of coordinating sample collection and transfer was far more work. Both of our EMS+municipal workforce programs used a hub and spoke model, with 7-10 sites around the city where samples were aggregated then shuttled 5-30 minutes away to the single processing site. With the flexibility of both single and many device instruments, our new platform can span a range of volumes of screening at different levels of decentralization. We see the organizational based, point-of-need modality as important for workplaces and schools, especially during surges. We’re planning to enable both individual/single household at-home and POC/PON screening with the same platform.
Overall in the space, we see the need for a fully vertically integrated company to hit the low price need for pandemic screening, which needs to both rapidly scale and maintain readiness. We commercialized our in-house surveillance at the price point of $5 per pool ($1.25 per sample). The COGS are $1.93 per pool at the 1M scale, including the collection kit, reagents, all consumables, and digital license. FloodLAMP provided all of the materials, training, and support to bring up the in-house pilot programs. Our service pilots were the white-glove model. We intend to offer the same end-to-end programs built around our new platform, while at the same time extensively partnering and licensing.
During the pandemic, we have been involved with many projects and groups and made a number of connections that will bring support during our next stage. These include: the executive leadership at New Englands Biolabs (see below), the global LAMP consortium and Professor Chris Mason of Cornell Weill, Anne Wyllie (Yale, Saliva Direct), Jeff Huber (Grail, Open COVID Screen), Simon Johnson (MIT, MA testing), Robby Sikka and the Sports and Society Working Group, Taylor Sexton (Todd Strategy Group, formerly ASPR).
Our focus to date has been in building and piloting screening programs that have the characteristics needed for resilient, decentralized pandemic preparedness and response. With the filing of IP on this next generation platform and upcoming publication of our work, we are transitioning to fundraising and outreach. We are eager to engage with RADx and hope our work may be of help in a national and global pandemic testing strategy.
## Regulatory Status (200)
*Provide an overview of regulatory status (FDA and CLIA approvals) (200 words or less)*
FloodLAMP has filed a Pre-EUA on our pooled self-collection kit + mobile app, and 2 full EUA submissions, as “open source protocol” tests, the most recent in October 2021. We received written feedback and had a conference call, attended by myself, Anne Wyllie of SalivaDIrect (a close advisor to FloodLAMP), several reviewers, and Kris Roth from the FDA. The FDA declined to continue our review, it’s our understanding due to FloodLAMP not being a large manufacturer or experienced developer. We have concluded based on the FDA November 2021 guidance that agency support is required for further engagement or review by the FDA.
Submission information:
PEUA210313 FloodLAMP Pooled Swab Collection Kit DTC
EUA210581 FloodLAMP EasyPCR COVID-19 Test
EUA210582 FloodLAMP QuickColor COVID-19 Test
We have an active IRB protocol (WCG 20210401) for 3 variations of prospective clinical studies of asymptomatic subjects, including user factors regarding the collection kit and mobile app.
We have implemented initial modules of an ISO 13485 compliant QMS system, supported by consultants at Rook Quality Systems. We have also contracted with regulatory consultants at Arete Biosciences in support of our EUA submissions and IRB.
We have not undertaken steps toward regulatory approval for our new platform.
## Performance Testing (200)
*Provide an overview of performance testing done to date (200 words or less)*
The performance testing done to date has been with the moderate complexity, pipet based version of our colorimetric LAMP assay. We expect the technical performance of the new platform to meet or exceed that of our current test system, while greatly improving the usability and reducing contamination concerns. Our new platform will likely use the same 3 primer sets as our current test, with similar LAMP reaction chemistry.
A clinical evaluation of our direct PCR and colorimetric LAMP tests was completed on March 10, 2021 by the Stanford Clinical lab, in preparation for our first EUA submissions. A summary of analytical and clinical results follow:
Direct Colorimetric LAMP:
- analytical LOD: 12,000 copies/mL;
- no cross reactivity;
- expected results on interfering substances;
- 90% clinical sensitivity (PPA 36/40);
- 100% specificity (40/40);
- no false positives;
- missed positives only high Ct (>36 with PCR).
Direct PCR:
- analytical LOD: 3,000 copies/mL;
- 98% clinical sensitivity (PPA 39/40);
- 100% specificity (40/40);
- no false positives.
The real world performance of our surveillance LAMP test has been excellent, robustly identifying new infections early. That will improve with the convenience and portability of the new platform, thus reducing barriers to routine testing.
## Implementation and Production (200)
*Provide a summary of your implementation and production plans (including projected monthly production capacity) (200 words or less)*
FloodLAMP’s implementation plans include initiating prototype development for the new device and instrument (see Work Package #1). Simultaneously we will execute on 2 sets of deliverables that can both have independent impact in the field and are on the critical path of the overall plan of developing pandemic screening using the new platform. The first is gaining EUA for the OTC pooled collection kit and app, which we plan to broadly license and partner around. The second is assay work to translate our current test to POC format, comprising lyophilizing our current test, optimizing a 1-step chemistry, sourcing single reaction dispensers of the inactivation solution, and a dropper cap. These steps bridge to our new platform and offer significant workflow improvements that may themselves warrant scale up.
Regarding production, we will utilize multiple suppliers and manufacturers and partner for US and global distribution, starting with companies with which we have existing relationships. We completed an order from LGC for a 1.2M reactions of our primer sets and are working with the OEM team at NEB.
Post COVID-19, we will source primers and assay technology IP from academic labs, offering a commercialization model that facilitates scale through open access.
## Other Information (750)
*Provide other relevant information including handling variants, accessibility for individuals with disabilities, support for telemedicine and communications of results, platform and/or multiplexing capabilities, avoidance of common supply chain issues, addressing unmet needs of traditionally underserved and underprivliged populations, and scalability of production.*
### Multiplexing
Some new device designs incorporate multiple reaction chambers to multiplex targets. Additionally, some device designs utilize swappable reaction components to enable different pathogens to be tested from the same sample tube. Multicolor detection by the instrument is also possible but adds complexity and cost.
### Variants
Our current LAMP test and primers are very robust to variants. We use 3 primer sets (18 oligos) all combined in the same reaction. The primers comprise 2 open sets (N2, E1) and 1 proprietary set “Rabe-Cepko AS1e” (ORF1ab). We used the NEB Primer Monitoring for our Evaluation of Impact of Viral Mutations section of our October 2021 EUA Submission. Further, NEB completed a large, comprehensive wet study earlier this year of the effect of mutations in our same 3 primer sets, finding “no effect on detection sensitivity at positions equivalent to those that significantly impact RT-qPCR assays.” FloodLAMP has an option to the exclusive license on Rabe-Cepko IP and is in late stage license negotiations with Harvard Medical School.
These 3 primers have performed well in real world surveillance programs and our Stanford clinical study, offering high sensitivity and a low false positivity rate. Over 500 positive samples have been detected and confirmed, the vast majority Omicron variants.
### Accessibility
The core of our new platform is ease of use, which in turn enables accessibility and scale. We have minimized the number of steps and components in the new test workflows. All actions of manipulating the consumables require low physical effort and have a high tolerance for error with no lab training necessary. We will provide alternative instruction materials in accordance with ADA guidelines in order to make them accessible to those with visual, audio, or other impairments.
### Telemedicine Support
We have an API to our digital platform that can automate all required federal, state and local reporting requirements, as well as interface to any 3rd party digital health platform or EMR system.
### Supply Chain
A key aspect of the primary device designs is that they utilize standard sample tubes, allowing us to leverage existing supplies and manufacturing capacity. The main instrument design also leverages existing systems, using a drop-in replacement of a standard sized dry block that is inserted into dry bath heaters.
### Production Scalability
The device design is relatively simple, facilitating large-scale production of the plastic cap units. An advantage is the enablement of distributed 2nd stage manufacturing of the reagent component, through a 2 part design that can be loaded by pipette, or at various production scales using liquid handlers. The low cost plastic components of the consumable device can be supplied to testing centers in LMICs as prepositioned assets to reduce supply chain risk during health emergencies. It also supports redundant domestic manufacturing.
U.S. based reagent manufacturing is anticipated to use lyophilization. FloodLAMP is thankful to New England Biolabs, one of the largest enzyme producers globally, with whom we have a close relationship and multiple collaborations on community testing, including early childcare screening in the U.S., and 2 with universities in South America. We have had multiple meetings with the leadership team of NEB, which is also a Public Benefit Corporation, and they have provided us with a letter of support for federal funding that includes early access and recommendations, specifically for lyophilized formats.
### Underserved Populations
Our new platform addresses underserved populations through the combination of low cost and scalability. A primary motivation for the new platform, and FloodLAMP’s work in general, has been to translate the on-demand rapid molecular programs enjoyed by sports and entertainment to the rest of society. It’s important that underprivileged communities have access to reliable tests for screening, which currently means molecular. One day in December 2021, our Coral Springs program had 22 positives in one run. They reran the plate, getting the same results. Per protocol, all LAMP positives were immediately tested with BinaXNow. Only 1 came back antigen positive. This caused some of the positive firefighters, paramedics, and police officers to question the LAMP test. Over the next few days of serial testing, all 22 turned antigen positive. Doubt in the reliability of antigen tests has been cited in studies as a primary reason for not participating in free screening programs.
We see the potential for innovation on incentives to drive adoption in underserved communities, and we hope to work in this area as well in the future. Further advances in ease of use and cost, along with digital and program integration, are needed first to provide the foundational decentralized screening capacity.
*We are not now asking for detailed work plans - that will come later.*
*Describe the result of the work you expect to complete in discrete "Deliverables" or outputs of your work. If you are selected we will work with you to finalize plans, including access to needed resources.*
***Work Package #1 is intended to address high-risk barriers to success which, when successfully resolved, will enable Work Package #2 which will focus on implementation***
## Work Package #1 (200)
*Budget – Please indicate your expected direct budget (including labor and all expenses with full Federal OH rates) – Short answer*
*Duration – What is the expected duration of WP #1 (in weeks) – Short answer*
*Deliverables (200 words or less)*
Budget - $3M
Duration - 16 weeks
Deliverables:
We first propose to publish the results of our EMS and school pilots, with feedback and support from the RADx team.
To de-risk key elements of the new platform, we propose the following deliverables:
1. Prototypes of new device designs and instrument:
a. devices built at Stanford Nanofabrication Lab and CRO;
b. instrument design and build (subcontract).
2. Large scale, multi-site clinical studies:
a. for OTC pooled collection kit and FloodLAMP Mobile App;
b. for 2 moderate complexity tests - direct LAMP and PCR;
c. leverages current surveillance program infrastructure;
d. uses enrichment strategy in surveillance population and site/household exposure;
e. daily serial testing to evaluate performance in identifying new infections;
f. comparison against both antigen tests and high sensitivity lab PCR;
g. single site fast-tracked for EUA’s;
h. expansion to multiple sites for 510K data collection;
i. sites primed for clinical studies using new platform prototypes;
j. proposal for adjunct funding (RADx-UP) for saturation screening in 10,000+ person population (endpoint outcomes: disease burden reduction, staff/student outage, and adoption rate, comparing different incentives).
3. FDA EUA submissions for tests, pooled collection kit, and app.
4. Bridge assay development.
5. Manufacturing partnerships:
a. NEB, LGC, Twist, and CMO;
b. manufacturing and kitting of 1st 800,000 LAMP test kits.
6. Fully integrated digital suite for program execution and management.
## Work Package #2 (200)
*Budget – Please indicate your expected direct budget (including labor and all expenses with full Federal OH rates) – Short answer*
*Duration – What is the expected duration of WP #2 (in weeks) – Short answer*
*Deliverables (200 words or less)*
Budget - $20M
Duration - 76 weeks
Deliverables
The following deliverables form the core of the operational aspects of commercialization, including FDA full market approval. Business deliverables will be funded from additional sources and are excluded below.
1. 510K approvals for all components of new platform and current moderate complexity tests:
1. completion of optimized devices, including both visually read and instrument read versions;
2. multi-site clinical studies with the new platform;
2. Pilot manufacturing run of new platform consumables, including cap components and loaded reagents.
1. implementation of full ISO13485 QMS system.
3. Completion of commercialization-ready instrument:
1. one or more manufacturing partners identified and supply agreements negotiated.
4. Full suite of commercialized digital tools:
1. program Admin Web Portal;
2. participant Web Portal (onboarding and communications);
3. FloodLAMP Mobile App (native and web app versions);
4. infrastructure upgrades to support scale.
## Overview of Team and Environment (200)
*Please provide an overview of the team members and why they collectively have the expertise and access to resources to be successful in achieving a deployable solution. (200 words or less)*
Our core team has a successful track record of technology innovation in assay platforms, microfabrication, fluidics, and molecular biology with applications in diagnostics. We’ve demonstrated the ability to carry research and development projects forward into production as exemplified by Randy and Gary’s work at Affymetrix.
We have expertise in design and execution of clinical studies through our medical advisor, Dr. Peter Antevy who is experienced in clinical study protocol design and recruitment.
We also have deep expertise in digital design and user experience, both on our team and in our network.
Our extended team of investors and advisors include individuals in diagnostics, biotech finance, venture capital, academic research, and clinical medicine.
Anne Wiley, founder of SalivaDirect and pioneer of the first open source protocol EUA, is on our Scientific Advisory Board, as well as being a friend and mentor on all FDA matters.
Being based in Silicon Valley and 10 minutes from Stanford University, FloodLAMP is in a prime location physically and in our development to bring human and financial resources to bear on the problem of pandemic-level disease screening.
## Team Member - Randy (200)
Team Member Name – Randy True
Role on Team – Founder and CEO
Level of Effort – 100%
### Relevant Experience
Randy brings a broad background in science, engineering, and management to the company, as well as specialized experience in molecular detection technology, including DNA and RNA bioassay development and microfabrication. His particular strengths are in innovation and integration, drawing on engineering skills spanning hardware, software, and materials. He has led the rapid execution of multidisciplinary projects, design at scale, and successfully transfer processes to high volume manufacturing facilities. Randy is the inventor of ten issued US patents.
Randy has been an advisor and consultant across many industries. In 2018, he founded Focus on Foundations, a science education 501(c)3 non-profit whose mission is to develop innovative, impactful STEM curricula by connecting hands-on learning and practical skills with deep theoretical knowledge.
Randy has a B.S. in Physics and M.S. in Electrical Engineering from Stanford University. While at Stanford, he did research on quantum electronic devices, training at the Stanford Nanofabrication Facility. He worked in startups and the semiconductor industry, and as a microfabrication consultant at the Stanford Nanofab for 10+ years. This extensive experience in rapid iteration on designing, building, and testing microdevices is well suited to development of the new platform.
### Current or most recent position - Include start and end dates, title and position description
FloodLAMP Biotechnologies, PBC
August 2020 - present, Founder and CEO
As FloodLAMP’s CEO, Randy is responsible for the key executive functions of fundraising and recruiting. He also leads the regulatory and communications strategy. Being a startup, Randy also contributes to engineering and design, as well as overseeing the company’s training program and quality system.
### Past position #1 - Include start and end dates, title and position description
True Materials Inc. and Affymetrix
December 2005 - 2010, Founder and CEO, VP R&D
Randy previously founded the biotech startup True Materials, Inc., which developed a barcoded microparticle technology with a variety of applications including particle-based DNA microarrays for genetic analysis and molecular diagnostics. Randy built the microparticle prototypes at the Stanford Nanofabrication Facility and successfully transferred production to a high volume semiconductor foundry. True Materials was incubated in the first cohort of companies at UCSF/QB3 Garage at Mission Bay.
True Materials was acquired by Affymetrix in 2008 where Randy served as VP of R&D, Liquid Arrays. He built and managed an interdisciplinary team of 20 that brought the technology to pilot production, prior to the Affymetrix sale to Thermo Fisher.
### Past position #2 - Include start and end dates, title and position description
Shaper Tools, Inc
January 2016 - January 2018, Technical and Business Advisor
Technical consulting, fundraising, and patent strategy.
## Team Member - Gary (200)
Team Member Name – Gary Withey
Role on Team – VP of R&D
Level of Effort – Full-time
### Relevant Experience (up to 200 words)
Gary brings fifteen years of industrial biotech experience in technology development, invention, process development, and product development. He has broad expertise spanning diagnostic platforms, therapeutic discovery platforms, microfluidics, semiconductor microfabrication, rapid prototyping, automated liquid handling, molecular biology, and data science. He is the inventor of three U.S. patents and two patent applications in the fields of microfluidics, diagnostics, molecular biology, and single-cell sequencing.
In his work at Atreca and Gigagen, Gary has designed and constructed droplet microfluidic devices and associated emulsion chemistry and molecular biology for high throughput single cell screening and analysis. This work included rapid prototyping via 3D printing and CNC machining of custom components and extensive design and execution of experiments to optimize droplet stability and performance of biomolecular assays on single cells. He also performed downstream bioinformatic analysis of large single cell sequencing datasets.
At Affymetrix, he developed a process to produce DNA-labeled, barcoded microparticles for highly customizable, low-to-mid-plex, particle-based DNA microarrays for genetic and transcriptomic applications in diagnostics and research. He served as company liaison at a semiconductor microfabrication core to produce barcoded microparticles. He designed and managed a pilot production facility to conjugate particles to synthetic DNA via high throughput, automated liquid handling.
### Current or most recent position - Include start and end dates, title and position description (198)
FloodLAMP Biotechnologies, PBC
Nov 2020 - present, VP of R&D
Gary has helped to adapt and optimize the current extraction-free colorimetric LAMP assay that is the workhorse of our disease screening programs. He devised many of FloodLAMP’s custom reagent formulations and created the system for their production and quality control that has over time evolved into a mature quality management system. He integrated robot liquid handling to scale reagent preparation and kitting capacity of FloodLAMP reagents. He has rapidly prototyped and produced custom labware components such as tube racks for which there exist no suitable standard products. He has designed and implemented systems for inventory control, lab operations and decontamination procedures, and project management.
Gary has played a key role in overseeing the initiation and ongoing operational support of multiple of FloodLAMP’s surveillance testing deployments, including training and knowledge transfer, transfer of materials and inventory management, lab setup, technical troubleshooting in the laboratory and digital spaces, and support related to data management and program management.
Gary also led the IP effort for our new platform technology, contributing many of the core design aspects of the consumable cap and the heater/reader instrument to our provisional patent application.
### Past position #1 - Include start and end dates, title and position description (123)
Atreca, Inc
July 2013 - March 2022, Associate Director of Engineering, Head of Engineering
Gary’s responsibilities included the construction of a microfluidic system for high-throughput single-cell transcriptome analysis. This involved fabrication of custom microfluidic components through collaboration with external partners as well as hands-on fabrication of device components using CNC machining, laser cutters, 3D printers, milling machines, and other standard workshop equipment. He performed extensive studies to optimize complex emulsion-based RT-PCR reactions to enable a phage display technology built on this microfluidic system for the discovery of promising antibodies for immuno-oncological therapeutics. Gary also performed bioinformatic analysis and protein engineering based on sequencing pipeline data in order to optimize antibody synthesis yield. He developed IP that led to three issued patents and one patent application.
### Past position #2 - Include start and end dates, title and position description (108)
GigaGen, Inc
March 2011 - July 2013, Director of Engineering
Gary designed and assembled microfluidic chips and custom hardware into a system for high-throughput genetic analysis of single cells. His design work included rapid prototyping of microfluidic chip designs in PDMS before then translating design features into glass chips. He performed studies to optimize oil/surfactant formulations for both thermostability and compatibility with emulsion PCR in the presence of cell lysate. He also performed studies to optimize emulsion based RT-PCR for next-gen sequencing library preparation. He also developed software for device control of system components. Gary also contributed to IP development in microfluidic chip design and single-cell sequencing applications.
## Team Member - Theresa (200)
Team Member Name – Theresa Ling
Role on Team – Lead, Design and Program Experience
Level of Effort – Part-time
### Relevant Experience
Theresa Ling is a Product and Experience Design professional seasoned in creating systems and tools for complex information and interactions. Her work has spanned projects for Fortune 500 companies, startups, and nonprofit organizations, and she has participated in the inception and launch of multiple large scale software efforts spanning different platforms and industries. Notable projects prior to joining FloodLAMP include creating a new sales platform for Nike’s Global Sales department (pilot program sales exceeded $1B), designing and launching New Relic’s Infrastructure product, and devising a unifying web access strategy for Uber’s many, disparate apps in advance of their IPO. Before transitioning to design, Theresa worked in the performing arts as a dancer and choreographer. This background informs her human-centered design approach and strengthens her ability to see the connections between people and the programs, spaces, and tools they use.
### Current or most recent position - Include start and end dates, title and position description
FloodLAMP Biotechnologies, PBC
August 2020 - present, Program Experience and Design
Theresa has contributed extensively to the user experience of FloodLAMP’s testing program. This includes product design for the digital tool set (app, most web tools), site and population considerations with respect to usability and collection challenges, and developing outbound communications for participating organizations and test subjects (i.e. collection kit instructions, signage, program overviews). She acted as Program Manager for FloodLAMP’s first preschool pilot with at-home family pooling, managing all communications, site planning and scheduling with an eye toward reducing the friction and pain points associated with COVID testing for busy families.
Theresa has integrated user feedback into ongoing improvements in the app design, including streamlining the core participant flow and updating interaction patterns for the staff user, and continued to design new tools for program registration. Theresa additionally manages the company website and communications, and will be leading the user experience and design of the new platform. Theresa also contributed to the IP effort for FloodLAMP’s digital tools featuring pooled self-collection as well as the followup provisional application covering additional inventions on digital components of screening programs.
### Past position #1 - Include start and end dates, title and position description
Uber
November 2017 - May 2019, UX Lead
Hybrid IC/manager managing several designers within the web team as well as leading key design initiatives. Key projects include leading the creation of web design system templates for Uber’s international operations workforce, and designing and planning a new web portal experience to unify a fragmented app ecosystem prior to IPO.
### Past position #2 - Include start and end dates, title and position description
New Relic
February 2016 - June 2017, Senior Product Designer
Principal designer for the new Infrastructure product working in an agile framework. Established design system for new product within an existing product suite, conducted all user research on Beta and synthesized findings into design updates per sprint, worked in step with engineering team to ensure design to spec, supported product launch and advised on roadmap.
## Team Member - Peter (200)
Team Member Name – Dr. Peter Antevy
Role on Team – Medical Director
Level of Effort – Part-time
Relevant Experience (up to 200 words)
Dr. Antevy is a Pediatric Emergency Medicine Physician at Joe DiMaggio Children’s Hospital in South Florida and the Founder & CMO of Handtevy Pediatric Emergency Standards Inc. He serves as the Medical Director for Coral Springs Fire Department, Davie Fire-Rescue, Southwest Ranches Fire Rescue and American Ambulance, and is the Associate Medical Director for several other agencies. He is also a longstanding medical director for two paramedic training programs and several mobile integrated healthcare (MIH) programs. Dr. Antevy has authored studies and spearheaded a system used to expedite resuscitative care for children. He is involved in his departments’ continuous quality improvement (CQI) programs and has seen dramatic improvements in the outcomes of cardiac arrest patients. This year, he helped bring the Seattle Resuscitation Academy to Florida and has demonstrated a significant impact on prehospital cardiac arrest outcomes.
### Current or most recent position - Include start and end dates, title and position description
FloodLAMP Biotechnologies, PBC
December 2021 - present, Medical Director
Peter serves as FloodLAMP’s Medical Director, where he has been instrumental in building both the relationships and program protocols to make FloodLAMP’s EMS COVID-19 surveillance programs successful. As a nationally recognized leader in EMS, Peter provides important connections to EMS departments at state and regional levels. In addition, he advises on testing procedures, communications, and clinical studies.
### Past position #1 - Include start and end dates, title and position description
Handtevy - Pediatric Emergency Standards, Inc
January 2010 - present, Founder & Chief Medical Officer
Peter founded Handtevy with the mission to improve pediatric resuscitation and reduce medical errors in EMS Agencies and Emergency Departments around the country. Handtevy is succeeding in this mission with programs in all 50 states. The Handtevy product is a simple and responsive web based system that can intake patient information and rapidly develop a treatment plan, allowing EMS personnel to act precisely and effectively. Patient data is properly stored according to HIPPA regulations and all resuscitative actions are completely documented automatically. The emphasis on user experience on all platforms reduces the chance of mis inputs or misuse, increasing rates of correct pediatric dosing to over 85%.
Peter founded and built Handtevy from the ground up. He currently serves as Handtevy’s Chief Medical Director, managing key staff as well as leading high level outreach to state health departments and other stakeholders.
### Past position #2 - Include start and end dates, title and position description
C3MD, LLC
December 2014 - Present, President
Peter is Principal and President of 3CMD, which is engaged in various medical business activities. 3CMD is a provider of the EcoTest COVID-19 IgG/IgM Rapid Test Device - an in-vitro immunoassay for the direct and qualitative detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum or plasma.