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last updated: 2026-03-06 by BA
file_name: Quad Chart v1 - FloodLAMP (Dec 2021).md
file_date: 2021-12-30
title: Quad Chart v1 - FloodLAMP (Dec 2021)
category: various
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summary_short: The FloodLAMP Rapid Response Molecular Screening Network brief outlines a plan to scale a distributed network of low-cost, instrument-free molecular surveillance sites using the QuickColor LAMP test and a mobile app/LIMS for pooled collection, tracking, and reporting. It summarizes current deployments and reported performance, then defines milestones for rapidly bringing up local screening sites, securing “open source protocol” EUAs (including a pooled home collection kit and app), and expanding resources, supply chain, and training/QMS to enable multi-million–test deployment.


CONTENT

FloodLAMP Rapid Response Molecular Screening Network 
Randy True (randy@floodlamp.bio), FloodLAMP Biotechnologies, PBC


## Upper Left Quadrant
### Objective:
FloodLAMP's mission is to improve global health and resiliency through universal access to rapid molecular testing. We have developed a key capability that can help realize the enormous potential of the field of diagnostics in ending this pandemic, preparing for the next one, and improving human health globally. Our near term objective is to deploy hundreds of sites delivering easy to use, flexible, fast turnaround COVID surveillance screening to drive durable adoption in the communities most in need. 

### Description of effort:
- Fully integrated turnkey surveillance programs comprising all equipment, consumables, test kits, pooled collection kits, digital tools, training, and support;
- Systems cost of $2K gives 20K/day capacity, at low cost of <$2 pp (incl labor);
- Currently 8 systems deployed with EMS departments in 3 states, 11 staff trained to run test (5 with no experience), 5,600 people screened, 36 unknown positive cases detected, 44 known confirmed (100%), no known FN;
- Full FDA EUAs submitted for 2 tests, duplex PCR and colorimetric LAMP, as open source protocol EUAs, clinical evaluation by Stanford CLIA lab with 98% (PCR) and 90% (LAMP) sensitivity, and 100% specificity, pre-EUA sub for pooled home collection w/ FloodLAMP Mobile App, IRB approved.
- Key advisors, collaborators and industry connections (Anne Wyllie of SalivaDirect, Robby Sikka's Sports & Society call, gLAMP consortium, NEB, LGC)


## Lower Left Quadrant
### Benefits:
- Scalable and replicable high quality molecular screening, deployable anywhere;
- Rapid response to hot spots: 10K/day capacity bringup in 24hrs;
- Outbreak risk reduction and disease suppression in high-need communities;
- Acceleration of return-to-normal and economic activity;
- Increased adoption over DIY antigen tests through convenience to end user;
- Improved mitigation effectiveness of pooling at the family/household level;
- Establishment of critical new regulatory paradigm – the generics of diagnostics through open source protocol FDA authorized tests, LAMP primer standards, and point-of-need flexible public health testing.

### Challenges:
- Regulatory barriers – access to FDA review as a startup;
- Supply chain and staffing;
- Educating the public and political leaders of the benefits of frequent screening.

### Maturity of Technology:
- Demonstrated real world success of full programs at multiple sites;
- Test system clinical evaluation successful and FDA EUA validations completed;
- Patent filings and licenses in place to secure control of key IP; 
- Pilot manufacturing of test reagents (40K reactions/day);
- Reagent supply partners in place (LGC Biosearch and New England Biolabs);
- Quality system and training program in development.


## Upper Right Quadrant
### FloodLAMP Mobile App:
- At home collection of family pools;
- Lightweight LIMS for tracking and reporting;
- Admin for mgmt, results, and metrics.
_Screenshot of the FloodLAMP Mobile App interface used for at-home family pool collection, tracking, and reporting._

### QuickColor(TM) COVID-19 Test and Turnkey Screening Program:
- Instrument free rapid molecular test,
- 2 hrs to setup and validate site,
- 10K+/day throughput at <$5K cost.
_Photo of a QuickColor™ testing setup showing reaction tubes/plate and simple lab supplies for an instrument-free rapid molecular screening workflow._


## Lower Right Quadrant
### Major Milestones:
#### Milestone 1 - State level contract for all EMS sites screening first responders:
- Hub and spoke model for smaller departments;
- Pilot expansion to under served communities, schools and workplaces.

#### Milestone 2 - FDA open source protocol EUAs for pooled direct LAMP and PCR:
- Complete asymptomatic clinical trial with enrichment strategy;
- EUA for DTC pooled collection kit using FloodLAMP Mobile App;
- Quality and training systems completed;
- U.S. FDA EUA enables global distribution and copy cats.

#### Milestone 3 - Full suite of open source resources:
- Modern website with all information, tools, products for various scales;
- Includes quality and training systems.

#### Milestone 4 - 5M tests deployed:
- Key reagents are in-hand, ready to kit and distribute.

### Proposed Funding:
- Phase 0: 1 week – deep dive due diligence;
- Phase 1: 2-4 weeks – workplan incl Milestone 1 and TBD based on feedback;
- Phase 2: 2-6 weeks – workplan incl Milestones 1, 2, 3  and TBD based on feedback.