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file_name: 2020-12-09_FloodLAMP FDA Townhall Engagement on Open Source FDA IVD EUAs and Generic Molecular Tests.md
file_date: 2020-12-09
title: FloodLAMP FDA Townhall Engagement on Open Source FDA IVD EUAs and Generic Molecular Tests
category: regulatory
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notes: 
summary_short: The “Dialogue on Open Source Testing and FDA IVD Authorization of Generic Molecular Tests” summarizes a December 9, 2020 FDA town hall exchange about using Rights of Reference and “method” EUAs (modeled on SalivaDirect) to enable interoperable, non-proprietary molecular test protocols across laboratories. It outlines how open IVD EUAs could reduce duplicative validation, strengthen supply-chain resilience, and scale testing via a structured lab designation process, positioning FloodLAMP’s strategy to expand this open-access paradigm beyond SalivaDirect.


CONTENT

***INTERNAL TITLE:*** Dialogue on Open Source Testing and FDA IVD Authorization of Generic Molecular Tests

12-9-2020 FDA Town Hall


## Can listen to the 7 minutes of audio [here](https://www.youtube.com/watch?v=-7K-zmy-ouU&t=300s)


## High Level Summary:
FDA authorizations for tests can be made completely open (so any lab can order the ingredients directly from suppliers) and interoperable (through Rights of Reference to the validation data). The potential of this open source/open access paradigm of testing is immense but almost totally unknown to government leadership. It has received no funding out of the billions that has been spent expanding the highly profitable, proprietary status quo of the diagnostics and clinical testing industry. Yet the FDA itself is fully aware of the potential for this open approach and embraced it with the [first "open source protocol" EUA SalivaDirect](https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-emergency-use-authorization-yale-school-public-health). Part of FloodLAMP's mission is to quickly expand this paradigm to several more key open source EUAs, and in doing so unlock and massively expand testing in the United States.


## Transcript:
[**Randy True**](http://www.linkedin.com/in/randy-true-fof), Founder of [FloodLAMP Biotechnologies,](http://www.floodlamp.bio) a Public Benefit Corporation

randy@floodlamp.bio

[**Dr. Timothy Stenzel**](https://www.linkedin.com/in/timothy-stenzel-md-phd-20204521/), FDA Director, Office of In Vitro Diagnostics and Radiological Health

[05:00 Randy True](https://www.youtube.com/watch?v=-7K-zmy-ouU&t=300s): *FloodLAMP is coordinating with other open source test developers. If we establish a consolidated primer set and give a general right of reference, then we won't individually have to repeat certain aspects of the validation, correct? Want to understand that dynamic a bit more in terms of the inclusivity, in silico analysis, and the in silico cross-reactivity and the wet cross-reactivity. Can you give us guidance as we coordinate on this?*

[00:06:34 Dr. Timothy Stenzel, FDA](https://www.youtube.com/watch?v=-7K-zmy-ouU&t=394s): *Yeah, we've seen that is a pathway that could be very successful. Yale's SalivaDirect was the first.*

*As far as the data related to test performance, yes that can be leveraged in multiple ways. The two main ways are that if you seek your own authorization for the path, you can give a right of reference for anyone else who wants to copy you. That wouldn't eliminate the requirement for them--if they're a kit developer, say--for them to come in to get their own authorization. And it wouldn't extend the umbrella of an EUA authorization to any lab that might copy that method.*

*So, looking at the Saliva Direct model, they have in their original submission, they have an IFU that's the sole basis (so to speak) of their kit. And they point to off-the-shelf product that users can purchase. In the case of primers and probes for their test (I think it's the CDC's), they can get that from vendors that produce primary probes under the CDC authorization. So those are very specific catalog numbers, and those are primers and problems that we previously authorized.*

*So again, there's these two different pathways. I want to lay them out very clearly:*

*1) You can get your own, individual authorization for a kit. You can then give anybody (any other developer) the right of reference to that, and they can copy it, and they can pretty much link up and use the data in your submission. There are some elements that if they were to be changed, that we'd want to see. But if they're using the same suppliers and the same catalog numbers for everything that you're using, then that makes it very easy.*

*2) The other way is to have this method authorized, as we did for SalivaDirect. Then we would envision giving you (or any other sponsor) the same sort of flexibility. Yale is actually the one that designates which lab can use their method and are therefore covered by their EUA. And they have commitments to the FDA on what is required and making that determination of designation. And my understanding is they've designated quite a few labs already, and I would refer you to them if anybody wants to know those numbers, but it appears to be a very highly successful program.*

[10:18 Randy True](https://www.youtube.com/watch?v=-7K-zmy-ouU&t=618s): *Yeah, they've been our inspiration for this modality and effort. I guess just one quick follow-up question: So if we get authorization for a test with a certain lysis or inactivation buffer and a certain purification... Like, we're pursuing an ultra-cheap glass milk purification, but we're working with another test developer who is seeking authorization for a magbead based purification that would be highly amenable to automation. If we consolidated on the same primer set and LAMP master mix, then it's my understanding they wouldn't need to repeat the upfront parts. But with respect to the interfering substances, would they need to repeat that? And then if we gave them a general right of reference, then they would end up getting their own EUA that they could control the designations on, and then we would have our own, independent EUA that we controlled the designations on, even though we granted a right of reference. Is that how it would work?*

[11:30 Tim Stenzel, FDA](https://www.youtube.com/watch?v=-7K-zmy-ouU&t=690s): *At a high level you're close. The devil is sometimes in the details. There are certain alterations to a test that may require additional validation. So if they're adding something new that you didn't do, say, then we would want to evaluate the data around that change. And then absolutely developers can give each other right of references as they so wish. They can specify what right they have from their entire EUA--they can have limitations, or they can open it up entirely. But you can basically cross-reference each other's assays to the extent that you want. And there would absolutely be synergy. And if the components are all the same that you use for the core test, then there would absolutely be synergy on reducing any sort of duplication. I look forward to hearing more about your development.*

## Commentary

SalivaDirect is still the only open source IVD EUA. The potential of this new paradigm of testing that's open access, low cost, and supply chain robust, still has not been tapped. Essentially it's "generic" molecular testing. The vast majority of tests are slight variations on a few core protocols. But those are silo'd for commercial reasons. Even with the FDA submission or validation of tests developed at universities, these tests, because they are LDTs not IVDs, are not transferable to another lab and usually face supply chain shortages.

*What's the solution*?
- Several key open source IVD EUAs
- The standardized supply chain to support these tests
- The team and funding to support the lab designation process to rapidly scale

We are coordinating on the standard primers for LAMP and will give a blanket Right of Reference with the first open LAMP EUA, just as the CDC did for PCR. FloodLAMP is in discussions with manufacturers to secure a production scale supply that can be offered at scale with fast turnaround and low cost. The LAMP primer ROR can then be used by both IVD and EUA submissions, and would be available for non-CLIA surveillance testing.

The cross referencing capability Tim Stenzel describes is not well known outside of the industry, as molecular Dx companies (aka IVD Kit Manufacturers) don't openly give these Rights of Reference. They keep the ingredients of their tests trade secret, even when they are the exact same formulation as off-the-shelf RUO products.

The "designation" of labs for an open source IVD EUA is a new process. SalivaDirect has been a big success but they've only been able to designate about 50 of 400+ labs that have requested to use the EUA, over 4 months. That's because of the Yale team's limited resources and the bureaucratic nature of academic institutions. FloodLAMP will build an organization to rapidly designate hundreds of labs.

The simple fact that EUAs can be made fully open is very powerful. This seems to be entirely absent from proposals to quickly scale up testing in the U.S. Wyllie and Grubaugh have created the model with SalivaDirect. It will be far better to not get the next open IVD EUAs through universities because of their institutional bureaucratic nature and their top prioritization of publications, branding and credit. FloodLAMP, a public benefit corporation, is seeking several open EUAs, having filed a pre-EUA on one LAMP test so far.. FloodLAMP is executing on several fronts: technical and scientific, regulatory, the commercial supply chain, and legal aspects. We've built the knowledge and relationships to make generic molecular testing a reality, in Q1 of 2021. FloodLAMP is seeking capital from sources that support our public good mission. Instead of yet another proprietary test that will barely make a dent in the nation's testing capacity, our "product" is a new paradigm of low cost, widely accessible generic molecular testing. This will have great positive impact on the COVID crisis, and has longer term benefits in healthcare more generally.