Worthwhileness for a small startups to apply for EUA (Emergency Use Authorization) for COVID-19

[Watchcat]

FDA is asking for the normal amount of information plus manufacturing information

That is encouraging to hear. I gave up following this saga, but initially it was asking for nothing, as far as I could tell. Then it upped its game, but have not been sure by how much. Also, lack of transparency, no way of knowing whether it is asking for the same amount of information from all applicants. And of course, no way of knowing how much it is reviewing all that information.

If it is really asking for the same information, and really reviewing it, then no reason for an EUA. At least no good one, that I can think of. I think there is a real possibility that FDA does not have confidence in its ability to review these products.

 

[Carol2015]

I am currently the Quality Director at a Dx startup that received EUA for a Covid test. It helps in that we received federal money to develop the assays, one for antibody and another for antigen. We're far from being the only ones, as the NHI has given out money to lots of companies similar to mine, as there is need for testing. So, to me, that's worth it because without it, who knows if we would still be in business.

 

[shimonv]

That makes sense. Thank you Carol.

 

[Watchcat]

we received federal money to develop the assays, one for antibody and another for antigen....NHI has given out money to lots of companies similar to mine, as there is need for testing. So, to me, that's worth it because without it, who knows if we would still be in business.

Thanks for sharing your experience. Yes, if that's the only way the startup can survive, it would be worth it to everyone employed by the startup. In most cases, even "old normal," medical device startups don't survive, so more a matter of how long it takes until they fail. But this is not good time to have your employer fold and be looking for the next thing.

I think this was probably early in the pandemic? I'm not sure if funding is still as readily available now, especially for antibody tests, given the large number that have already received emergency authorizations.

I'm not that familiar with the market for COVID-19 tests. To what kinds of buyers do you market your tests?

 

[Carol2015]

Thanks for sharing your experience. Yes, if that's the only way the startup can survive, it would be worth it to everyone employed by the startup. In most cases, even "old normal," medical device startups don't survive, so more a matter of how long it takes until they fail. But this is not good time to have your employer fold and be looking for the next thing.

I think this was probably early in the pandemic? I'm not sure if funding is still as readily available now, especially for antibody tests, given the large number that have already received emergency authorizations.

I'm not that familiar with the market for COVID-19 tests. To what kinds of buyers do you market your tests?

Yes, our CEO came up with the idea in March - shortly after the shelter in place ordinance. We, and many other companies, applied at the time for funds to develop the tests. We actually applied to two NHI programs, but only got approval for one. The other one, which came with a lot more $$$, wanted tests for antigens (which we're still developing) and also proof that we had the capability of building thousands of units in one month.

As far as markets, we're working with UCSF and UCSD for now and, of course, the government has need for the tests for its military and federal and state use.

 

[Watchcat]

Yes, our CEO came up with the idea in March

That was my first guess. I think that it's a little late to pursue most COVID-19 products now.

As far as markets, we're working with UCSF and UCSD for now

Does that mean you are in CA? I like the idea of startups meeting local demand, given the apparent lack of a coordinated national response.

 

[indubioush]

tests for antigens (which we're still developing)

Carol, was your company able to finish development of the antigen test? This is the hot topic these days, as a quick and cheap antigen test could allow schools to reopen, etc. There are not too many antigen tests out there that have received EUA. Did you get it?

 

[Mark Meer]

...After all, it's only a temporary approval and when the EUA is terminated, all unapproved devices will need to be recalled...

I wasn't aware of the recall requirement. So basically: (1) you must demonstrate production capacity to supply to all of domestic US; (2) you will eventually have to perform a recall of all the EUA devices you distributed throughout the US.
...pretty tough on the resources of a small start-up....