Thread by @michaelmina_lab

Here’s a frustrating secret

Today - in midst of Omicron - millions of Americans are begging for access to rapid tests, thousands dying daily.

Get this:

many manufacturers with very high quality rapid tests are begging To ship 100’s of millions of tests to US

But can’t.

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These are some of the largest companies in the world that make diagnostic tests.

Their rapid tests have been used the world around in this pandemic with research paper after research paper showing their benefit and quality.

But FDA has them in a holding pattern for months

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Why?

Bc despite tremendous amount of data from real world use in millions of ppl - FDA demands the companies check off onerous but remarkably useless check boxes designed for evaluating medical devices.

FDA formally does not recognize that public health testing exists

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Instead of simply recognizing data accrued over millions of people and evaluating use as EMERGENCY public health tools based on that,

FDA demands each company run literally uninformative trials to compare 30 tests between the rapid test and lab PCR

Sounds easy? Wrong.

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They stubbornly continue to ask for rapid tests to be compared to PCR. The two tests are not comparable.

So finding just 30 positives and showing an 80% concordance with PCR is exceedingly difficult Bc PCR stays long for SO long!

So you have to cherry pick each participant

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FDA effectively REQUIRES test manufacturers skew their clinical trial participants to an extreme extent so they’re sure to recruit only ppl w high virus load

The FDA evaluation literally measures how savvy you are at recruiting the right ppl, not the test performance

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FDA has delayed and delayed nearly every test (except two: Quidel and Abbott) in order to effectively ask the question:

“do you have enough money to work w a savvy trials company to figure out our game of recruiting people in short specific periods of their infection”

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In the past couple of months, more rapid tests have gained authorization despite such an exceedingly difficult process - but we don’t have enough.

We could immediately enable the tests that are currently in the queue that have been recognized as the top performers by WHO

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Here is a HIGHLY disturbing article about what has gone wrong and the MASSIVE conflict of interest by one of the two ppl who led the EUA process for most of this pandemic:

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propublica.org/article/heres-…

To finish this tweet - there 3 exceptionally simple changes that FDA could make to GREATLY speed up the authorization process to days not months/years

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First:

Recognize the ample data around the world. Trust our peer nations and offer immediate EUAs to the best companies that are producing and scaling the best across the world.

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TWO:

Allow rapid antigen tests to be compared to a gold standard rapid antigen test (BinaxNOW).

Require high bar: >95% positive agreement with BinaxNOW (or >100% even)

Require False Pos rate of <1:2000

This would allow trials to be complete in a few days!

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THREE:

Allow EUA test trials to recruit ppl who are already identified as positive

It would GREATLY speed up recruitment if didn’t have to guess who might be a useful participant - and could directly recruit people with virus in their nose.

Pretty obvious

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FOUR (adding 1 more)

The should have an outside expert advisory group for tests

Just like vaccines have #ACIP who advise and tell the FDA what qualities of the vaccines to look for (and similar w anti-virals) WHY is there not an outside expert committee to advise on tests.

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