Thread by @davidboxenhorn

This is the podcast on Covid self-tests that you have to hear. It answers all your questions. Takeaway: It's the bureaucracy, stupid! Only 21 minutes, and Gladwell is an excellent interviewer. My notes are below

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https://twitter.com/Gladwell/status/1306311547342458882

Gladwell: Why are we not doing this?

Mina: It's been first and foremost a regulatory hurdle

The only paths we have to evaluate tests like this in the US are medical diagnostic pathways. They're pathways designed specifically to ensure that a physician, like a detective, is getting all of the information they need to diagnose a sick person in front of them

So it's been first and foremost a regulatory hurdle. We don't have a regulatory pathway to approve a test whose primary objective is one of stopping an epidemic.

That's held everything up.

All the companies that could be producing these tests in the millions, they have been sitting on these tests trying to hone them, trying to get them just a little bit better so they can pass through FDA standards

It's not just slowing down their approval, it's actually bottlenecking the companies into creating tests that are not as scalable... they have to become more expensive, highly-manufactured tests

If we can do the cheap version of them, they can be made very fast, but they won't get though the FDA

How dumb are the FDA?

It's not that they're not smart, it's that they're a regulatory body. They just don't have a pathway. You can't apply for a public health tool. That might make you say "why bother getting FDA approval?"

Unfortunately, these tests are defined as clinical diagnostic tests.

Definition of diagnostic test: tests that give information that changes people's behavior. The FDA doesn't want to change the rules, and doesn't want to say the rules don't apply

There is precedent at the FDA to consider public health: A vaccine will be approved even if it's only 50% effective.

This could make people think they are immune when they are not, but they are approved because it leads to herd immunity

If the FDA stops regulating, how long before we can buy these tests over-the-counter?

We have them now! Abbot has a test, but it's approved only for medical diagnostic use

The blueprints for these tests are publicly available. No IP. You can get royalty-free, non-exclusive rights to just produce these tests.

People are dying because regulation is preventing us from making a test for pennies, sold for a dollar, that can stop the pandemic

Where can I buy these tests legally?

South Korea is one country. Canada is starting to produce them. India, Singapore. South Korea makes the highest volume

For more information, go to this site:

rapidtests.org