Thread by @michaelmina_lab

This is tremendously good news! (Thread)

@POTUS fully supporting scale up of rapid at-home tests

I've been arguing for this - the Defense Productions Act to be invoked since early last year to drive production of rapid tests

Testing in a pandemic is a Public Health need

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https://twitter.com/POTUS/status/1436088275630952455

While I am tremendously happy to hear the President say this.

I do have my reservations:

Time is of the essence. If we start the scaling process now, it will take a long time.

Meanwhile many many tests exist globally. We could be using those for the time being.

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Importantly, I worry that the 280 million tests that are going to be purchased and produced with the use of the DPA... well, that's less than one test per person over the course of a year. The number sounds big but we do have 330 million ppl in US.

But it is a great start!

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The fact that this is on the president's radar as a major tool in this fight, and the interest to help get them out to people is a big step forward. My hope is that this still will allow the administration to see the benefits, for this pandemic and for future prepardness

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I do worry that the WH has not recognized perhaps THE fundamental problem that has limited widescale rapid testing in US. It's not the need for the DPA, but it's how we define these rapid tests that is causing us to fall so greatly behind many of our peer nations

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As long as these tests are regulated as medical devices, the FDA has to regulate them not as critical public health tools, but as medical tools, with all of the onerous clinical trials that slow everything down 100-fold.

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I was really hoping to hear @POTUS remark that from here on out, testing for COVID is a PUBLIC HEALTH tool and the regulatory requirements for PUBLIC HEALTH tools should be distinct from MEDICAL TOOLS.

THE CDC / NIH could evaluate and oversee

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https://twitter.com/michaelmina_lab/status/1435367919865712644?s=20

As long as rapid tests are regulated as Medical Devices, FDA is compelled to compare them to Medical Devices (lab based PCR) for EUA

As I've discussed SO many times, this comparison doesn't make sense bc use of rapid tests in a pandemic is not medicine, it's public health

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For public health, the goal of rapid testing is detecting HIGH levels of virus to stop spread and to do so at low cost and in a highly accessible manner

For medicine, you want to detect even very LOW levels of virus to diagnose patients - not to protect patient's neighbors

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So, I do hope we can see our way to understanding that public health testing is not medicine and the regulatory environment, including the "gold-standard", should change for evaluation of a public health test.

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