Thread by @michaelmina_lab, THREAD: First at-home rapid test w FDA EUA! This is a [...]

THREAD:

First at-home rapid test w FDA EUA! This is a great milestone! Congratulations to @EllumeHealth on this triumph. The EUA for this at-home test should be celebrated. I am supportive & have used it myself! I want to put this in context...

https://www.npr.org/sections/coronavirus-live-updates/2020/11/17/936055284/fda-approves-first-at-home-coronavirus-test

1/10

FDA Approves 1st At-Home Coronavirus Test

The Lucira COVID-19 All-In-One Test Kit is expected to provide results in 30 minutes or less. Its approval could help alleviate the strain on the nation's precarious coronavirus testing system.

https://www.npr.org/sections/coronavirus-live-updates/2020/11/17/936055284/fda-approves-first-at-home-coronavirus-test

This is a terrific milestone. An OTC rapid test is a great advance. It means some will have access to much needed test to help know status, without going through barriers of an MD.

Since many are asking, this is not quite THE public health screening test I'm calling for.

2/10

Inside, @Ellume (right) has simple but powerful paper strip test. It requires battery, circuits, sensors, and bluetooth with a mobile phone. Thus, not quite THE mass public health screening test that will scale for frequent use by millions (i.e. vs simple one on left).

3/10

Rather, this is great tool to buy once/twice for ~$30?? (Not sure of price).

That Ellume got an OTC claim for this is great!! I do not want or intend to diminish this needed achievement at all.

However - I think (for FDA OTC) it means most dominoes should now fall....

4/10

There is now no good reason I can see to tests be fully by prescription only, since MD prescription is more about whether someone can understand what it means to be positive or negative. Once one is enabled, all should be considered for OTC (non-prescription).

5/10

By making a test OTC (or 2-Pixel lab-based PCR is OTC)-it begs question of whether any tests should remain prescription only. I do not think so. However, if they are not, we must have public health distribution - else I fear will all be bought up by rich and powerful.

6/10

By keeping these purely in the free market is a potential disaster given overall lack of public health agency to have a coordinated response.

I do not want to see the wealthy have access but the poor have none.

That is one of the saddest endpoints of all of this.

7/10

So... I am delighted to see the FDA giving OTC claims for rapid tests & this @EllumeHealth test will absolutely be a great addition!

8/10

IMO this test, because it's a bit more $$ and more limited supply, should, ironically, probably be considered along lines of a medical device versus tests like the BinaxNOW - simple paper strips - which are the more frequent accessible public health devices we need.

9/10

To conclude, I am in full support of tests making way out to OTC & think this will be a great addition!

I do hope it doesn't drive more of a wedge between haves and have-nots and hope it is the start of a major increase in fast, frequent, accessible tests.

10/10

I posted the wrong @NPR article at the top of this thread.

Here is what I meant to post Re @EllumeHealth gaining EUA. https://www.npr.org/sections/health-shots/2020/12/15/946692950/fda-authorizes-first-home-coronavirus-test-that-doesnt-require-a-prescription

FDA Authorizes First Home Coronavirus Test That Doesn't Require A Prescription

The new tests produce results completely at home within 15 minutes. Experts say they could be a 'game-changer' in helping people find out quickly if they need to isolate.

https://www.npr.org/sections/health-shots/2020/12/15/946692950/fda-authorizes-first-home-coronavirus-test-that-doesnt-require-a-prescription

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