Thread by @cha_myoung

1/ One of the biggest policy failures over the last 2 years is the lack of COVID testing, particularly evident now with omicron — both the supply and the quality of what we have available at scale. Where is our Operation Warp Speed for diagnostics? 🧵

2/ Based on the sheer scale of testing volume, it’s clear many are concerned with exposure to omicron and are not yet “done with COVID”. Labs are reporting >1.5 million PCR tests per day right now. But this is a massive underestimate of the total volume w/antigen tests in the mix

3/ Based on recent disclosures, the leading antigen test kit mfg. production volumes right now are estimated to be ~120 M tests/month

@AbbottNews: 50 M/month
@QuidelDX: 70 M/month

This is ~4x the reported daily PCR volume with a clear hunger for even more from consumers.

4/ While Biden announced a shipment of 500M more antigen tests in the next month, I am concerned that the predominant use case for these tests doesn’t fit this kind of test. See this @statnews article.

statnews.com/2022/01/05/stu…

5/ This small study shows that if you are trying to host a gathering, antigen tests can be a porous sieve of asymptomatic infections (false negatives) that can transmit at a high enough rate to infect others.

6/ With the wide-ranging cheap supply of antigen tests in Europe, I wonder if this kind of testing has provided a false confidence that has unintentionally led to even greater transmission of omicron than otherwise would have happened. Hard to tell.

7/ This is why I think there will still be a key role for molecular testing, which is largely limited to large reference labs and POC PCR machines. But why not a molecular test with the convenience of antigen tests at a compelling price point that could be done at home?

8/ Some history: with great fanfare, the NIH Rapid Acceleration of Diagnostics Initiative (RADx) launched in April 2020 with the goal of deploying millions of tests per week by fall 2020 through a "Shark Tank" fast-track competition to distribute $1.5 Bn of funding.

9/ The first winners of the competition won contracts worth ~$250 M in July 2020

POC systems: Mesa, Quidel, Talis
Lab-based systems: Ginkgo, Helix, Fluidigm, Mammoth

10/ Where are we now with these initial ”winners”?

Mesa: acquired by Thermo
Quidel: 70M antigen tests/month (spoken for above)
Talis: EUA in Nov ’21
Gingko: pooled testing for schools
Helix: 100k tests/day
Fluidigm: $1-2 M revenues in Q4 ‘21
Mammoth: vapor

No game-changers IMO

11/ There are other MDx companies that have received government support to accelerate and scale up. Cue Diagnostics is probably one of the more prominent examples with a pretty unbelievable $481 M from HHS and DoD to scale up.

mobihealthnews.com/news/cue-healt…

12/ A promise from Cue of 100,000 tests/day by March ’21 has become 60,000 tests/day by Nov ’21, which is a drop in the bucket compared to the deluge of demand for home testing (4M/day). Much of this capacity goes to high-end customers like Google employees.

https://twitter.com/itsmissfox/status/1472606901707943938

13/ There is a gap in the market for a low-cost, high-sensitivity, rapid test that can be produced at mass volumes (upper-right of the chart below).

14/ I have some hopes for @DetectTest, which RADx funded last October.

theverge.com/2021/12/22/228…

15/ For many of these smaller home Dx companies, there was always a “next chapter” problem of “what will you do when COVID is over?”, which I imagine is less of a barrier these days to raising capital.

https://twitter.com/cha_myoung/status/1475272243043201025

16/ A molecular platform in the home that achieves scale will become one of the larger companies in healthcare, but that scale needs to be in the millions, not thousands, for it to have the impact we need right now.