Share Dialog
Since I wrote my post on “The Road Back from COVID19″ we have made lots of progress on two out of the three pillars: masks and tracing. Masks went from a discussion of their merits to being mandatory to wear in public in several states, including New York. Tracing went from a hodgepodge of approaches to an API supported by both Google and Apple. On the third pillar of testing, however, we are massively behind.
It is by now well understood that the virus is transmissable for several days before the appearance of symptoms. To be able to reopen without immediately heading back into a steep infection curve that would once again overwhelm ICU capacity, we must ramp up testing dramatically with a target of many millions of *daily* tests. Ideally people could test themselves at home and/or at work several times a week with results in minutes.
Is that just crazy or can we get there? Yes because the required technology already exists, we just need to approve it and manufacture it at scale. Here are just two examples of machines, the MicrosensDx and the Accula. There are many more startups and established companies that have tests and there are fascinating proposals for
Share Dialog
Since I wrote my post on “The Road Back from COVID19″ we have made lots of progress on two out of the three pillars: masks and tracing. Masks went from a discussion of their merits to being mandatory to wear in public in several states, including New York. Tracing went from a hodgepodge of approaches to an API supported by both Google and Apple. On the third pillar of testing, however, we are massively behind.
It is by now well understood that the virus is transmissable for several days before the appearance of symptoms. To be able to reopen without immediately heading back into a steep infection curve that would once again overwhelm ICU capacity, we must ramp up testing dramatically with a target of many millions of *daily* tests. Ideally people could test themselves at home and/or at work several times a week with results in minutes.
Is that just crazy or can we get there? Yes because the required technology already exists, we just need to approve it and manufacture it at scale. Here are just two examples of machines, the MicrosensDx and the Accula. There are many more startups and established companies that have tests and there are fascinating proposals for
We need to take three steps right now: (1) approve lots of these test immediately and (2) manufacture at scale and (3) monitor ongoing results. Here is how to accomplish this
Step 1: Approval
The regular FDA approval process needs to be completely sidestepped. Instead we either go a decentralized route, allowing states to approve their own tests, or we put together an approval task force recruited from the leading test scientists. The goals for that group should be to greenlight dozens of tests within the span of days and to then define follow-up reporting requirements to enable ongoing monitoring (step 3 below).
Step 2; Manufacture
There are lots of components to these tests and they are not easy to manufacture. But there is definitely manufacturing capacity that could be repurposed. To do so quickly I believe we will have to invoke the Defense Production Act as well as be willing to spend a lot of money. Every dollar spend on testing will unlock a multiple in economic activity so this is among the best money we can spend, even if some of the tests we buy don’t work well (or maybe not even at all). Having more different tests approved in Step 1 means we can lean into manufacturing much harder with a portfolio approach.
Step 3: Monitor
Finally we need to set up a reporting and stats infrastructure to monitor the performance of the tests as they are deployed so that we can hone in on the ones with the best sensitivity and specificity. With the right reporting protocols we will rapidly learn what works well.
Essentially this amounts to reversing the normal approval process which takes a long time with the goal of having only high quality tests in market. Here we want to optimize for speed and massively over allow, then pull back later. Because this is so essentially a 180 from the FDA’s normal operations we need a special one-time panel on this.
Governors should be exerting public pressure right now calling for this and if it has not been put in place by end of next week they should proceed on their own.
We need to take three steps right now: (1) approve lots of these test immediately and (2) manufacture at scale and (3) monitor ongoing results. Here is how to accomplish this
Step 1: Approval
The regular FDA approval process needs to be completely sidestepped. Instead we either go a decentralized route, allowing states to approve their own tests, or we put together an approval task force recruited from the leading test scientists. The goals for that group should be to greenlight dozens of tests within the span of days and to then define follow-up reporting requirements to enable ongoing monitoring (step 3 below).
Step 2; Manufacture
There are lots of components to these tests and they are not easy to manufacture. But there is definitely manufacturing capacity that could be repurposed. To do so quickly I believe we will have to invoke the Defense Production Act as well as be willing to spend a lot of money. Every dollar spend on testing will unlock a multiple in economic activity so this is among the best money we can spend, even if some of the tests we buy don’t work well (or maybe not even at all). Having more different tests approved in Step 1 means we can lean into manufacturing much harder with a portfolio approach.
Step 3: Monitor
Finally we need to set up a reporting and stats infrastructure to monitor the performance of the tests as they are deployed so that we can hone in on the ones with the best sensitivity and specificity. With the right reporting protocols we will rapidly learn what works well.
Essentially this amounts to reversing the normal approval process which takes a long time with the goal of having only high quality tests in market. Here we want to optimize for speed and massively over allow, then pull back later. Because this is so essentially a 180 from the FDA’s normal operations we need a special one-time panel on this.
Governors should be exerting public pressure right now calling for this and if it has not been put in place by end of next week they should proceed on their own.
>300 subscribers
>300 subscribers
No comments yet