Thread by @ASlavitt

COVID Update May 5: It’s time to put on our big boy pants and turn testing into a real industry so that every American who wants a COVID test can get one.

But instead of taking that on, the White House task force is abandoning ship. 1/

This is a time for American leadership to move from hundreds of thousands of tests/day— which traps us in a stagnant economy w high death tolls. And millions/day which would allow us to get back closer to normal, including having public events.2/

Testing in America was built as a bespoke industry— like the tailor that makes & measures suits.

After all, you get their cholesterol tested once/year, you don’t need it the same day & you value precision & safety. 3/

Testing needs to be turned into a scale industry that can safely process millions tests/day. This will mean open sourcing, barcoding, logistics, R&D investment and ubiquitous points of service. It also means challenging incumbents & breaking up control. 4/

Congress just allocated $25 billion to testing. That money can get all of this done IF spent with an industrialization plan.

And IF the money comes w strings. Anyone who takes $1 of taxpayer money for COVID testing must be required to open source their technology & components.5/

This can be done. The system designed by the FDA & CMS (which oversees clinical lab certification) was built for safety & accuracy. But many barriers aren’t needed, because we never needed speed & didn’t face a crisis. 6/

I used to oversee CMS, which did the lab certification, over the last several weeks have talked to labs & pharmacies, states & the fed government & many working on this problem.

This thing needs to be turned on it’s head. Here’s how... 7/

1. Getting tested:
Today you need a Rx & a nurse present. Waive those requirements. Labs will instantly double capacity.

Drive-through & home testing should be dominant. But also airports, offices, restaurants, grocery store, nursing homes, prisons & public housing. 8/

2. Collecting samples:
Until recently we used bespoke swabs from Italy & Maine. Unnecessary.

FDA approves ordinary sanitized q-tips like swabs. They can be open sourced & sanitized. Use the DPA to produce 1 billion swabs in factories across the US. Saliva tests too. 9/

3. Speed & logistics:
Tests are currently sent by mail, processed and then sent back. Almost entirely by paper ordering.

Barcode every test so we can bring drop off points. Have lab download results to your phone as soon as it’s processed. 24 hr turnaround or fee cut in 1/2. 10/

4. Accuracy:
The FDA has granted emergency use to many tests.

Their accuracy rates must be posted publicly. 24 hour tests should be 90%+ accurate. Results should carry a QR code & date stamp so you can use for entry.

There are also more limited 5 minute tests. 11/

5 minute tests can be less accurate. If given to asymptomatic people, accuracy in the mid-70%s is ok. They can be administered 2-3 times depending on use— entry to work or if using a mask vs. for a nursing home or if symptomatic. 12/

5/ Technology/R&D. The highest speed liquid handling robots are in short supply & require consumable tips. They can turnaround between 50-120 tests/hr, 20 hrs per test. Only 110 are in the US. This must be ramped up. 13/

Taxpayer funds must be used for new tech & to create new tests. We need machines with fewer consumables & no specialized instruments. All should be open source. Tests which can use heat or other simple processes. Collaboratives are already working on this & must be funded. 14/

6/ Today labs have lengthy regulatory hurdles to be able to do COVID tests. For good reason— these are infectious samples.

We can expand the number of labs to add 1 million new tests/day by converting academic labs. Require only a CLIA certified lab director to get a waiver.15/

7/ Supplies & reagents are needed to process tests. They are in short supply because they fit in special cartridges.

Recipes for reagents should be open source so any lab can make them. And cartridges should be mass produced by any manufacturer using DPA. 16/

8/ Allocation of resources. Load imbalances are everywhere. Some labs have some ingredients but lack others & vice versa.

A national supply chain clearinghouse with all supplies & shortages can allocate supplies. Accuracy, scale & speed should determine who gets priority. 17/

Our country is increasingly dependent on massively increasing testing. Unless we dramatically increase availability, our economy will remain stalled & our horrible death count will continue. 18/

This is achievable but it won’t happen on its own. It requires federal leadership & a willingness to bang heads. $25 billion shouldn’t just float into the ether. 19/

Testing is just one of the things a high functioning national task force with clear leadership can make happen.

Leaders are jumping ship when there is much to do. /end