Week in Review: Flurry of FDA actions | Google Health's pathology AI demo | Tool for typing serous ovarian cancer

Dear LabPulse Member,

One of the heartbreaking casualties of the COVID-19 pandemic, in my opinion, is the loss of live music. I have a personal stake in this as a jazz vocalist who has had to absorb performance cancellations on top of all the other privations.

What's worse, singing appears to be an especially risky business. So, when a musician colleague asked me to get together -- provided I test negative for COVID-19 -- I was curious even though I know the value of a diagnostic test is fleeting. And besides, a small, distanced, outdoor Father's Day gathering is coming up, so I took the plunge and went for a drive-through molecular test in San Francisco this week.

Apprehensive as my car pulled up to a parking lot tent, I asked the shielded healthcare provider if the swab was one of those ultralong sorts. Oh no, he assured me, those are no longer being used. People are afraid of them and it's keeping them away from testing, he said, asking me to spread the word.

The next day, I got my negative result online. Testing was painless, free, and fast. It doesn't get any better than this, I thought.

Testing of asymptomatic people has been discouraged since the beginning of the pandemic, but there are signs that policies are becoming more flexible with the opening of state economies and wider availability of diagnostics. In addition to drive-through pop-up sites, at-home saliva specimen collection kits are now available and 3D swab products have been developed in response to shortages of supplies.

This week, the U.S. Food and Drug Administration (FDA) published templates for diagnostics developers that want to market their assays for use in broad screening of asymptomatic people and for batch testing.

In other FDA news, the agency announced additional actions that follow through on its commitment to crack down on shoddy test products. Emergency use authorization for Chembio's immunoglobulin G (IgG) and immunoglobulin M (IgM) test was revoked after the product failed to meet performance criteria in an independent evaluation conducted by the U.S. National Cancer Institute. The Chembio product had been one of the first antibody tests cleared through the agency's emergency pathway.

The FDA also issued warning letters to test manufacturers for violations that included offering tests directly for at-home use without marketing clearance and misbranding of tests. In announcing the warnings, the FDA offered a reminder that no products are cleared for completely at-home use.

Taken together, the agency's recent actions suggest it is serious about tackling problems with the quality of COVID-19 diagnostics going forward.

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