private beta
search about

Resident Fellow @AEI. Partner @NEA. Contributor @CNBC. 23rd Commissioner of the @US_FDA 2017 to 2019. @Pfizer @Illumina @AetionInc @TempusLabs

Jun 17, 2020 10:41 AM
copied to clipboard

THREAD: The professional staff of FDA’s device center advance an important new policy to facilitate pooled testing of Covid samples; which will help employers, colleges, schools and others enable more widespread asymptomatic screening to protect Americans https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-facilitating-diagnostic-test-availability-asymptomatic-testing-and

I wrote about pooled sampling here in the @WSJ. FDA’s new template and recommendations for conducting validation studies for screening asymptomatic individuals is an essential step in having the right public health surveillance tools in place for the fall. https://www.wsj.com/amp/articles/how-businesses-can-keep-employees-safe-from-coronavirus-11591560900

Testing of pooled samples allows us to efficiently test many people at once. Individual samples only need to be tested if the pooled test turns up a positive result.

FDA’s recommendations will help developers design studies to demonstrate how pooled samples testing can be effectively deployed where the suspected prevalence of covid-19 is low.

Under new FDA policy, the agency issued templates to help developers submit EUAs for asymptomatic screening and pooled sample testing. It’s another milestone in leadership of professional staff of CDRH, who’ve advanced many innovative, critical policies to expand Covid testing.