Congressional Leaders Seek Coronavirus Test Information from FDA

In a letter to FDA Commissioner Stephen Hahn, representatives Lloyd Doggett (D-Texas) and Rosa DeLauro (D-Connecticut) specifically requested details about sensitivity and specificity data the FDA has received from test makers, how the FDA is handling these data, and information on which labs are meeting regulatory guidelines.

“We request an update on the current status of information provided to the FDA about the accuracy of the COVID-19 tests of which the FDA has been notified and whether or not each included a completed EUA,” Doggett and DeLauro wrote to Hahn.

This includes a list of labs that have submitted sensitivity and specificity data on their tests; all sensitivity and specificity information the FDA has received from these labs; information or concerns received from non-lab sources about the accuracy of SARS-CoV-2 tests; a list of FDA actions taken in response to submitted performance data; and a list of labs that have failed to meet the 15 business day deadline and steps the FDA has taken to obtain required information.

Source: https://www.genomeweb.com/molecular-diagnostics/congressional-leaders-seek-coronavirus-test-information-fda