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Congressional Leaders Seek Coronavirus Test Information From FDA

NEW YORK — Lawmakers on Thursday called on the US Food and Drug Administration to provide information about the accuracy of the various SARS-CoV-2 diagnostics being used in response to the ongoing pandemic.

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.

"Accurate COVID-19 testing is essential to reducing the spread of this deadly virus and getting our society and economy back on track in the months ahead," DeLauro said in a statement. "While it is imperative that testing becomes widespread, FDA needs to do its part to ensure people are getting accurate results, as well as address any mistakes that have been made to date."

Doggett is chairman of the House Ways and Means Health Subcommittee. DeLauro chairs the Labor, Health and Human Services, and Education Appropriations Subcommittee.

In their letter, Doggett and DeLauro cited problems with the first SARS-CoV-2 test kits that were provided by the US Centers for Disease Control and Prevention at the beginning of the outbreak. The kits, which had received Emergency Use Authorization (EUA) from the FDA in early February, were later found to be providing inconclusive results during the quality control process, requiring the remanufacture of certain reagents.

In late February, the FDA began allowing high-complexity CLIA-certified labs to immediately perform SARS-CoV-2 tests that had been developed and tested in house while they pursue EUA. 

Shortly thereafter, the FDA expanded its enforcement discretion over local labs and test kit manufacturers to allow them to perform SARS-CoV-2 testing with limited federal oversight, and released guidance requiring test makers to provide the agency with a completed EUA request and related data to demonstrate assay validity within 15 business days.

"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.