FDA yanks EUA for serology test

Regulatory NewsRegulatory News | 17 June 2020 |  By 

The US Food and Drug Administration (FDA) on Tuesday revoked the emergency use authorization (EUA) granted to Chembio Diagnostic Systems Inc. for its DPP COVID-19 IgM/IgG System based on several sets of data indicating that the test generates false results at a higher rate than expected. This is the first revocation of an EUA for a SARS-CoV-2 serology test during the COVID-19 public health emergency.

The system in question is an antibody test for the novel coronavirus; it was authorized to be used with serum and plasma, venous whole blood or fingerstick whole blood by healthcare providers in patients with suspected coronavirus disease (COVID-19). At the time of authorization on 14 April 2020, Chembio provided specific clinical performance data allowing FDA to determine that known and potential benefits of the system outweighed known and potential risks of use.

To better ascertain the performance capabilities of COVID-19 antibody tests, FDA has partnered with the National Cancer Institute (NCI) at the National Institutes for Health (NIH) to develop general performance expectations for these tests and has incorporated those expectations in its serology templates, according to a statement from the agency.

Analysis by NCI laboratories, as well as data requested by FDA and submitted by Chembio indicated that the test in question provided both high false positive rates and high false negative rates, Denise M. Hinton, FDA Chief Scientist, wrote in the revocation letter, adding that proposed modifications to the test did not result better performance.

“Given the poor device performance observed in multiple evaluations since authorization described above, FDA has concluded it is not reasonable to believe the product may be effective in detecting antibodies against SARS-CoV-2 or that the known and potential benefits of your device outweigh its known and potential risks,” Hinton wrote. “In addition, based on the same information and the risks to public health from false test results, FDA has concluded under section 564(g)(2)(C) that other circumstances make revocation appropriate to protect the public health or safety.”

"Since the beginning of the COVID-19 public health emergency, the FDA has balanced the urgent need for access to diagnostic and antibody tests with providing a level of oversight that helps to ensure accurate tests are being deployed," Jeff Shuren, MD, director of FDA Center for Devices and Radiological Health, said in a statement. "By continuing to monitor authorized tests and emerging scientific evidence, we are able to make changes when appropriate – including taking action when a test's benefits no longer outweigh its risks. Through these efforts, we are able to help assure that FDA-authorized tests meet the needs of the American public."

EUA Revocation


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