Developers of antibody tests for SARS-CoV-2 now must seek Emergency Use Authorization for their tests from the US Food and Drug Administration, as GenomeWeb reports.
Previously, the agency had only required that companies affirm their tests are valid and label them as unapproved, Reuters writes, noting that the agency had at that time been "under pressure to move fast" following the slow introduction of diagnostic SARS-CoV-2 tests. But Politico reported last week that a number of antibody tests on the market are not accurate. Reuters additionally reported last week that this laissez-faire approach opened the door to fraudsters.
"Flexibility never meant we would allow fraud," Anand Shah, FDA's deputy commissioner for medical and scientific affairs, and Jeff Shuren, director of the Center for Devices and Radiological Health, write in a statement posted to the FDA site. "We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans' anxiety."
Under the new guidance issued by FDA, antibody test developers must file for an Emergency Use Authorization and provide certain validation data.