FDA Plans Pathway For COVID-19 Tests That Detect And Sequence Virus

FDA plans to issue recommendations for how diagnostics developers can seek emergency use authorization for dual-purpose COVID-19 tests that can both diagnose the disease and report to patients whether the strain detected is a variant, Timothy Stenzel, director of FDA’s office of in vitro diagnostic and radiological health, said during a Wednesday (April 28) stakeholder call. The agency currently has an EUA pathway available for dual-purpose tests that only report variant information to public health officials, but Stenzel said there...