First COVID neutralizing antibody test okayed by FDA

FDA said Friday it has granted an emergency use authorization (EUA) to the first commercial laboratory test to detect neutralizing antibodies against the novel coronavirus. Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health, said: “The ability to detect neutralizing antibodies can help us gain additional insight into what the existence of antibodies may mean for patients as we continue the fight against COVID-19.” Monoclonal antibodies that neutralize the increase in protein on SARS-CoV-2 are being examined as possible therapeutic agents for COVID-19 infection. Neutralizing antibody titers are a critical measure that vaccine researchers and regulators track as a marker to determine the immunogenicity of COVID-19 vaccine candidates. To date, FDA granted EUAs to more than 50 serology tests for COVID-19 antibodies, which all detect binding antibodies rather than the neutralizing antibodies the new test detects. In both instances, the tests help to show whether an individual has had recent or prior infection with SARS-CoV-2. Stenzel cautioned, “Patients should not interpret results as telling them they are immune, or have any level of immunity, from the virus.”