FDA authorizes new COVID-19 antibody test’s use, accelerates approval for cancer therapy

The Food and Drug Administration this week issued an emergency use authorization for Abbott Laboratory’s SARS-CoV-2 IgG assay for the qualitative detection of COVID-19 antibodies.

FDA said that the test may be effective in diagnosing recent or prior infection with SARSCoV-2 by identifying individuals with adaptive immune responses to the virus that causes COVID-19.

FDA also granted accelerated approval for a new dosing regimen for a cancer therapy that allows patients with certain cancers to continue treatment with fewer in-person visits. The approval was granted more than five months prior to the agency’s goal date.