FDA has cleared Visby Medical’s at-home molecular test for flu and COVID-19, marking the first 510(k) clearance for a multi-virus OTC PCR assay. The Visby test differentiates influenza A, influenza B, and SARS-CoV-2 and provides results with a telehealth connection, with the company citing a 30-minute turnaround time. Visby said the assay is intended to support faster decisions on antiviral treatment such as oseltamivir or nirmatrelvir/ritonavir. The development was supported in part by a $12.3 million BARDA grant under HHS, reinforcing federal interest in expanding consumer access to high-sensitivity diagnostics.