Visby Medical received U.S. FDA 510(k) clearance for an at-home PCR test that detects and distinguishes influenza A, influenza B, and SARS-CoV-2, with results reported in about 30 minutes. The company said the test is paired with telehealth access to support treatment decisions. Visby positioned the clearance as an expansion of its consumer-access strategy after it previously received FDA clearance for an at-home sexually transmitted infections assay. The new development drew partial support from BARDA under HHS, which provided $12.3 million for test development. For biotech and diagnostics companies, the authorization highlights ongoing commercialization of home-based molecular testing, particularly in respiratory infections where timely antiviral treatment can affect outcomes. It also reinforces demand for rapid, high-sensitivity lab-style diagnostics outside traditional clinical settings.