FDA clearance has been granted to Visby Medical for an at-home, multi-virus PCR test covering flu and COVID-19, positioning the product as the first such assay cleared via 510(k). Visby’s test differentiates influenza A, influenza B and SARS-CoV-2 and is designed to deliver lab-quality sensitivity with a 30-minute result, paired with telehealth connectivity. The company framed the clearance as an expansion of access to molecular diagnostics for early antiviral decision-making. Visby also cited prior over-the-counter PCR clearances, including an STI assay authorized via de novo clearance in March 2025. The development was supported in part by BARDA funding under the US Department of Health and Human Services’ ASPR program, and Visby’s distribution partnerships include major testing and retail channels.