Visby Medical received 510(k) clearance for an at-home multiplex PCR test for flu and COVID-19, expanding consumer-access molecular testing beyond its earlier home STI assay authorization. The test distinguishes influenza A, influenza B, and SARS-CoV-2 and is designed to deliver lab-quality sensitivity with results in about 30 minutes, paired with telehealth connectivity. The company said early antiviral treatment needs timely diagnosis, pointing to use cases for antivirals such as Paxlovid and Tamiflu. It also cited support from BARDA through a $12.3 million HHS contract for test development. The clearance marks another step in building at-home diagnostic infrastructure, with implications for how clinicians manage respiratory infection triage and follow-up care.