On Jul. 2, 2026, Visby Medical, the at-home diagnostics company, announced U.S. Food and Drug Administration (FDA) clearance for the Visby Medical Flu and COVID-19 Test, the first multi-viral at-home PCR test. This marks Visby’s second over-the-counter PCR test and expands the company’s growing portfolio of rapid molecular diagnostics designed for home use.

The clearance comes as demand for at-home testing continues to grow, particularly for respiratory infections like COVID-19 and influenza, which send millions of people to urgent care each year. Designed for home use, the Visby Medical Flu and COVID-19 Test helps consumers quickly test for COVID-19 and influenza A/B so they have the test results to enable faster decisions about care, including whether to seek antiviral treatment or connect with a telehealth provider.

Unlike antigen tests, PCR testing can detect infections earlier and at lower viral levels, making it the gold-standard for diagnosing respiratory infections like COVID-19 and influenza. Earlier detection is especially important because antiviral medications such as Paxlovid and Tamiflu are most effective when started early in the course of infection.

The Visby Medical Flu and COVID-19 Test builds on Visby’s previously authorized at-home testing platform and further expands the company’s growing over-the-counter diagnostics portfolio. It will be eligible for FSA and HSA reimbursement, consistent with Visby’s currently available at-home testing product.

Founded in 2012, Visby Medical is revolutionizing infectious disease diagnosis by empowering both physicians and patients to accurately test for infections anywhere, anytime, with laboratory accuracy. The company’s proprietary technology platform delivers true PCR results in 30 minutes through the world’s first instrument-free, single-use PCR tests that fit in the palm of your hand. Visby Medical is actively expanding its platform with a wide range of future tests for the at-home and point-of-care markets