Visby Medical Receives FDA Clearance for the First At-Home PCR for Multiple Respiratory Viruses

The Visby Medical Flu and COVID-19 Test Combines Lab-Quality Sensitivity with Immediate Telehealth Connection

SAN JOSE, Calif.--(BUSINESS WIRE)--Visby Medical, the at-home diagnostics company, today 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.

“Just over a year after the authorization of our first at-home PCR test, we’re expanding the same gold-standard PCR accuracy and 30-minute result to some of the most common respiratory infections,” said Adam de la Zerda, founder of Visby Medical. “With the Visby Medical Flu and COVID-19 Test, consumers can test themselves at home, receive a real PCR result in 30 minutes, and make faster, more informed decisions about treatment and care.”

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 represents a meaningful advancement in access to highly sensitive molecular diagnostics for consumers,” said Gary Schoolnik, Chief Medical Officer of Visby Medical. “More sensitive testing can help more patients access treatment during the window when antivirals are most effective, which can meaningfully impact outcomes for respiratory infections like COVID-19 and influenza.”

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.

Over the past year, Visby has significantly expanded access to its at-home testing platform, with its STI test now available nationwide through partners including DoorDash, Labcorp, Quest Diagnostics, Wisp, Everlywell, and RAINN.

This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50121C00019.

About Visby Medical
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. For more information, visit visby.com. Follow Visby Medical on LinkedIn.