FDA Clears First At-Home PCR for Multiple Respiratory Viruses

Visby Medical has secured U.S. Food and Drug Administration (FDA) clearance for the Visby Medical Flu and COVID-19 Test, the first multi-viral at-home PCR assay. The test is Visby’s second over-the-counter PCR check and expands the company’s portfolio of rapid molecular diagnostics designed for home use.

The clearance coincides with the growth of at-home testing, particularly for respiratory infections like COVID-19 and influenza. Designed for home use, the Visby Medical Flu and COVID-19 Test allows people to quickly test for COVID-19 and influenza A/B so they can make faster care decisions, 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,” Visby Medical Founder Adam de la Zerda said. “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 assays, PCR testing can detect infections earlier and at lower viral levels, making it the gold standard for diagnosing respiratory infections such as COVID-19 and influenza. Earlier detection is especially important because antiviral medications such as Paxlovid and Tamiflu are most effective when started early during infection.

“The Visby Medical Flu and COVID-19 Test represents a meaningful advancement in access to highly sensitive molecular diagnostics for consumers,” Visby Medical Chief Medical Officer Gary Schoolnik stated. “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 will be eligible for FSA and HSA reimbursement, consistent with Visby’s currently available at-home testing product.

Over the past year, Visby has 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 U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; and the Biomedical Advanced Research and Development Authority (BARDA).

Founded in 2012, Visby Medical is attempting to revolutionize 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 the hand. Visby Medical is actively expanding its platform with a wide range of future tests for the at-home and point-of-care markets.