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
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.”
