At-Home PCR Test Detects Flu and COVID-19 in 30 Minutes

With growing consumer use of at-home tests, rapid, reliable results can help speed access to antivirals that work best when started early. 

Visby Medical (San Jose, CA, USA), an at-home diagnostics company, announced today that it has received U.S. Food and Drug Administration (FDA) clearance for its Flu and COVID-19 Test, positioned as the first at-home PCR test designed to detect multiple respiratory viruses. The over-the-counter assay is intended for home use and helps individuals quickly determine whether they have SARS-CoV-2 or influenza A/B. The test combines lab-quality sensitivity with an immediate telehealth connection, enabling users to act on results without delay.

The system uses PCR to detect infections earlier and at lower viral levels than antigen methods, providing a 30-minute turnaround time for a “real PCR result.” Early detection is positioned to support faster clinical decisions, including whether to initiate antivirals such as those used for COVID-19 and influenza, and whether to connect with a virtual care provider. The test’s home-use design aims to streamline decision-making while maintaining molecular accuracy.

Regulatory clearance from the U.S. FDA establishes the assay as Visby Medical’s second over-the-counter PCR product. The test will be eligible for flexible spending account and health savings account reimbursement, consistent with the company’s current at-home offering. The clearance expands the company’s portfolio of rapid molecular diagnostics designed specifically for home settings.

Visby Medical reports broader access to its home-based testing platform over the past year, with its sexually transmitted infection test offered through national partners including DoorDash, Labcorp, Quest Diagnostics, Wisp, Everlywell, and RAINN. The project has received support in whole or in part 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).

“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. 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,” said Adam de la Zerda, founder of Visby Medical.

“The Visby Medical Flu and COVID-19 Test represents a meaningful advancement in access to highly sensitive molecular diagnostics for consumers. 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,” stated Gary Schoolnik, Chief Medical Officer of Visby Medical.