Visby Medical has secured FDA clearance for an over-the-counter, at-home PCR test that detects SARS-CoV-2 and influenza A/B with results in about 30 minutes. Backed by a $12.3 million BARDA grant, the device brings lab-grade molecular sensitivity into the home, potentially enabling earlier antiviral treatment. The clearance follows Visby’s 2020 EUA for a Covid RT-PCR assay and a March 2025 FDA clearance for a PCR STI test. Market projections suggest continued demand for these diagnostics through 2035.
FDA Clears Visby Medical's At-Home OTC PCR Test for Covid-19 and Influenza A/B
Visby Medical has received Food and Drug Administration (FDA) clearance for an over-the-counter (OTC), at-home combination PCR test that simultaneously detects SARS-CoV-2 (Covid-19) and influenza A/B. Marketed as the Visby Medical Flu and Covid-19 Test, the compact device returns molecular results in roughly 30 minutes, bringing laboratory-grade sensitivity into the home and other point-of-care settings.
Faster, More Sensitive At-Home Molecular Testing
Unlike rapid antigen tests, which became widely used during the Covid-19 pandemic for convenience, PCR assays are generally more sensitive. PCR tests traditionally required central laboratory processing; Visby’s platform packs rapid RT-PCR capability into a portable, user-friendly device, representing an important shift in access to high-sensitivity diagnostics.
Clinical and Public Health Importance
Early detection of Covid-19 and influenza is clinically significant because approved antiviral treatments are most effective when started early in the course of infection. By enabling earlier identification at home, the Visby test can help patients and clinicians make timelier treatment and isolation decisions.
Development And Regulatory Context
The next-generation assay development was supported by a $12.3 million grant from the US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) awarded in 2021. Visby previously received an emergency use authorization (EUA) for an earlier rapid RT-PCR Covid-19 assay in September 2020, and in March 2025 the company earned FDA clearance for a separate PCR-based STI test that detects chlamydia, gonorrhea and trichomoniasis.
“The Visby Medical Flu and Covid-19 Test represents a meaningful advancement in access to highly sensitive molecular diagnostics for consumers,” said Gary Schoolnik, Visby’s Chief Medical Officer. “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.”
Market Outlook
According to GlobalData market models, by 2035 the global influenza testing market could be worth about $263 million, while the Covid-19 testing market may reach roughly $4.3 billion, underscoring ongoing demand for improved diagnostic tools.
Note: This information is provided for general informational purposes. Individuals should consult healthcare professionals for medical advice or treatment decisions based on test results.
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