Visby Medical’s over the counter (OTC) combination PCR test for Covid-19 and influenza A/B detection has secured US Food and Drug Administration (FDA) clearance, providing patients with an at-home test designed to detect the respiratory viruses earlier.
The California-based company’s multi-viral Visby Medical Flu and Covid-19 test yields results in 30 minutes. PCR testing is generally considered higher power compared to rapid antigen tests, though the latter became a popular detection method during the Covid-19 pandemic due to their accessibility. PCRs have traditionally required lab processing, making Visby’s at-home, rapid platform an important advancement for viral testing.
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Meanwhile, the earlier detection for these conditions is widely considered to be important given that antiviral medications for their treatment are viewed to be most effective when started early on in the course of infection.
The development of Visby’s next generation test was supported by a $12.3m grant from the US Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA), in 2021. The FDA previously granted Visby an emergency use authorisation (EUA) for its previous rapid RT-PCR assay for detecting Covid at the height of the Covid pandemic in September 2020.
Visby’s latest PCR test clearance builds on the March 2025 FDA authorisation for its PCR STI test for chlamydia, gonorrhoea, and trichomoniasis.
Visby’s CMO, Gary Schoolnik, said: “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.”
According to a duo of GlobalData market models, in 2035, the global influenza and Covid-19 test markets will reach valuations of around $263m and $4.3bn, respectively.
