


Visby Medical has been granted US FDA clearance for a new OTC at-home COVID-19 and influenza A/B combo molecular test
US-based diagnostics company Visby Medical has been granted US FDA clearance for a new OTC at-home COVID-19 and influenza A/B combo molecular test.
This will become the second molecular test available on the U.S. market — the sole option now being Aptitude Medical’s Metrix platform following the exit of Cue, Lucira, and 3EO in recent years.
This test will be single-use (disposable), and fully integrated, so following the Lucira model instead of the Metrix/Pluslife model with a reusable reader. However, it will be powered via USB-C cable instead of batteries like Lucira. It will be nasal swab only, requires a mobile app, and results will be available in 30 minutes.
The Visby test boasts a much lower Limit of Detection than Metrix’s combo test:
- Visby SARS2: 20 copies/swab
- Metrix SARS2: 500 GE/swab
- Visby Influenza: 90-270 copies/swab
- Metrix Influenza: 1,000-2,000 GE/swab
However, the clinical sensitivity still ended up being roughly equivalent to Metrix )actually very slightly lower, but the confidence intervals sort of make that a moot point):
- Visby SARS2: 93.6%
- Visby Flu A: 92.0%
- Visby Flu B: 94.4%
- Metrix: 95.2% to 95.8% for all three
This test has been in development since 2021 when Visby received a $12.3M grant from HHS’s BARDA, and is subsequent to Visby’s OTC STI panel (FDA authorized 2025) and point-of-care PCR COVID-19 test (EUA September 2020).
As far as I’m aware, no information is available yet on distribution channels, availability, or pricing.
FDA documents: