Visby Medical has secured around $55m in its latest funding round, with the potential of reaching $65m, aiming to accelerate the launch and distribution of its at-home women's sexual health test.
The test recently received authorisation from the US Food and Drug Administration (FDA).
Spearheaded by Catalio Capital Management, the round also saw participation from current investors such as Cedars Sinai Medical Center, ND Capital, Blue Water Life Science Advisors, John Doerr and Pitango Ventures.
The test claims to be the first single-use, disposable polymerase chain reaction (PCR) diagnostic that provides results in under 30 minutes via a connected smartphone app.
This technology not only improves healthcare accessibility but also maintains patient privacy.
The product is set to be available to consumers as of next month through direct-to-consumer channels.
Visby also announced that Catalio partner Isaac Ro will join its board as an observer.
Moreover, Chuck Alpuche, who currently serves as the chief operating officer (COO) at Imperative Care, will join as an independent director to the board of Visby.
Visby Medical CEO and founder Adam de la Zerda said: "We are excited to partner with Catalio Capital Management, a true industry powerhouse, as we advance our mission to transform healthcare through rapid and convenient at-home diagnostics that deliver the same accuracy as traditional PCR machines.
"This funding round will enable Visby to deliver on our vision of empowering consumers with reliable and lab-accurate health information from the comfort of their homes, starting with our at-home test for sexually transmitted infections (STIs) for women."
Founded in 2012, Visby focuses on infectious disease diagnosis, enabling both physicians and patients to test for infections with lab accuracy.
The company's portfolio includes the tests cleared by the US regulator for STIs for point-of-care and home use, as well as for respiratory infections such as Covid-19, flu A, and flu B.
Earlier this year, the FDA granted 510(k) clearance and a Clinical Laboratory Improvement Amendments (CLIA) waiver for Visby’s PCR test to detect respiratory infections.
