Although COVID-19 cases seem to be flagging for the time being, the lengthy pandemic has elucidated the widespread need for fast-acting PCR-quality diagnostic tests—and not only for COVID evaluations. Visby Medical, which makes a handheld diagnostic platform that has been augmented to handle testing for COVID-19 as well as a number of sexually transmitted diseases, is rising to the challenge with support from a lucrative fundraising round.
Visby’s $100 million Series E funding brings its lifetime funding haul to $300 million, adding to a $70 million round from COVID-19’s nascent period in April 2020 and roughly $80 million in federal contributions for rapid PCR test development from the National Institutes of Health’s RADx initiative and the U.S. Department of Health and Human Services.
The new money will help Visby beef up its manufacturing capabilities ten times over, ready its device for an upcoming regulatory clearance push for out-of-clinic home use, and add new coverage such as antimicrobial resistance panels and a COVID/flu combination test to its platform. The round’s leader was Ping An Voyager Partners; notable participants included Cedars-Sinai Medical Center, Nissim Capital, and Venture Capitalist John Doerr.
The FDA granted the device an emergency use authorization in mid-2020 for COVID testing in CLIA-certified labs, which was followed by a green light for point-of-care use in February of last year. The women’s STI test received an FDA okay in August 2021 for chlamydia, gonorrhea, and trichomoniasis testing.