COVID-19 case numbers may be plummeting, but demand for fast-acting and easily accessible PCR-quality diagnostics—for the coronavirus and beyond—shows no sign of slowing down.
Ready to meet that demand and continue expanding the potential of rapid PCR testing is Visby Medical, maker of a handheld diagnostic platform that has so far been adapted to test for COVID and a handful of sexually transmitted infections.
With an eye toward further developing the testing platform for other illnesses, drastically increasing its manufacturing capabilities and, ultimately, bringing the palm-sized testing device out of clinical settings and into the home, Visby has raised $100 million in series E funding.
Ping An Voyager Partners led the round, while the Healthcare of Ontario Pension Plan, Cedars-Sinai Medical Center, ND Capital, Artiman Ventures, Pitango Venture Capital, Blue Water Life Science Advisors, Nissim Capital and venture capitalist John Doerr also joined in.
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Visby said it will use the new financing to up its production capacity ten times over, growing from the current range of tens of thousands of tests per month to churn out hundreds of thousands of tests each month. It also plans to expand its testing slate, adding antimicrobial resistance panels and a combination diagnostic to test for COVID and the flu at the same time.
The funding will also spur Visby closer to its longtime goal of receiving regulatory clearance for at-home use of its testing platform.
“When we started Visby Medical in 2012, we set out to revolutionize patient care with fast PCR diagnostics, available to anyone, anywhere, at any time,” said CEO Adam de la Zerda, Ph.D., in a statement. “We’ve taken the first steps to deliver on that promise with the world’s first handheld, instrument-free, single-use PCR tests for bacterial and parasitic infections with our Sexual Health Click Test, and for viral infections with our COVID-19 test. We are thrilled to have incredible investors who believe in our vision.”
The series E brings Visby’s lifetime funding total to about $300 million, following a $70 million round it reined in during the early days of the COVID pandemic in April 2020—when it was still operating in stealth mode and under the moniker of ClickDiagnostics. The company has also received nearly $80 million in federal funding throughout the pandemic to support the development of its rapid PCR tests, with contributions from the National Institutes of Health’s RADx initiative and the U.S. Department of Health and Human Services.
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Visby’s testing devices for COVID and women’s sexual health feature a simple, three-button mechanism and must be plugged into a power outlet to run the test.
After a nasal swab sample has been mixed with the provided buffer solution, it’s transferred to a compartment behind the first button. Pushing all three buttons down activates the test, triggering an LED light that will flash when the results are ready, a process that takes approximately 30 minutes—significantly faster than many other PCR testing options.
The FDA issued an emergency use authorization for the COVID test to be used in CLIA-certified labs in September 2020, then followed that up in February 2021 with an OK for point-of-care use. The women’s STI test, meanwhile, was cleared by the FDA in August 2021 to test for chlamydia, gonorrhea and trichomoniasis.