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Visby Medical Point-of-Care STI Test Gets FDA 510(k) Clearance, CLIA Waiver

NEW YORK – Visby Medical said on Tuesday that it has received 510(k) clearance and a CLIA waiver from the US Food and Drug Administration for its second-generation point-of-care sexual health test.

The Visby Medical Sexual Health test uses PCR to detect sexually transmitted infections caused by Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis in women, the company said in a statement. It provides results in less than 30 minutes and has about 97 percent accuracy, Visby added. The new version of the test has improvements in workflow, manufacturability, and reliability compared to the original device, which received FDA clearance in 2021.

The new clearance will allow Visby to move production to its fully automated manufacturing lines, Visby Senior VP of Operations Mark Medlen said in a statement. 

"Providing more customers with access to the Visby platform will enable clinicians to make informed treatment decisions during the span of a single clinic visit," added Visby Chief Medical Officer Gary Schoolnik. "This will help reduce overtreatment and undertreatment rates, as well as the number of patients who are lost to care."