Visby Medical STI Test gets FDA Clearance

Visby Medical’s in-office test for sexually-transmitted infections (STIs) in women that delivers 97 percent accurate results in 30 minutes — not the usual two to five days with laboratory testing — just received FDA clearance, enabling diagnosis and treatment in the same office visit.

The San Jose, Calif.-based company’s instrument-free polymerase chain reaction (PCR) diagnostic was cleared by the FDA for detecting Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis.

The rapid test has a Clinical Laboratory Improvement Amendments (CLIA) waiver that allows its use in CLIA-waived point of care settings, enabling clinicians to make informed treatment decisions during a single visit, helping to reduce unnecessary antibiotic use as well as the number of patients lost to care, the company said.