FDA clears Visby Medical's sexual health test

By LabPulse.com staff writers

August 30, 2021 -- The U.S. Food and Drug Administration (FDA) has cleared Visby Medical's Sexual Health Click test, a polymerase chain reaction test for identifying Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis.

The agency has also granted Visby Medical a waiver under CLIA for the test, the company said. The CLIA waiver allows facilities with CLIA certification to administer the test during a patient's appointment. The test is performed using a self-collected vaginal swab, and results are ready within 30 minutes.

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Last Updated ls 8/30/2021 2:38:37 PM