FDA clears Visby Medical's sexual health test

2020 08 06 00 13 1401 Neisseria Gonorrhoeae 400

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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