FDA approves Visby Medical ™ handheld STI testing device

The U.S. Food and Drug Administration (FDA) has issued 501(k) clearance for Visby Medical’s Sexual Health Click Test, a single-use, instrument-free polymerase chain reaction (PCR) diagnostic test for sexually transmitted infections (STI).

The device can detect 3 of the most common STIs—Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV)—in less than 30 minutes via a self-collected vaginal swab.

The FDA also granted a waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), allowing any health care setting with a CLIA Certificate of waiver to administer the test during the patient’s appointments. This eliminates the need to send samples to a laboratory and reduces the time needed to obtain the results. It also may be useful in areas with limited access to testing.

“Without an accurate test result, we are fighting blind, often prescribing STI treatments before we have a clear diagnosis, which can lead to delayed or ineffective treatment and to the emergence of antibiotic-resistant microbes, Gary Choolnik, MD, an infectious disease expert, Visby Medicals’ Chief Medical Officer, and Professor of Medicine at Stanford University said in a recent press release.