FDA gives clearance and CLIA waiver to second generation sexual health test

The FDA has given 510(k) clearance and a CLIA waiver to Visby Medical’s second generation point of care (POC) test for identifying sexually transmitted infections (STIs) caused by Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis in women.

STIs reached an all-time high for 6 years in a row in 2022, but STI testing often has a 2 to 5 day or more time-to-diagnosis. Additionally, gonorrhea and chlamydia alone saw a 30% increase from 2015 to 2019.

The Visby Medical Sexual Health POC test is the first “instrument-free” platform offering true polymerase chain reaction technology and is small enough to fit in the palm of one’s hand. It allows accurate test results to be determined in under 30 minutes, giving clinicians the opportunity to accurately test, talk, and treat patients in a single visit.

Significant improvements in workflow can be granted from the device, which turns 4 actions into 1 with 97% accuracy. Manufacturability and reliability are also improved from the previous model.

According to Gary Schoolnik, MD, chief medical officer at Visby Medicaland professor of medicine at stanforduniversity, the Visby platform will allow clinicians to make informed decisions on treatment in 1 visit. It will also reduce the risk of pelvic inflammatory disease in an infected patient, expedite the treatment of patients’ sexual partners, and lessen the spread of STIs.

"Fast and accurate results mean we can usually keep our 'door to discharge time' under 1 hour—patients have a convenient, complete engagement, and we can provide appropriate care without the risk of unnecessary antibiotics that can happen when a definitive diagnosis is delayed,” said Lamont Tyler, MD, market medical director of CareNow Urgent Care Henderson, Nevada.

Reference

Visby Medical receives FDA clearance and CLIA waiver for second generation sexual health test for women. Visby Medical. March 14, 2023. Accessed March 21, 2023. https://www.prnewswire.com/news-releases/visby-medical-receives-fda-clearance-and-clia-waiver-for-second-generation-sexual-health-test-for-women-301771495.html