The Food and Drug Administration (FDA) has cleared the Visby Medical Sexual Health Test, a polymerase chain reaction (PCR) diagnostic test for the detection of sexually transmitted infections (STIs) caused by Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis in women.
The single-use, point-of-care test delivers results in under 30 minutes using patient-collected female vaginal swab specimens. The system includes the Visby Medical Sexual Health device, the Visby Medical power supply, the Visby Medical Vaginal Specimen Collection kit, and fixed-volume transfer pipettes.
The FDA clearance was based on data from a multicenter study (ClinicalTrials.gov Identifier: NCT04098900) that evaluated the performance of the Visby Medical Sexual Health Test in female participants 14 to 80 years of age. Among patients with evaluable results (n=1532), the test showed sensitivity of 97.6% (95% CI, 93.2-99.2) and specificity of 98.3% (95% CI, 97.5-98.9) for C. trachomatis (n=1457), sensitivity of 97.4% (95% CI, 86.5-99.5) and specificity of 99.4% (95% CI, 98.9-99.7) for N gonorrhoeae (n=1468), and sensitivity of 99.2% (95% CI, 95.5-99.9) and specificity of 96.9% (95% CI, 95.8-97.7) for T vaginalis (n=1449).
“By providing a prompt and accurate test result, the use of this test will lower the likelihood that an infected patient will develop pelvic inflammatory disease,” said Gary Schoolnik, MD, an infectious disease expert, Chief Medical Officer at Visby Medical, and Professor of Medicine at Stanford University. “It will expedite the treatment of that patient’s sexual partner, and it will reduce the spread of sexually transmitted infections overall.”
The test will only be available in CLIA-waived point-of-care settings.
- Visby Medical™ receives FDA clearance and CLIA waiver for second generation sexual health test for women. News release. Visby Medical. March 14, 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.
- Morris SR, Bristow CC, Wierzbicki MR, et al. Performance of a single-use, rapid, point-of-care PCR device for the detection of Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis: a cross-sectional study. Published online November 23, 2020. The Lancet Infectious Diseases. doi.org/10.1016/S1473-3099(20)30734-9
- Visby Medical Sexual Health Point-of-Care Instructions for Use. Visbymedical.com. Accessed March 14, 2023. https://www.visbymedical.com/sexual-health-test/Visby-Medical-Sexual-Health-Point-of-Care-Instructions-for-Use.pdf.