Visby Medical has received 510(k) clearance and was granted a CLIA waiver from the U.S. Food and Drug Administration (FDA) for its second generation point-of-care test: the Visby Medical Sexual Health test
The Visby Medical Sexual Health test is a fast, PCR diagnostic test for the detection of sexually transmitted infections (STIs) caused by Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis in women.
Visby Medical’s “instrument-free” platform features a CLIA-waived, sexual health POC test, which provides accurate results in under 30 minutes, enabling clinicians to test, talk, and accurately treat in a single patient visit. Featuring a new design, the test turns four actions into one while maintaining about 97% accuracy. This new device delivers significant improvements in workflow, manufacturability, and reliability compared to its predecessor, the company says.
“We are excited that the clearance of the second generation Sexual Health Test will enable us to move production to our fully automated lines, allowing us to deliver more tests to eagerly waiting customers,” says Visby Medical Senior Vice President of Operations Mark Medlen. There is a significant unmet need to improve accuracy and time-to-diagnosis in STI testing, which often takes two to five days or more to return results. In April 2022, the Centers for Disease Control and Prevention reported that STIs have reached an all-time high for the sixth consecutive year, with a nearly 30% increase in gonorrhea and chlamydia between 2015 and 2019.
Gary Schoolnik, MD, an infectious disease expert, chief medical officer at Visby Medical, and professor of medicine at Stanford University, added: “Providing more customers with access to the Visby platform will enable clinicians to make informed treatment decisions during the span of a single clinic visit. This will help reduce overtreatment and undertreatment rates, as well as the number of patients who are lost to care. 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. It will expedite the treatment of that patient’s sexual partner, and it will reduce the spread of sexually transmitted infections overall.”