FDA grants clearance for fast, point-of-care STI test for women
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Key takeaways :
- This STI test from Visby Medical provides test results for chlamydia, gonorrhoeae and trichomonas in less than 30 minutes.
- The FDA clearance will allow women to receive test results in a single office visit.
The FDA has granted 501(k) clearance and a Clinical Laboratory Improvement Amendments waiver for a polymerase chain reaction diagnostic test to detect sexually transmitted infections in women, according to a press release.
Visby Medical’s second-generation sexual health test is an instrument-free platform using polymerase chain reaction technology to test for chlamydia, gonorrhoeae and trichomonas from a single sample collected by the patient. The a point-of-care test provides results in less than 30 minutes, which enables testing, conversations and treatment with clinicians in a single patient visit, according to the release.
“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,” Mark Medlen, senior vice president of operations at Visby Medical, said in the release.
According to the release, there is a significant unmet need to improve the accuracy and time-to-diagnosis in sexually transmitted infection (STI) testing, which can take 2 to 5 days or more to get results. STIs reached an all-time high for the sixth consecutive year, according to the CDC in April 2022, with almost a 30% increase in gonorrhea and chlamydia from 2015 to 2019, the release stated.
“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,” Gary Schoolnik, MD, infectious disease expert and chief medical officer at Visby Medical and professor of medicine at Stanford University, said in the release. “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.”