FDA clears Visby Medical ‘game-changing’ STI test

The US testing company Visby Medical has received FDA clearance for its “second generation” sexual health test for women.

The company has announced it received 510(k) clearance and was granted a CLIA waiver from the US FDA for its point of care (POC) test.

The product, which aims to help clinicians accurately test and treat patients in a single visit, is a fast, 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.

Although many STIs are preventable, there are more than 20 million estimated new cases in the United States each year.

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 per cent increase in gonorrhoea and chlamydia between 2015 and 2019.

“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,” said Dr Gary Schoolnik, an infectious disease expert and chief medical officer at Visby Medical.

“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 STIs overall.”

Mark Medlen, Visby Medical senior vice president of operations, said: “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.”

Dr Denise Sweeney of Associates in Women’s Healthcare, an OB-GYN practice from Roseville, California, said the test has been “game-changing”.

“My patients come in, self-collect and get answers in the same visit,” she added.

“We’ve simplified our workflow with reduced need to chase down patients for results and pharmacy preferences and we spend less time reviewing lab results. All this has really led to a lot of satisfaction in our office.”