Visby Medical has received the US Food and Drug Administration 510(k) approval and CLIA waiver for its second-generation Sexual Health point of care (POC) test for women.
The rapid, polymerase chain reaction (PCR) diagnostic test is designed to detect sexually transmitted infections (STIs) caused by Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis in women.
Visby Medical said its Sexual Health test for women is the first and only instrument-free platform that fits in a person’s palm and offers true PCR technology.
The CLIA-waived POC test provides accurate results within 30 minutes, allowing clinicians to test, talk and provide treatment in a single patient visit.
Visby Medical operations senior vice president Mark Medlen 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.”
Visby said that 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.
According to the Centers for Disease Control and Prevention (CDC) report in April last year, STIs have reached an all-time high for the sixth consecutive year. Gonorrhoea and chlamydia cases increased by nearly 30% between 2015 and 2019.
The company said that its new-generation test comes with a sleek design, and turns four actions into one, while maintaining about 97% accuracy.
Its new device delivers significant improvements in workflow, manufacturability, and reliability compared to its predecessor, said Visby.
Visby Medical chief medical officer and infectious disease expert Gary Schoolnik said: “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 the pelvic inflammatory disease.”
