The Visby Medical Women’s Sexual Health Test’s de novo authorisation was supported by a study of 2,000 users in which it achieved high accuracy ratings for each of the STIs it tests for. Image credit: Tada Images via Shuttestock.
The US Food and Drug Administration (FDA) has authorised the first at-home PCR STI test for chlamydia, gonorrhoea, and trichomoniasis.
Intended for use by women with or without symptoms, Visby Medical’s diagnostic test can be purchased over-the-counter (OTC) without a prescription and performed at home.
Supplied with a vaginal swab and handheld PCR test device, the single-use test is designed to communicate with Visby’s smartphone app to display test results within 30 minutes.
Reviewed under the FDA’s de novo premarket pathway, the test’s authorisation was supported by a study of 2,000 users. The data showed that the test correctly identified 98.8% of negative and 97.2% of positive chlamydia trachomatis samples, 99.1% of negative and 100% of positive Neisseria gonorrhoeae samples, and 98.5% of negative and 97.8% of positive Trichomonas vaginalis samples.
Last year, NOWDiagnostics’ First To Know became the first OTC test in the US to inform a user about a potential syphilis infection.
Courtney Lias, director of the office of in vitro diagnostic devices in the FDA’s Center for Devices and Radiological Health, said at-home STI tests can be especially beneficial in mitigating patients’ anxiety around getting tested, which can delay diagnosis and treatment.
Lias commented: “Expanding access to tests for STIs is an important step towards earlier and increased diagnosis, which can result in increased treatment and reduced spread of infection.”
A report by the US Centers for Disease Control and Prevention found that more than 2.2 million cases of chlamydia and gonorrhoea were diagnosed and reported in the US in 2023. Meanwhile, trichomoniasis, the most prevalent nonviral STI worldwide, affects approximately 2.6 million individuals in the US.
Visby Medical chief medical officer Gary Schoolnick commented: “Many patients infected with these STIs are non-symptomatic, yet they can still suffer serious long-term health consequences. Our test directly addresses this silent epidemic by enabling detection and treatment.”
Visby CEO Adam de la Zerda said the FDA’s authorisation primed it for “significant expansion” into the at-home diagnostics market and revealed that the company plans to introduce additional OTC tests for respiratory infections, sore throat conditions, urinary tract infections (UTI), and other common illnesses in the future.
With Visby’s de novo authorisation, the FDA revealed that the action creates a “new regulatory classification”.
Elaborating further, the agency stated: “Subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket notification process, whereby devices can obtain marketing authorisation by demonstrating substantial equivalence to a predicate device, which may save a developer time and expense compared to other review pathways.”
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