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Visby Medical Obtains FDA 510(k), CLIA Waiver for Multiplex STI Test Using Handheld PCR Device

NEW YORK – The US Food and Drug Administration has granted 510(k) clearance and a CLIA waiver to a multiplex assay from Visby Medical to detect Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. The assay uses an instrument-free, single-use PCR device.

The Visby Medical Sexual Health Click Test provides results in less than 30 minutes from a self-collected vaginal swab.

A clinical trial published in The Lancet Infectious Diseases last year showed the test had high sensitivity and specificity compared to lab-based testing.

The CLIA waiver now enables any healthcare setting with a CLIA certificate of waiver to run the test and provide results during a patient's appointment, the San Jose, California-based firm said.

"Empowering clinicians with immediate access to a lab-grade PCR result will help guide not just the right treatment, but also the right patient discussion during that single patient visit," said Visby's chief medical officer, Gary Schoolnik, in a statement.

Adam de la Zerda, founder and CEO of Visby Medical, said the FDA clearance and CLIA waiver further validate the firm's technology. "Accurate results can ensure the clinician is able to make informed decisions that can shorten infection duration, prevent transmission, and may lower the risk of complications, all while improving the patient and clinician experience," he said.

Visby obtained Emergency Use Authorization for a SARS-CoV-2 assay that uses the same handheld PCR system in February and has also been awarded a contract worth $12.3 million from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority to develop a handheld diagnostic for SARS-CoV-2 and influenza.