POC Diagnostic Platform Offers Handheld, Instrument-Free PCR Testing for STIs

Visby Medical’s (San Jose, CA, USA) fast, single-use polymerase chain reaction (PCR) diagnostic test is intended for the multiplexed detection of STIs caused by Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV), using a self-collected vaginal swab with about 97% or greater accuracy. With the capability to detect three of the most common and treatable STIs, Visby’s Sexual Health Click Test is uniquely positioned to address women’s health needs and promote positive health outcomes.

The test offers PCR technology in palm-sized dimensions and provides accurate results in less than 30 minutes, with no additional instruments required. Patients provide a vaginal swab self-collected in privacy, and then receive results and proper treatment during the same visit, eliminating typical wait time. Generally, clinicians have to wait 24 to 48 hours after specimen collection to receive results, which commonly leads to patients being lost to follow-up. With the Visby device, patients can be tested, counseled, and treated during a single visit, all patients will receive the treatment they need, and none will be lost to follow-up.

With its highly accurate results, the Sexual Health Click Test reduces unnecessary over- and under-treatment and accelerates time to receive treatment, therefore decreasing the possibility of transmission and complications due to lack of, or improper, treatment. Immediate results during the patient visit also offer the opportunity to educate patients about STI prevention and risk reduction. Visby has been granted a 510(k) clearance and CLIA Waiver by the US Food and Drug Administration (FDA) to market its Sexual Health Click Test. The FDA-granted CLIA Waiver allows any healthcare setting with a CLIA Certificate of Waiver to administer the test during the patient’s appointment, eliminating the need to send specimens to a laboratory, and greatly reducing the time between initial testing and treatment. Use of the device could significantly reduce growing STI rates, especially in communities with limited access to testing.

“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. This can help save time, money, and reduce anxiety for the patient and clinician alike, enabling expedited partner treatment,” said Gary Schoolnik, MD, an infectious disease expert, Chief Medical Officer at Visby Medical, and Professor of Medicine at Stanford University

“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,” added Visby Medical Founder and CEO, Adam de la Zerda, PhD, who is also Associate Professor at Stanford University School of Medicine.

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