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FDA Clearance and CLIA Waiver at the Point of Care for PCR Sexual Health Test

The Visby Medical Sexual Health Click Test is the first instrument-free PCR test for the detection of certain STIs

Sep 15, 2021
Visby Medical

SAN JOSE, CA — Visby Medical™ announced today that it has received a 510(k) clearance and was granted a waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) from the U.S. Food and Drug Administration (FDA) to market its fast, single-use polymerase chain reaction (PCR) diagnostic test for the multiplexed detection of sexually transmitted infections (STIs) caused by Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV), using a self-collected vaginal swab.

With the capability to detect three of the most common and treatable STIs, the Visby Medical Sexual Health Click Test is uniquely positioned to address women's health needs and promote positive health outcomes. As described in the clinical trial results published by The Lancet Infectious Diseases, the test offers PCR technology in palm-sized dimensions and provides accurate results in under 30 minutes, with no additional instruments required.

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 Visby device could significantly reduce growing STI rates, especially in communities with limited access to testing. 

"In the wake of the COVID-19 pandemic, there is an urgent need to address the rising rates of STIs in the US. Without an accurate test result, we are fighting blind, often prescribing STI treatments before we have a clear diagnosis, which can lead to delayed or ineffective treatment and to the emergence of antibiotic-resistant microbes," said Gary Schoolnik, MD, an infectious disease expert, chief medical officer at Visby Medical, and professor of medicine at Stanford University. "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." 

A recent report by the CDC highlighted that females are disproportionately burdened by STIs, both in terms of negative health outcomes and medical costs. Chlamydia and Gonorrhea are major causes of pelvic inflammatory disease (PID), which can lead to infertility, ectopic pregnancy, and chronic pelvic pain. While Chlamydia and Gonorrhea infections must be reported to public health authorities, no such requirement exists for Trichomonas infections—meaning that cases of trichomoniasis might be significantly underreported. This causes concern because trichomoniasis increases the risk of HIV infection. With pregnant women, Trichomonas can result in preterm birth, pre-labor rupture of membranes, and low birthweight babies.

According to clinical professor of medicine, population and public health sciences, Jeffrey D. Klausner, MD, MPH, University of Southern California, "For both patient care and public health control of these STIs, the Visby Medical Sexual Health Click Test represents a breakthrough. We will now have exact test results to treat women correctly, avoiding unnecessary over-treatment, and greatly reducing the time to treatment, which will reduce transmission and complications." 

Visby Medical Founder and CEO, Adam de la Zerda, PhD, who is also associate professor at Stanford University School of Medicine, firmly believes it is critically important to have an accurate test that can return results in a single patient visit to foster better patient outcomes. 

"This FDA clearance and CLIA Waiver further validate our technology and allows us to start changing how infectious diseases are identified and treated to improve patient lives and public health monitoring," said de la Zerda. "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." 

- This press release was originally published on the Visby Medical website