Visby Medical Receives Clearance from FDA and CLIA Waiver for PCR Sexual Health Test at the Point of Care

The Visby Medical Sexual Health Click Test is the first instrument-free polymerase chain reaction (PCR) test to detect Chlamydia, Gonorrhea, and Trichomonas that provides results within 30 minutes of the patient visit.

FREMONT, CA: Visby Medical™ confirms that the U.S. Food and Drug Administration (FDA) has granted it 510(k) clearance and a waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to market its rapid, single-use polymerase chain reaction (PCR) diagnostic test for the multiplexed detection of sexually transmitted infections (STIs) caused by Chlamydia trachomatis (C.T.). With the capacity to detect three of the most prevalent and treatable sexually transmitted infections (STIs), the Visby Medical Sexual Health Click Test is ideally positioned to meet the health requirements of women and promote positive health outcomes. As stated in the clinical trial results published in The Lancet Infectious Diseases, the test uses palm-sized PCR technology and produces accurate results in less than 30 minutes without extra tools.

The FDA-approved CLIA Waiver enables any healthcare setting given a CLIA Certificate of Waiver to administer the test during the patient's appointment, eliminating the need to send specimens to a laboratory and significantly shortening the time between initial testing and therapy. The Visby gadget can drastically lower rising STI rates, particularly in places with limited testing access.

“In the wake of the COVID-19 pandemic, there is an urgent need to address the rising rates of STIs in the U.S. 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,” says 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.”

According to a recent CDC analysis, females are disproportionately affected by STIs in adverse health outcomes and medical costs. Chlamydia and Gonorrhea are two of the most common causes of pelvic inflammatory disease (PID), resulting in infertility, ectopic pregnancy, and chronic pelvic pain. While Chlamydia and Gonorrhea infections must be reported to public health authorities, Trichomonas infections are not required to be reported—suggesting that trichomoniasis cases may be severely underreported. This is concerning since trichomoniasis raises one's risk of contracting HIV. Trichomonas infection in pregnant women can result in premature birth, pre-labor membrane rupture, and low birthweight kids.

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's Founder and CEO, Adam de la Zerda, Ph.D., an Associate Professor at Stanford University School of Medicine, believes that having an accurate test that can result in a single patient visit is vital for improving 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,” says Dr. 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.”