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

08/30/2021Press Release

Visby Medical™ Receives 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 Chlamydia, Gonorrhea, and Trichomonas, with results available within 30 minutes, during the patient visit.

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

San Jose, CA – August 30, 2021 – 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 US 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.1

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 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,” 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.2 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 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.”

About Visby Medical™

Visby Medical has been working to change the order of diagnosis and treatment of infectious diseases for a decade. Visby Medical has a single-use PCR platform to rapidly test for serious infections, originally developed for sexually transmitted infections. Tested, reviewed, and endorsed by top public and private organizations, the first commercial application of the Visby Medical technology received FDA Emergency Use Authorization in 2020 for moderate-complexity laboratory testing of symptomatic patients in the fight against COVID-19, and in 2021 for use in settings with a CLIA Certificate of Waiver. Visby Medical is partnering with government and private entities to accelerate the delivery of PCR-grade diagnostics, designed for use at the point of care, and eventually for use at home.

Contact: The Visby Medical Press Team press@visbymedical.com

Citations:

  1. Lancet Infect Dis 2021;21: 668–76
  2. Sexually Transmitted Infections Among US Women and Men: Prevalence and Incidence Estimates, 2018, Sexually Transmitted Diseases: April 2021 – Volume 48 – Issue 4 – p 208-214 doi: 10.1097/OLQ.0000000000001355

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