Medline today announced a new partnership with Visby Medical (Visby), an award-winning medical diagnostic company, for distribution of Visby Medical’s Sexual Health Click Test, a groundbreaking Clinical Laboratory Improvement Amendments (CLIA) waived, PCR diagnostic test for sexually transmitted infections (STIs) for women that fits in the palm of your hand.
As STIs are at an all-time high for the sixth consecutive year in the U.S., Medline will bring this new Food and Drug Administration (FDA)-cleared technology to healthcare organizations in all 50 states and across the continuum of care, including urgent care centers, student health centers, women’s health facilities, and community health centers.
The Visby PCR point-of-care device is an all-in-one unit that requires no separate instrument or reader. Designed to provide accurate diagnosis in under 30 minutes, the Visby device enables clinicians to discuss results and prescribe personalized treatment during the patient visit – rather than days later – eliminating the need for presumptive treatment.
“Our partnership with Visby demonstrates our commitment to bringing leading-edge medical innovations to the point of care that revolutionize patient care,” said Doug Sharpe, vice president of Lab Capital at Medline. “Winning several awards for design innovation and excellence, the Visby device is the first PCR test of its kind and gives clinicians a tool to help improve patient outcomes.”
According to a recent study in The Lancet Infectious Diseases, the Visby Medical Sexual Health Click Test is potentially the new gold standard for point-of-care tests for infectious diseases such as STIs in which rapid turnaround is key. As a finalist for the 2022 AACC Disruptive Technology Award, the Visby device has ~97% accuracy or greater for the detection of chlamydia, gonorrhea, and trichomonas, the three most common pathogens that can foster contagion and permanently damage a woman’s reproductive system if left untreated.
“Visby’s development of the world’s first instrument-free handheld PCR platform to accurately and rapidly test for a variety of serious infections is changing how healthcare is delivered, especially in urgent care and women’s health settings,” said Visby Medical Founder and CEO Adam de la Zerda. “Our partnership with Medline will help our innovative testing technology reach clinicians quickly, helping us improve STI containment, prevention, and treatment.”