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Visby Medical™ Receives FDA Clearance and CLIA Waiver for Second Generation Sexual Health Test for Women

Wednesday, March 15, 2023

Visby Medical™ announced today that it has received 510(k) clearance and was granted a CLIA waiver from the U.S. Food and Drug Administration for its second generation point of care (POC) test. The Visby Medical Sexual Health test is a fast, polymerase chain reaction (PCR) diagnostic test for the detection of sexually transmitted infections (STIs) caused by Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis in women.

Visby Medical created the first and only "instrument-free" platform that offers true PCR technology in the palm of your hand.  The CLIA-waived, Sexual Health POC test provides accurate results in under 30 minutes, enabling clinicians to test, talk and accurately treat with confidence in a single patient visit. The new, sleeker design of the test transforms an already easy-to-use device by turning four actions into one while maintaining about 97 percent accuracy. This new device delivers significant improvements in workflow, manufacturability, and reliability compared to its predecessor.

"We are excited that the clearance of the second generation Sexual Health Test will enable us to move production to our fully automated lines, allowing us to deliver more tests to eagerly waiting customers," said Visby Medical Senior Vice President of Operations, Mark Medlen. There is a significant unmet need to improve accuracy and time-to-diagnosis in STI testing, which often takes two to five days or more to return results. In April 2022, the Centers for Disease Control and Prevention reported that STIs have reached an all-time high for the sixth consecutive year, with a nearly 30% increase in gonorrhea and chlamydia between 2015 and 2019.

According to Gary Schoolnik, MD, an infectious disease expert, Chief Medical Officer at Visby Medical, and Professor of Medicine at Stanford University, "Providing more customers with access to the Visby platform will enable clinicians to make informed treatment decisions during the span of a single clinic visit. This will help reduce overtreatment and undertreatment rates, as well as the number of patients who are lost to care.  By providing a prompt and accurate test result, the use of this test will lower the likelihood that an infected patient will develop pelvic inflammatory disease. It will expedite the treatment of that patient's sexual partner, and it will reduce the spread of sexually transmitted infections overall."

"The Visby Sexual Health Test has been a game changer for us. My patients come in, self-collect and get answers in the same visit. I appreciate that it facilitates education; I can provide specific education and this really helps reduce patient anxiety. It's a better patient experience. We've simplified our workflow with reduced need to chase down patients for results and pharmacy preferences. I'm also spending less time reviewing lab results in my inbox too. All this has really led to a lot of satisfaction in our office." said Dr. Denise Sweeney of Associates in Women's Healthcare of Roseville, CA.

"Visby innovation has become essential for maintaining quality urgent care and positive patient experience in our practice," said Lamont Tyler, MD, Market Medical Director of CareNow Urgent Care Henderson, Nevada. "Fast and accurate results mean we can usually keep our 'door to discharge time' under one hour -- patients have a convenient, complete engagement, and we are able to provide appropriate care without the risk of unnecessary antibiotics that can happen when a definitive diagnosis is delayed. The Visby test is a win-win, helping fight antibiotic resistance as well as the spread of untreated infection, while empowering patients to engage health services with greater confidence."



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