08/30/2021
•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.
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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:- Lancet Infect Dis 2021;21: 668–76
- 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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