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Home  /  FDA   /  binx health Receives FDA 510(k) Clearance For Rapid Point Of Care Platform For Women’s Health

binx health Receives FDA 510(k) Clearance For Rapid Point Of Care Platform For Women’s Health

Binx Health, the pioneer in anywhere, anytime testing for women’s health, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its first-of-kind, highly sensitive and specific, molecular point-of-care (POC) diagnostic testing platform, the binx io®.  The binx io platform is a rapid, qualitative, fully-automated test, designed to be easy to use, and intended for use in POC or clinical laboratory settings, providing the world’s first sample-to-answer result in about 30 minutes for the detection of chlamydia (CT) and gonorrhea (NG)—the two most tested-for STIs globally. In the Company’s recently completed 1,523-person, multi-center clinical study, 96% of patient samples were processed on the binx io by non-laboratorians in a POC setting.

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