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NEW YORK – The US Food and Drug Administration announced Tuesday that it has granted CLIA waiver to the Binx Health rapid point-of-care assay for detection of chlamydia and gonorrhea.

The assay, called the Binx Health io CT/NG Assay, runs on the io instrument and detects and distinguishes Chlamydia trachomatis and Neisseria gonorrhoeae in approximately 30 minutes using either female vaginal swab or male urine specimens.

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