FDA Grants CLIA Waiver Allowing First Test for Chlamydia and Gonorrhea to Be Performed at the Point of Care

Federal regulators continue to recognize value of clinical laboratory testing in near-patient settings To help in the diagnosis and management of two sexually-transmitted diseases, another point-of-care diagnostic test will soon be available for use in physician’s offices, urgent care clinics, and other healthcare settings. The federal Food and Drug Administration (FDA) announced it granted a CLIA waiver for the binx health io CT/NG assay, a molecular platform used to detect sexually...
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