Is it true the FDA authorized the first STD testing for point of care settings to be used for more near-patient care settings?


Yes, this spring, the U.S. Food and Drug Administration (FDA) granted authorization for the utilization of the Binx Health IO CT/NG Assay at point-of-care settings to aid in the detection and diagnosis of two sexually transmitted diseases, chlamydia, and gonorrhea. More specifically, these settings encompass physician offices, community-based clinics, urgent care settings, outpatient health care facilities, and other patient care settings, operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. The outcome occurred because the FDA allowed for a waiver under the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) for the Binx Health IO CT/NG Assay.

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