FDA Clears 30-Minute Chlamydia, Gonorrhea Test

The US Food and Drug Administration (FDA) has cleared the Binx Health IO CT/NG Assay, a test that detects Chlamydia trachomatis and Neisseria gonorrhoeae in roughly 30 minutes, for use in point-of-care settings.

The test was previously cleared for use by individuals trained in the test procedure under the oversight of a CLIA certified laboratory. The current waiver granted by the FDA expands its approved use to point-of-care settings.

It uses vaginal swabs and male urine specimens to detect the bacteria, is performed while the patient is present, and supplies results in about 30 minutes. The effectiveness of the test was demonstrated in female patients aged 16 years and older and male patients aged 17 years and older.

“The ability to diagnose at a point-of-care setting will help with more quickly and appropriately treating sexually-transmitted infections, which is a major milestone in helping patients,” said Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, in a press release from the FDA.

—Michael Potts

Reference:

FDA allows for first point-of-care chlamydia and gonorrhea test to be used in more near-patient care settings. News release. March 30, 2021. https://www.fda.gov/news-events/press-announcements/fda-allows-first-point-care-chlamydia-and-gonorrhea-test-be-used-more-near-patient-care-settings