FDA approves first POCT for chlamydia and gonorrhea

March 31, 2021

The U.S. Food and Drug Administration (FDA) announced it is allowing the use of the Binx Health IO CT/NG Assay at point-of-care settings, according to a news release from the agency.

The types of setting include physician offices, community-based clinics, urgent care settings, and outpatient healthcare facilities.

“More convenient testing with quicker results can help patients get access to the most appropriate treatment. According to the CDC (Centers for Disease Control and Prevention), one in five Americans are diagnosed with sexually transmitted infections every year, which is why access to faster diagnostic results and faster, more appropriate treatments will make significant strides in combatting these infections,” 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.

The test, which uses female vaginal swabs and male urine specimens, can detect the presence of the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae, which cause the sexually transmitted infections chlamydia and gonorrhea, respectively. The test provides results in about 30 minutes.

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