FDA clears 1st extragenital STD tests

2019 05 24 21 56 3410 Gonorrhea Neisseria Gonorrhoeae 400

The U.S. Food and Drug Administration (FDA) has cleared the first diagnostic tests designed to detect the presence of the bacteria that cause chlamydia and gonorrhea using samples collected outside the genitals.

The tests are designed to detect the presence of the bacteria Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) with extragenital specimens acquired via the throat and rectum. Previously, the tests were cleared only for use with urine, vaginal, and endocervical samples.

The clearances are for the Aptima Combo 2 assay from Hologic and the Xpert CT/NG test from Cepheid.

In clearing the tests, the FDA reviewed clinical data acquired through a cross-sectional study that was coordinated by the Antibacterial Resistance Leadership Group, a multisite study of 2,500 patients that evaluated the diagnostic accuracy of commercially available nuclear acid amplification tests for detecting Neisseria gonorrhoeae and Chlamydia trachomatis with samples acquired from throat and rectal sites.

The FDA's clearance of the tests will expand the range of options available for detecting chlamydia and gonorrhea and will allow for more screening, according to the agency. There were an estimated 1.7 million cases of chlamydia and over 500,000 cases of gonorrhea in the U.S. in 2017, according to the FDA.

Page 1 of 1