June 5, 2019—Two diagnostic tests for extragenital testing for chlamydia and gonorrhea have received 510(k) clearance by the U.S. Food and Drug Administration. The Aptima Combo 2 Assay (Hologic) and the Xpert CT/NG (Cepheid) are the first devices cleared for detecting the presence of Chlamydia trachomatis and Neisseria gonorrhoeae via the throat and rectum. These tests were previously cleared only for testing urine, vaginal, and endocervical samples.
“The availability of these two tests will fill an unmet public health need, by allowing for more screening,” 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, said in a press release. “It is best for patients if both of these sexually transmitted infections are caught and treated right away, as significant complications can occur if left untreated.”
In its evaluation of the devices, the FDA reviewed clinical data collected through a cross-sectional study coordinated by the Antibacterial Resistance Leadership Group. The study was a collaborative, multisite clinical study of more than 2,500 patients that evaluated the diagnostic accuracy of multiple commercially available nucleic acid amplification tests for detection of Neisseria gonorrhoeae and Chlamydia trachomatis from throat and rectal sites. The results of this study, along with other information reviewed by the FDA, demonstrated that the Aptima Combo 2 Assay and the Xpert CT/NG for extragenital specimens are safe and effective for extragenital testing for chlamydia and gonorrhea.