FDA Clears Tests for Chlamydia, Gonorrhea Using Extragenital Samples

The Food and Drug Administration (FDA) has cleared the Aptima Combo 2 Assay (Hologic) and the Xpert CT/NG (Cepheid) to detect chlamydia and gonorrhea via throat and rectum samples. Previously, these tests were approved for use with urine, vaginal, and endocervical samples.

The approval was based on data collected through a multisite study (N=2500) in which the diagnostic accuracy of nucleic acid amplification tests for detection of Neisseria gonorrhoeae and Chlamydia trachomatis from throat and rectal sites was evaluated. Results of the study showed that both the Aptima Combo 2 Assay and the Xpert CT/NG were safe and effective for extragenital testing.

“The availability of these two tests will fill an unmet public health need, by allowing for more screening,” said Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA.

For more information visit FDA.gov.