FDA Clears Assays for Extragenital Chlamydia/Gonorrhea Testing

Megan Brooks


May 23, 2019

The US Food and Drug Administration (FDA) has cleared two tests to detect Chlamydia trachomatis and Neisseria gonorrhoeae from throat and rectum samples.

The Aptima Combo 2 Assay (Hologic Inc) and the Xpert CT/NG (Cepheid) are the first tests approved for extragenital diagnostic testing for these infections via throat and rectum samples. These tests were previously approved only for testing urine, vaginal, and endocervical samples.

Until now, there were no chlamydia or gonorrhea tests that were approved for use with samples from the throat and rectum, 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, noted in a news release.

"The availability of these two tests will fill an unmet public health need, by allowing for more screening," he said, and "provide a mechanism for more easily diagnosing these infections."

The rate of sexually transmitted infections is steadily increasing. There were an estimated 1.7 million cases of Chlamydia infection and more than 500,000 cases of gonorrhea in the United States in 2017, according to the Centers for Disease Control and Prevention.

In evaluating the Aptima Combo 2 Assay and Xpert CT/NG, the FDA reviewed clinical data from a cross-sectional study coordinated by the Antibacterial Resistance Leadership Group, which is funded and supported by the National Institute of Allergy and Infectious Diseases.

The study, which included more than 2500 patients, 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," the FDA said.

Both tests were reviewed through the premarket notification 510(k) pathway, which means that the manufacturers demonstrated that the devices are "substantially equivalent" to legally marketed devices.

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