FDA Clears Extragenital Tests for Chlamydia and Gonorrhea

The US Food and Drug Administration (FDA) has approved marketing for 2 tests that can detect bacteria that cause chlamydia and gonorrhea through diagnostic testing of extragenital specimen. The 2 tests, Aptima Combo 2 Assay and Xpert CT/NG are the first devices cleared for testing for these sexually transmitted infections (STIs) via the throat and rectum.

The US Centers for Disease Control and Prevention (CDC) estimates that the rate of STIs are on the rise with an estimated 1.7 million cases of chlamydia and more than 500,000 cases of gonorrhea documented in 2017 in the United States. Both STIs can be contracted through vaginal, anal, or oral intercourse. The infections are typically easily treated, but, if left untreated, can result in serious complications including infertility.

Both the Aptima Combo 2 Assay and Xpert CT/NG were previously cleared by the FDA for testing urine, vaginal, and endocervical samples.

The tests were reviewed through the premarket notification 510(k) pathway, which is a submission made to the FDA demonstrating that the device is safe and effective and “substantially equivalent” to a legally marketed device.

The FDA’s decision was based on a review of clinical data from a cross-sectional study of more than 2500 patients that evaluated accuracy of multiple commercially available nucleic acid amplification tests for the bacteria Neisseria gonorrhoeae and Chlamydia trachomatis from the throat and rectum. The study, which was coordinated by the Antibacterial Resistance Leadership Group, and funded and supported by the National Institute of Allergy and Infectious Diseases, demonstrated that both tests for extragenital specimens are safe and effective in testing for these STIs.

"Prior to today, there were no chlamydia or gonorrhea tests cleared for use on samples from the throat and rectum. 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 in the FDA's Center for Devices and Radiological Health, in a statement. "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. Today's clearances provide a mechanism for more easily diagnosing these infections."

The clearance of Aptima Combo 2 Assay and Xpert CT/NG were granted to Hologic, Inc and Cepheid, respectively.