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FDA Clears Cepheid, Hologic CT/NG Assays for Extragenital Testing

NEW YORK (GenomeWeb) – The US Food and Drug Administration announced today it has cleared tests from Cepheid and Hologic that detect chlamydia and gonorrhea for use with extragenital specimens, specifically from the throat and rectum.

These assays are the first to be cleared for extragenital indications for chlamydia and gonorrhea testing, the agency said in a statement.

The Hologic Aptima Combo 2 and the Cepheid Xpert CT/NG had previously only been cleared for testing of urine, vaginal, and endocervical samples.

"These two tests will fill an unmet public health need by allowing for more screening," said Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health.

The US Centers for Disease Control and Prevention estimates there were 1.7 million cases of chlamydia and more than 500,000 cases of gonorrhea in the US in 2017, and the number of cases is rising, as is drug-resistance.

Stenzel noted that significant complications can occur if infections are not caught and treated quickly, and that these cleared tests now "provide a mechanism for more easily diagnosing these infections."

The FDA reviewed clinical data collected through a multi-site study of more than 2,500 patients  in its evaluation of the devices. The study, which was coordinated by the Antibacterial Resistance Leadership Group, looked at the diagnostic accuracy of "multiple commercially available nucleic acid amplification tests for detection of Neisseria gonorrhoeae and Chlamydia trachomatis from throat and rectal sites," according to the statement.

The results of this study and 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 agency said.

Shares of Hologic were down a fraction of 1 percent at $44.75 in Thursday morning trade on the Nasdaq. Cepheid is a subsidiary of conglomerate Danaher.