For immediate release:
May 23, 2019

Today, the US Food and Drug Administration has authorized the marketing of two tests capable of detecting the presence of Chlamydia trachomatis and Neisseria gonorrhoeae, which are responsible for sexually transmitted infections, chlamydia and gonorrhea, respectively, using diagnosis of extragenital specimens. The Aptima Combo 2 Assay and the Xpert CT / NG Assay are the first validated instruments for extragenital diagnostic testing of these throat and rectal infections. Previously, these tests were only allowed for urine, vaginal and endocervical samples.

"Before today, no screening test for chlamydia or gonorrhea was allowed for use on samples taken in the throat and rectum. The availability of these two tests will address an unmet need for public health, allowing more screenings, "said Tim Stenzel, MD, Ph.D., director of the Office of In Vitro Diagnostics and Radiation Health at FDA Device and Device Center. Radiological health. "It is best for patients that these two sexually transmitted infections are immediately detected and treated, as significant complications can occur if they are not treated. Current authorizations provide a mechanism to diagnose these infections more easily. "

According to the Sexually Transmitted Infections Surveillance Report by the Centers for Disease Control and Prevention, the rate of sexually transmitted infections is steadily increasing, with approximately 1.7 million cases of chlamydia and over 500,000 cases of gonorrhea in the United States. United States in 2017 only. Both infections can be contracted during vaginal, anal or oral sex. As a rule, both infections can be easily treated, but if they are not treated, both infections can lead to serious complications for patients, including infertility.

The Aptima Combo 2 and Xpert CT / NG tests were examined via the pre-marketing notification procedure (510 (k)). A 510 (k) is a pre-market submission to the FDA to demonstrate that the device to be commercialized is at least as safe and effective as it is virtually equivalent to a device marketed legally.

In its evaluation of the devices, the FDA reviewed the clinical data collected as part of a cross-sectional study coordinated by the Bacterial Resistance Group, funded and supported by the National Institute of Allergy and Infectious Diseases. This was a multi-site collaborative clinical study involving more than 2,500 patients that evaluated the diagnostic accuracy of multiple commercially available nucleic acid amplification assays for Neisseria gonorrhoeae and Chlamydia detection. trachomatis at the sites of the throat and rectum. 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 Extra-genital Specimen Test are safe and effective for extragenital testing for chlamydia. and gonorrhea.

The FDA has authorized the approval of the Aptima Combo 2 test at Hologic, Inc.

The FDA has authorized Xpert CT / NG to Cepheid.

The FDA, an agency of the US Department of Health and Social Services, protects public health by ensuring the safety, efficacy and safety of human and veterinary drugs, vaccines and other biological products for human use and medical devices. The agency is also responsible for the safety of food products, cosmetics, food supplements, products emitting electronic radiation and the regulation of tobacco products.

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