First Devices for Extragenital Diagnostic Testing of Common STDs Get FDA Approval – Review Health World

The Cepheid Xpert CT / NG Test and the Hologic Aptima Combo 2 Assay have already been approved for testing endocervical, badl and urinary samples.

In its recent press release, the FDA announced that it was licensing the first devices that will be used for extrabad diagnostic tests for gonorrhea and chlamydia. Diagnostic testing of extrabad specimens using Xpert CT / NG and Aptima Combo 2 badays will help detect the possible presence of STD infections. Previously, both devices were allowed to test endocervical, badl and urinary samples. This time, they received the green signal for testing for STD infections through the rectum and throat. Cepheid, an American molecular diagnostic company, has obtained clearance from Xpert CT / NG and Hologic, a US medical device company, has obtained FDA clearance for the Aptima Combo 2 test.

"Before today, no screening test for gonorrhea or chlamydia had been allowed to use on samples taken in the rectum and throat. By allowing more screening, the availability of these two diagnostic tests will address an unmet public health need. For patients, it is preferable that these two STDs are detected and treated immediately, because if they are not treated, significant complications can occur. The authorizations that have taken place today make it easier to diagnose these infections, "said Tim Stenzel, MD, Ph.D., director of the FDA's Office for In Vitro Diagnostics and Radiology. (source).

The FDA has reviewed data collected as part of a multi-site collaborative clinical study

According to the FDA press release, the pre-market notification procedure (510 (k)) was used to review the Xpert CT / NG test and the Aptima Combo 2 baday. The clinical data collected as part of A cross-sectional study coordinated by a leadership group on antibacterial resistance was reviewed by the FDA during the evaluation of both diagnostic test devices. More than 2500 patients participated in the multi-site collaborative clinical study. The diagnostic accuracy of several commercially available nucleic acid amplification badays for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae in the rectum and throat was evaluated as part of the study.

According to the results of the study and the FDA's review of other information, the Xpert CT / NG and Aptima Combo 2 tests used for extrabad specimens are effective and safe for extrabad testing of gonorrhea and chlamydia.