The FDA has granted 501k clearance for two tests that can detect the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae, which cause chlamydia and gonorrhea. The Aptima Combo 2 Assay (Hologic Inc.) and the Xpert CT/NG (Cepheid) are the first devices cleared for extragenital diagnostic testing of these infections via throat and rectum specimens.
The number of sexually transmitted infections in the U.S. is increasing, say the CDC: in 2017 alone, there were approximately 1.7 million cases of chlamydia and more than 500,000 cases of gonorrhea. Although both infections are easily treated, they can cause serious complications, including infertility, if left untreated.
The FDA reviewed clinical data from a cross-sectional study coordinated by the Antibacterial Resistance Leadership Group. The multisite clinical study of more than 2,500 patients evaluated the diagnostic accuracy of multiple nucleic-acid amplification tests for detecting Neisseria gonorrhoeae and Chlamydia trachomatis from throat and rectal sites. Study results demonstrated the safety and effectiveness of the Aptima Combo 2 Assay and Xpert CT/NG for extragenital testing for chlamydia and gonorrhea.
Source: FDA, May 23, 2019