The US Food and Drug Administration (FDA) on Thursday approved the marketing of two tests to detect the presence of the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae, which cause the sexually-transmitted infections, respectively, chlamydia and gonorrhea, through diagnostic testing of extragenital specimens.

The agency awarded the market clearance of Aptima Combo 2 Assay to Hologic Inc and the Xpert CT/NG to Cepheid.

According to the agency, the Aptima Combo 2 Assay and the Xpert CT/NG are the first devices cleared for extragenital diagnostic testing of these infections via the throat and rectum. These tests were previously cleared for testing urine, vaginal and endocervical samples. Both infections can be easily treated, but if left untreated, can cause serious complications for patients, including infertility.

Through the premarket notification (510(k)) pathway, the agency reviewed the clinical data collected in a cross-sectional study coordinated by the Antibacterial Resistance Leadership Group, which is funded and supported by the National Institute of Allergy and Infectious Diseases.

This collaborative, multi-site clinical study in 2,500 patients evaluated the diagnostic accuracy of multiple commercially available nucleic acid amplification tests for detection of Neisseria gonorrhoeae and Chlamydia trachomatis from throat and rectal sites. The results of this study, along with other information reviewed by the agency, 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.