FDA Clears the First Diagnostic Tests for Extragenital Testing for Chlamydia and Gonorrhea

May 24, 2019

On May 23, the U.S. Food and Drug Administration permitted marketing of two tests that can detect the presence of the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae, which cause sexually-transmitted infections.  The Aptima Combo 2 Assay and the Xpert CT/NG are the first devices cleared for diagnostic testing of these infections via the throat and rectum. These tests were previously only cleared for testing urine, vaginal and endocervical samples.  To read more about the new tests, see the FDA press release here