Shots:

• The approval follows the clinical study assessing Hologic’s Aptima Combo 2 Assay and Cepheid’s Xpert CT/NG in 2-500+ patients to detect the presence of the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae through diagnostic testing of extragenital specimens
• The study results demonstrated that Aptima Combo 2 Assay and the Xpert CT/NG for extragenital specimens are safe and effective for extragenital testing in chlamydia and gonorrhea via throat and rectum
• The Aptima Combo 2 Assay & Xpert CT/NG is a nucleic acid probe test & in vitro real-time PCR test used for qualitative detection and differentiation of rRNA & genomic DNA to diagnose CT & GC using Tigris DTS System/Panther system & GeneXpert Instrument Systems respectively

Ref: US FDA | Image: ResearchGate- Clinical Laboratory