Hologic & Cepheid’s Diagnostic Tests Receive 510(k) Clearance for Extragenital Testing in Chlamydia and Gonorrhea

Hologic & Cepheid’s Diagnostic Tests Receive 510(k) Clearance for Extragenital Testing in Chlamydia and Gonorrhea

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

Click here to read full press release/ article | Ref: US FDA | Image: ResearchGate, Clinical Laboratory