Hologic and Cepheid have secured approval from the US Food and Drug Administration (FDA) for diagnostic tests for extragenital testing for chlamydia and gonorrhea.
Image: The US FDA’s Center for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration.
The FDA has approved two tests, which can detect the presence of the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae that cause sexually-transmitted infections called chlamydia and gonorrhea.
Hologic’s Aptima Combo 2 assay and Cepheid’s Xpert CT/NG are claimed to be the first devices secured approval for extragenital diagnostic testing of these infections through the throat and rectum.
Earlier, the company secured approval for these tests to test urine, vaginal and endocervical samples.
As per the Centers for Disease Control and Prevention’s Sexually Transmitted Infections Surveillance Report, the rate of sexually transmitted infections is steadily increasing, with an estimated 1.7 million cases of chlamydia and more than 500,000 cases of gonorrhea in the U.S. in 2017 alone
In its assessments of the devices, the FDA evaluated clinical data collected via cross-sectional study coordinated by the Antibacterial Resistance Leadership Group, which is funded and supported by the National Institute of Allergy and Infectious Diseases.
The multi-site clinical study, which recruited more than 2,500 patients, has assessed the diagnostic accuracy of multiple commercially available nucleic acid amplification tests to detect Neisseria gonorrhoeae and Chlamydia trachomatis from throat and rectal sites.
The results of this study, along with other information assessed by the FDA, showed 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, said FDA.
FDA’s Center for Devices and Radiological Health in vitro diagnostics and radiological health office director Dr Tim Stenzel said: “Prior to today, there were no chlamydia or gonorrhea tests cleared for use on samples from the throat and rectum. The availability of these two tests will fill an unmet public health need, by allowing for more screening.
“It is best for patients if both of these sexually transmitted infections are caught and treated right away, as significant complications can occur if left untreated. Today’s clearances provide a mechanism for more easily diagnosing these infections.”