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FDA approves new tests for chlamydia and gonorrhoea

pharmafile | May 24, 2019 | News story | Medical Communications STIs, chlamydia, gonorrhoea, public health FDA 

The FDA has approved two new tests which make it easier to diagnose common STIs. The approval comes after a multi-site clinical study involving 2,500 patients.

The US regulator approved the Aptima Combo 2 Assay and  Xpert CT/NG diagnostic tests for detecting chlamydia and gonorrhoea using samples from the throat and rectum. Previous tests were only cleared for urine, vaginal and endocervical samples.

The director of the FDA Office of In Vitro Diagnostics and Radiological Health, 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.”

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According to figures from the CDC, there were 1.7 million cases of chlamydia and 500,000 cases of gonorrhoea in the United States in 2017 alone.

“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,” Stenzel added.

Louis Goss

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