Roche, Hologic, Cepheid nab separate FDA clearances for new STI tests

The FDA expanded the use of a handful of in vitro diagnostic tests aimed at sexually transmitted infections. (Andrew Harnik, Associated Press)

The FDA expanded the use of a handful of in vitro diagnostic tests aimed at sexually transmitted infections (STIs), including the first two to detect chlamydia and gonorrhea from specimens taken from outside the genital region.

“Prior to today, there were no chlamydia or gonorrhea tests cleared for use on samples from the throat and rectum,” Tim Stenzel, M.D., Ph.D., director of the in vitro diagnostics office of the FDA’s Center for Devices and Radiological Health, said in a statement. “The availability of these two tests will fill an unmet public health need, by allowing for more screening.”

They include Hologic’s Aptima Combo 2 Assay and Cepheid’s Xpert CT/NG test, which were previously only cleared for use on urine, vaginal and endocervical samples, the agency said.


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“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,” Stenzel added. “Today’s clearances provide a mechanism for more easily diagnosing these infections.”

According to a report from the Centers for Disease Control and Prevention, the rates of STIs have been increasing, with at least 1.7 million U.S. cases of chlamydia and more than 500,000 cases of gonorrhea in 2017.

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Additionally, Roche received an FDA green light for a new pair of STI tests on its automated cobas 6800/8800 system. The new test detects DNA related to Trichomonas vaginalis and Mycoplasma genitalium.

The parasite Trichomonas vaginalis causes trichomoniasis, or trich, the most common non-viral STI in the world, with about 70% of those infected not showing any symptoms. Infections related to the bacterium Mycoplasma genitalium are also largely asymptomatic but can cause inflammation and infertility.

When paired with Roche’s tests for chlamydia and gonorrhea, the cobas system can run four STI assays from a single patient sample, the company said, including from male and female urine as well as endocervical and vaginal swabs.

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