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LetsGetChecked Nabs FDA Marketing Authorization for Chlamydia, Gonorrhea Test

NEW YORK – The US Food and Drug Administration announced on Wednesday that it has granted de novo marketing authorization to LetsGetChecked for its Simple 2 test for chlamydia and gonorrhea.

According to the agency, this is the first diagnostic test for chlamydia and gonorrhea with at-home sample collection to receive marketing authorization — previous tests were only cleared for samples collected at the point of care. It is also the first FDA-authorized test with at-home sample collection for any sexually transmitted disease other than HIV, the FDA noted.

The assay is available over the counter and is intended for use in adult patients ages 18 and older, the agency said. It uses vaginal swabs or urine specimens, collected at home and sent back to a designated laboratory, to detect the presence of Chlamydia trachomatis and Neisseria gonorrhoeae. The test includes the Simple 2 Home Collection Kits that were validated for use with Hologic's Aptima Combo 2 Assay, the FDA said.

"This authorization marks an important public health milestone, giving patients more information about their health from the privacy of their own home," Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement. "We are eager to continue supporting greater consumer access to diagnostic tests, which helps further our goal of bringing more healthcare into the home."

As a result of the de novo authorization, a new regulatory classification has been created, and subsequent devices of the same type with the same intended use will be able to go through the FDA's 510(k) premarket clearance process, the agency said.