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Medical Devices / Submissions and Approvals

FDA Clears Hologic’s Assay for Sexually Transmitted Infection

Jan. 25, 2019

The FDA granted marketing clearance to Hologic’s Aptima diagnostic test for Mycoplasma genitalium, an increasingly common sexually transmitted infection. The agency reviewed the test through the De Novo premarket pathway for low-to-moderate-risk devices of a new type.

Aptima is the first test authorized by the FDA to test for the bacterium, which is associated with inflammation of the urethra in men and inflammation of the cervix and infection of the reproductive organs in women.

“In the past, it has been hard to diagnose this organism. By being able to detect it more reliably, doctors may be able to more carefully tailor treatment and use medicines most likely to be effective,” FDA Commissioner Scott Gottlieb said.

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