FDA Clears First Diagnostic Test for Mycoplasma genitalium

Megan Brooks


January 24, 2019

The US Food and Drug Administration (FDA) has approved the Aptima Mycoplasma genitalium Assay from Hologic Inc, the first and only FDA-approved test to aid in the diagnosis of this sexually transmitted infection.

M genitalium is a common cause of nongonococcal urethritis in men and cervicitis and pelvic inflammatory disease in women. These slow-growing bacteria are difficult to detect with traditional laboratory methods.

"Patients with unidentified urogenital infections are typically treated with antibiotics, some of which may not be effective against M gen," FDA Commissioner Scott Gottlieb, MD, said in a news release.

"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. In cases where M gen is detected, doctors can consider forgoing use of antibiotics that are known to be ineffective against M gen and choose a treatment more likely to be appropriate," said Gottlieb.

The Aptima nucleic acid amplification test detects M genitalium in urine, urethral, penile meatal, endocervical, or vaginal swab samples collected in a physician's office or clinic.

In testing of 11,774 clinical samples, the assay correctly identified the M genitalium in roughly 90% of vaginal, male urethral, male urine, and penile samples. Accuracy was 77.8% in female urine samples and 81.5% in endocervical samples.

The FDA said vaginal swabs are the preferred sample type, owing to better clinical performance; however, alternative sample types, such as urine, can be used if vaginal swabs are not available.

In addition, the Aptima assay correctly identified samples that did not have M genitalium 97.8% to 99.6% of the time.

Tom West, president of diagnostic solutions at Hologic, said the assay is "immediately available to clinical laboratory customers. Our sales and technical support teams are ready to help labs around the country to bring this new molecular diagnostic test on board. To continue to further Hologic's mission of caring for patients, we directly offer medical education to labs and ordering physicians to enable them to implement the test into their services and ordering practice as quickly as possible. If a physician is interested in ordering this test, he or she should reach out to their clinical laboratory partner."

Hologic anticipates that most insurance plans will cover the Aptima Mycoplasma genitalium Assay.

The Aptima Mycoplasma genitalium Assay was reviewed through the de novo premarket pathway, a regulatory pathway for some low- to moderate-risk devices of a new type. Along with this marketing authorization, the FDA is establishing "special controls" designed to provide a "reasonable assurance of safety and effectiveness for tests of this type," the agency said.

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