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Hologic M. Genitalium Assay Gets FDA De Novo Clearance

NEW YORK (GenomeWeb) – The US Food and Drug Administration today granted de novo clearance that permits marketing of Hologic's Aptima assay for Mycoplasma genitalium sexually-transmitted infection in men and women.

The FDA said that this is the first test it has authorized to test for M. genitalium, a slow-growing bacterium that is difficult to detect with traditional laboratory methods and is associated with inflammation of the urethra in men and inflammation of the cervix and infection of the reproductive organs in women.

Hologic's Aptima assay is an in vitro nucleic acid amplification test used for the qualitative detection of M. genitalium rRNA on the firm's fully automated Panther system. It detects M. genitalium in urine, urethral, penile-meatal, endocervical, or vaginal swab samples collected in a clinical setting, such as a doctor's office or clinic.

"Patients with unidentified urogenital infections are typically treated with antibiotics, some of which may not be effective against [M. genitalium]," FDA Commissioner Scott Gottlieb said in a statement. "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. genitalium is detected, doctors can consider forgoing use of antibiotics that are known to be ineffective against it and choose a treatment more likely to be appropriate, Gottlieb said.

"Having accurate and reliable tests to identify the specific bacteria that's causing an infection can assist doctors in choosing the right treatment for the right infection, which can reduce overuse of antibiotics and help in the fight against antimicrobial resistance," he added.

Citing the US Centers for Disease Control and Prevention, the FDA noted that M. genitalium is responsible for about 15 to 30 percent of persistent or recurrent urethritis cases in men living in the US and 10 to 30 percent of cervicitis cases in women living in the US.

In deciding on the clearance through the de novo premarket regulatory pathway for low-to-moderate-risk devices of a new type, the FDA reviewed data from a clinical study that included testing of 11,774 samples. The study showed that the Aptima Mycoplasma genitalium assay correctly identified the bacteria in about 90 percent of vaginal, male urethral, male urine, and penile samples. It correctly identified the bacteria in female urine and endocervical samples 77.8 percent of the time and 81.5 percent of the time, respectively.

Further, the study showed that the test correctly identified samples that did not have M. genitalium 97.8 to 99.6 percent of the time.

In anticipation of potential de novo clearance of an M. genitalium assay, SpeeDx commenced clinical trials on its own test in May last year.