FDA Approves Test for Mycoplasma genitalium Detection

The Food and Drug Administration (FDA) has granted permission to Hologic Inc. to market the Aptima Mycoplasma genitalium Assay, a test to detect Mycoplasma genitalium (M. genitalium), a sexually-transmitted infection (STI).

The test is the first authorized for M. genitalium bacterium detection, which is generally hard to diagnose. “By being able to detect it [M. gen.] more reliably, doctors may be able to more carefully tailor treatment and use medicines most likely to be effective,” said FDA Commissioner Scott Gottlieb, MD.

The Aptima assay is a nucleic acid amplification test designed for use in a clinical setting. The approval was based on a clinical study that included 11,774 samples which showed that the Assay correctly identified the infection in ~90% of vaginal, male urethral, male urine and penile samples; in female urine and endocervical samples, the accuracy was 77.8% and 81.5%, respectively. 

“Although Mycoplasma genitalium is typically more common than gonorrhea, there is very little public awareness of this rising sexually transmitted infection, which can cause serious and potentially devastating health problems,” said Damon Getman, PhD, senior principal research scientist and director of research at Hologic.

In the US, M. genitalium is responsible for causing ~15 to 30% of urethritis cases in men and ~10 to 30% of cervicitis case in women.  A study involving patients with M. genitalium showed a high rate of macrolide antibiotic resistance, with 50.8% of females and 42% of males having an antibiotic-resistant strain.