FDA Grants Marketing to STI Assay

The US Food and Drug Administration (FDA) has permitted the marketing of a new test designed to aid in the diagnosis of Mycoplasma genitalium (M. gen), a sexually-transmitted infection (STI) prevalent in cases of continued male urethritis.

The Aptima Mycoplasma genitalium Assay, from Hologic Inc., was granted marketing approval upon the FDA’s review of clinical trial data showing its accuracy in 11,774 samples. In the trial, the assay correctly identified M. gen in approximately 90% of all vaginal, male urethral, male urine, and penile samples. In female urine it correctly identified the disease 77.8% of the time, and in endocervical samples, 81.5% of the time.

With its approval, the FDA noted that vaginal swabs are commonly the preferred sample type for M. gen testing due to their better clinical performance, but alternative sample types such as urine are acceptable. The assay was also able to correctly identify samples without the infection present in 97.8% to 99.6% of cases.

The assay was assessed by the FDA through the De Novo premarket pathway, a regulatory pathway for low-to-moderate-risk devices of a new type.

M. gen is responsible for about 15% to 30% of all persistent or recurrent urethritis cases in US men, and 10% to 30% of cervicitis cases in women. As a slow-growing, difficult-to-detect bacterium, M. gen may not even be affected by the commonly-prescribed antibiotics. FDA commissioner Scott Gottlieb, MD, explained it is just difficult to diagnose the M. gen 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,” Gottlieb said in a statement. “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.”

Gottlieb explained that an accurate, reliable assay can aid physicians in providing the right therapy in the right situation, reducing the overuse of antibiotics and the burden of care in fighting antimicrobial resistance.