FDA authorizes marketing of new test to aid in the diagnosis of M. gen. infections

The U.S. Food and Drug Administration today permitted marketing of a new test to aid in the diagnosis of a sexually-transmitted infection (STI) called Mycoplasma genitalium (M. gen.). This is the first test authorized by the FDA to test for the M. gen. bacterium, which is associated with inflammation of the urethra (non-gonococcal urethritis) in men and inflammation of the cervix (cervicitis) and infection of the reproductive organs (pelvic inflammatory disease) in women.

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

According to the U.S. Centers for Disease Control and Prevention, M. gen. is responsible for causing approximately 15 to 30 percent of persistent or recurrent urethritis cases in men in the United States and 10 to 30 percent of cervicitis cases in women. M. gen. is a slow-growing bacterium and is difficult to detect with traditional laboratory methods. The Aptima Mycoplasma genitalium Assay, granted marketing authorization by the FDA today, is a nucleic acid amplification test, which detects M. gen. in urine, urethral, penile meatal, endocervical or vaginal swab samples collected in a clinical setting, such as a doctor's office or clinic.

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 M. gen. in approximately 90 percent of vaginal, male urethral, male urine and penile samples. It correctly identified M. gen. in female urine and endocervical samples 77.8 percent of the time and 81.5 percent of the time, respectively. Vaginal swabs are the preferred sample type due to better clinical performance, however, alternative sample types, such as urine, can be used if vaginal swabs are not available. In addition, the study showed that the test correctly identified samples that did not have M. gen. present 97.8 to 99.6 percent of the time.

The FDA reviewed the Aptima Mycoplasma genitalium Assay through the De Novo premarket pathway, a regulatory pathway for low-to-moderate-risk devices of a new type. Through the De Novo authorization, the FDA is establishing special controls for tests of this type, including requirements for demonstrating the accuracy and reliability of tests intended to be used as an aid in the diagnosis of M. gen. urogenital infections. The special controls, when met along with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type.

This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA's 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.

The FDA granted marketing authorization of the Aptima Mycoplasma genitalium Assay to Hologic Inc.

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