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 granted marketing authorization of the Aptima Mycoplasma genitalium Assay to Hologic Inc.
- Malaysia health officials battle anti-vaccine propaganda
- Enterobacter cloacae infections linked to unapproved stem cell injections in LA County
- Measles outbreak in South Korea
- Prion infection: New skin test detects infection prior to symptoms
- Measles outbreak rises to 23 in Clark County
- Dengue Immunity May Be Protective Against Symptomatic Zika, Study Finds