The US FDA has permitted marketing of a new test from Hologic to aid in the diagnosis of the sexually transmitted infection (STI) 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. As a slow-growing bacterium, M. gen. can be difficult to detect. Hologic’s Aptima Mycoplasma genitalium Assay is a nucleic acid amplification test that detects M. gen. in urine, urethral, penile-meatal, endocervical, or vaginal swab samples. This assay helps achieve accurate detection of the STI via a highly sensitive and specific diagnostic method for identifying infection.
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