Called Aptima, it is the first test to be cleared by the FDA for M. genitalium, which is associated with inflammation of the urethra (nongonococcal urethritis) in men and inflammation of the cervix (cervicitis) and infection of the reproductive organs (pelvic inflammatory disease) in women.
The assay was cleared under the FDA's de novo pathway, a new regulatory path the agency designed for devices of low to moderate risk. The FDA's move creates a new regulatory classification that can be useful in the future for similar products.
M. genitalium is responsible for approximately 15% to 30% of persistent or recurrent urethritis cases in men in the U.S. and 10% to 30% of cervicitis cases in women. The bacterium is slow-growing and hard to detect with traditional laboratory methods, the FDA noted.
Hologic's Aptima assay is a nucleic acid amplification test that detects M. genitalium in urine or urethral, penile meatal, endocervical, or vaginal swab samples collected in a clinical setting, such as a doctor's office or clinic. As part of its regulatory submission, Hologic provided data from 11,774 samples that showed that Aptima correctly identified M. genitalium in about 90% of vaginal, male urethral, male urine, and penile samples. The assay correctly identified M. genitalium in female urine samples 77.8% of the time and in endocervical samples 81.5% of the time.
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