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# New Hologic Test Cleared for STI Mycoplasma genitalium
- URL: https://www.fdaweb.com/new-hologic-test-cleared-for-sti-mycoplasma-genitalium/
- Published: 2019-01-24T12:00:00.000Z
- Updated: 2026-09-15T00:57:00.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143215

FDA has cleared a Hologic *de novo* submission for the Aptima *Mycoplasma genitalium* Assay, a new test to aid in the diagnosis of the sexually-transmitted infection called *Mycoplasma genitalium* (*M. gen.*). This is the first test authorized by the agency to test for this 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. The nucleic acid amplification test is intended to detect *M. gen.* in urine, urethral, penile meatal, endocervical or vaginal swab samples collected in a doctor’s office or clinic.

*De novo* clearance is based on data from a clinical study that included testing of 11,774 samples, according to an [FDA release](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm629746.htm?ref=fdaweb.com). The study showed that the assay correctly identified *M. gen.* in about 90% of vaginal, male urethral, male urine and penile samples. “It correctly identified *M. gen.* in female urine and endocervical samples 77.8% of the time and 81.5% of the time, respectively,” the agency says.