Hologic, Inc. has been granted clearance for its Aptima Mycoplasma genitalium assay, the first and only FDA-cleared test for the detection of an increasingly common sexually transmitted infection (STI).
The new assay was cleared through the FDA’s de novo request process and offers a highly sensitive, specific diagnostic method to identify infections and enable effective treatment.
Mycoplasma genitalium (M. genitalium), which is more common than gonorrhea but is under-recognized, was listed as an emerging public health threat in 2015. Current estimates indicate that more than 15% of people in certain high-risk populations are affected, and its prevalence is growing.
The absence of an FDA-cleared test, until now, has caused M. genitalium to be misdiagnosed as other STIs. This has sometimes resulted in treatment with the wrong antibiotics, often leaving the underlying infection untreated, which can lead to further transmission and recurrent infections.
M. genitalium symptoms in men may include urethritis, and in women, it has been linked to cervicitis. Left untreated, infection can lead to infertility and a greater risk of HIV acquisition and transmission. As patients may be asymptomatic or have symptoms similar to chlamydia infection, reliable diagnostic tests are crucial for proper identification and treatment.
Source: BioSpace, January 23, 2019