Policy & Regulation
Newly Published Research Demonstrates Ability of Hologic's Assay to Detect Mycoplasma Genitalium, "the Silent Epidemic"
14 November 2019 - - A newly published study demonstrates clinical evidence for the effectiveness of a first-of-its-kind, FDA-cleared assay for the detection of the sexually transmitted bacterium Mycoplasma genitalium (M. genitalium), medical technology company Hologic said.
Published in the November issue of the Journal of Clinical Microbiology, the prospective, multi-center Aptima Mycoplasma genitalium Evaluation Study is the first clinical study to validate the performance of Hologic's (NASDAQ: HOLX) Aptima Mycoplasma genitalium assay in the United States.
Previously under-recognized, M. genitalium was first identified in 1981, and in 2015 was listed as an emerging public health issue by the US Centers for Disease Control and Prevention.
Current estimates indicate that M. genitalium may affect more than 15% of women and men, and awareness of its prevalence is growing.
In 2018, a study published in the journal Clinical Infectious Diseases referred to M. genitalium as "the silent epidemic."
Patients infected with M. genitalium may be asymptomatic or experience symptoms similar to those associated with other sexually transmitted infections such as chlamydia, for which the prevalence rate is similar. The AMES study showed that M. genitalium prevalence was high in both symptomatic and asymptomatic women and men.
This is why accurate diagnostic tests such as the Aptima Mycoplasma genitalium assay are critical in helping healthcare professionals and their laboratory partners identify and treat specific bacterial infections.
If left untreated, M. genitalium infections can lead to infertility in women and increased risk of HIV acquisition and transmission.
The study evaluated 3,300 sexually active women and men between the ages of 15 and 82 at 21 sites across the US between July 2017 and April 2018.
Subjects were enrolled at STI clinics, clinical research centers, and emergency medicine, family planning, public health, STI and family medicine/obstetric-gynecologic sites.
The study evaluated prevalence, sensitivity, specificity, positive predictive value, and negative predictive value for the Aptima assay compared to a composite molecular reference standard. M. genitalium prevalence was 10.1% in women and 10.6% in men. The prevalence in symptomatic women and men was 11.6% and 12%, respectively. In asymptomatic women and men, the prevalence was 7.9% and 8.8%, respectively.
Results showed that for each of seven specimen types, Aptima assay results aligned closely with results obtained with the composite reference standard.
Highest clinical sensitivity was observed for vaginal swab and male urethral swab specimens.
Performance differed by specimen type, which is detailed in the publication.
These results will allow clinicians to confidently choose the specimen type (e.g., urine, vaginal) most appropriate for their patients.
In addition, the availability and verified effectiveness of the Aptima Mycoplasma genitalium assay means laboratories no longer need to validate laboratory-developed tests for detection of the organism.
Hologic, Inc. is a medical technology company primarily focused on improving women's health and well-being through early detection and treatment.
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