Newly Published Research Demonstrates Ability of Hologic’s Assay to Detect Mycoplasma Genitalium, “the Silent Epidemic”
– First FDA-cleared test for this sexually transmitted bacterium can lead to earlier detection and appropriate treatment –
“This study advances the scientific and medical understanding of M. genitalium and underscores our commitment to providing solutions to the public health threat it poses,” said
Previously under-recognized, M. genitalium was first identified in 1981, and in 2015 was listed as an emerging public health issue by the
Patients infected with M. genitalium may be asymptomatic or experience symptoms similar to those associated with other sexually transmitted infections (STIs) 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 genitaliumassay 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.3,6
“M. genitalium often has been misdiagnosed as other STIs then treated with the wrong antibiotics, leaving the underlying infection untreated, which can lead to increased transmission, recurrent infections, emergence of antibiotic resistant strains, and potential health complications,” said
The study evaluated 3,300 sexually active women and men between the ages of 15 and 82 at 21 sites across the U.S. between
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 (>98%) 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.1 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.
For more information on the Aptima Mycoplasma genitaliumassay, visit https://healthdxs.com/en/.
Hologic Forward-Looking Statements
This press release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic’s diagnostic products. There can be no assurance these products will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient. The actual effect of the use of the products can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. In addition, there can be no assurance that these products will be commercially successful or achieve any expected level of sales.
Gaydos CA, Manhart LE, Taylor SN, Lillis RA, Hook EW, III, Klausner JD, Remillard CV, Love M, McKinney B, Getman DK, on behalf of the
AMES Clinical Study Group. 2019. Molecular testing for Mycoplasma genitalium in the United States: results from the AMES prospective multicenter clinical study. J Clin Microbiol 57:e01125-19. https://doi.org/10 .1128/JCM.01125-19.
- Tully JG, Taylor-Robinson D, Cole RM, et al. A newly discovered mycoplasma in the human urogenital tract. Lancet 1981;1: 1288–91.
CDC. 2015 Sexually Transmitted Diseases Treatment Guidelines. Emerging Issues. https://www.cdc.gov/std/tg2015/emerging.htm. Updated
June 4, 2015. Accessed December 7, 2018.
Getman D, Jiang A, O’Donnell M, et al. Mycoplasma genitalium Prevalence, Coinfection, and Macrolide Antibiotic Resistance Frequency in a Multicenter Clinical Study Cohort in
the United States. Journal of Clinical Microbiology. 2016; 54(9):2278-2283.
Arlene C Seña, Jeannette Y Lee,
Jane Schwebke, Susan S Philip, Harold C Wiesenfeld, Anne M Rompalo, Robert L Cook, Marcia M Hobbs, A Silent Epidemic: The Prevalence, Incidence and Persistence of Mycoplasma genitalium Among Young, Asymptomatic High-Risk Women in the United States, Clinical Infectious Diseases, Volume 67, Issue 1, 1 July 2018, Pages 73–79, https://doi.org/10.1093/cid/ciy025.
Gatski M, Martin DH, Theall K, et al. Mycoplasma genitalium infection among HIV-positive women: prevalence, risk factors and association with vaginal shedding.
International Journal of STD & AIDS. 2011; 22: 155–159.
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