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 –

MARLBOROUGH, Mass.--(BUSINESS WIRE)--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). Published in the November issue of the Journal of Clinical Microbiology, the prospective, multi-center Aptima Mycoplasma genitalium Evaluation Study (AMES) is the first clinical study to validate the performance of Hologic’s (Nasdaq: HOLX) Aptima® Mycoplasma genitalium assay in the United States.¹

“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 Kevin Thornal, Hologic’s division president, Diagnostic Solutions. “Providing evidence of the assay’s efficacy further strengthens the case for physicians to consider including M. genitalium testing as part of the sexual health care they provide for their patients.”

Previously under-recognized, M. genitalium was first identified in 1981, and in 2015 was listed as an emerging public health issue by the U.S. Centers for Disease Control and Prevention (CDC).^2,3 Current estimates indicate that M. genitalium may affect more than 15 percent of women and men, and awareness of its prevalence is growing.⁴ In 2018, a study published in the journal Clinical Infectious Diseases referred to M. genitalium as “the silent epidemic.”⁵

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 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.^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 Damon Getman, Ph.D., study co-author, Hologic’s senior principal research scientist and director of research and development. “Conducting a prospective study across a wide range of sites from STI clinics to OB-GYN offices across the country helps the health care community learn more about M. genitalium infections and how to better identify them in all types of patients.”

Study Details

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 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 percent in women and 10.6 percent in men. The prevalence in symptomatic women and men was 11.6 percent and 12 percent, respectively. In asymptomatic women and men, the prevalence was 7.9 percent and 8.8 percent, 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 (>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 genitalium assay, visit https://healthdxs.com/en/.

About Hologic

Hologic, Inc. is an innovative medical technology company primarily focused on improving women’s health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com.

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. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such statements are based.

Hologic and Aptima are registered trademarks of Hologic, Inc. in the United States and/or other countries.

SOURCE: Hologic, Inc.

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1. 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.
2. Tully JG, Taylor-Robinson D, Cole RM, et al. A newly discovered mycoplasma in the human urogenital tract. Lancet 1981;1: 1288–91.
3. 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.
4. 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.
5. 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.
6. 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.