Advertisement
Aptima®
Mycoplasma genitalium Assay from Hologic
is the First and Only FDA-Cleared Diagnostic Test to Detect This Emerging Health Threat
FDA clearance makes clinically validated assay available for sexually-transmitted infection listed as emerging threat by the CDC.
The U.S. Food and Drug Administra- tion recently granted clearance for the first and only FDA-cleared test for detection of Mycoplasma genitalium, an under-recognized but increasingly common sexually transmitted infection (STI). The Aptima® Mycoplasma geni- talium assay from Hologic, Inc., cleared through the FDA’s De Novo request process, provides laboratories with a highly sensitive and specific molecular diagnostic method to identify infec- tions and enable effective treatment.
First discovered in the early 1980s, Mycoplasma genitalium (M. genitali- um) was listed as an emerging public health threat by the U.S. Centers for Disease Control and Prevention (CDC) in 2015. Current estimates indicate that M. genitalium may affect more than 15 percent of men and women in certain high-risk populations, and its prevalence is growing. Because of the lack of an FDA-cleared test until now, M. genitalium has often been misdiag- nosed as other STIs and, in some cas- es, treated with the wrong antibiotics. This often leaves the underlying infection untreated, which can lead to increased transmission and recurrent infections.
“Although Mycoplasma genitalium is typically more common than gonor- rhea, there is very little public aware- ness of this rising sexually transmitted infection, which can cause serious and potentially devastating health
problems,” said Tom West, president, Diagnostic Solutions at Hologic. “The introduction of the Aptima Mycoplasma genitalium assay gives healthcare pro- fessionals the opportunity to provide optimal care for their patients and re- flects Hologic’s commitment to devel- oping innovative solutions that address emerging public health threats.”
In men, M. genitalium symptoms may include urethritis, the swelling and inflammation of the urethra. In women, M. genitalium has been linked to cervi- citis, the swelling and inflammation of the cervix. If left untreated, infections can lead to infertility in women and increased risk of HIV acquisition and transmission.2
Patients infected with
M. genitalium may be asymptomatic or experience symptoms similar to those associated with a chlamydial infection, so accurate diagnostic tests are critical to help healthcare professionals and their laboratory partners identify these bacterial infections and treat them appropriately. Research has shown as many as 50 percent of women and 42 percent of men with M. genitalium may have an antibiotic-resistant strain, further emphasizing the importance of early detection and regular screening.3
In published research, Hologic’s ribosomal RNA-based M. genitalium assay displayed greater sen- sitivity than lab-developed or CE-marked DNA-based tests.7,8 Hologic introduced the first
* The Aptima Zika Virus assay has not been FDA cleared or approved; this test has been authorized by FDA under an EUA for use by authorized laboratories; this test has been authorized only for the detection of RNA from Zika virus and diagnosis of Zika virus infection, not for any other viruses or pathogens; and this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection under section 564(b) (1) of the Act, 21 U.S.C.§ 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. For additional availability in other countries beyond the U.S., please contact your local sales representatives or distributor.
References: 1. Tully JG, Taylor-Robinson D, Cole RM, et al. A newly discovered mycoplasma in the human urogenital tract. Lancet 1981;1: 1288–91. 2. CDC. 2015 Sexually Transmitted Diseases Treatment Guidelines. Emerging Issues.
https://www.cdc.gov/std/tg2015/emerging.htm. Updated June 4, 2015. Accessed April 11, 2019. 3. 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. 4. Horner P, Martin D. Mycoplasma genitalium infection in men. Journal of Infectious Diseases. 2017. 216 (Suppl 2), S396. 5. Wiesenfeld H, Manhart L. Mycoplasma genitalium in Women: Current knowledge and research priorities for this recently emerged pathogen. Journal of Infectious Diseases. 2017. 216 (Suppl 2), S389. 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. 7. Unemo M, Salado-Rasmussen K, Hansen M, et al. Clinical and analytical evaluation of the new Aptima Mycoplasma genitalium assay, with data on M. genitalium prevalence and antimicrobial resistance in M. genitalium in Denmark, Norway and Sweden in 2016. Clinical Microbiology and Infection. 2018. 24, 533-539. 8. Le Roy C, Pereyre S, Henin N, et al. French Prospective Clinical Evaluation of the Aptima Mycoplasma genitalium CE-IVD Assay and Macrolide Resistance Detection Using Three Distinct Assays. Journal of Clinical Microbiology. 2017. 55, 3194-3200. 9. Hologic internal estimate. 10. Open channel functionality on the Panther Fusion system is a non-IVD function, which is not cleared or approved by the FDA.
© 2019 Hologic, Inc.
FDA-cleared diagnostic test kit for STIs in the 1990s using its innovative RNA-based technology. Since then, Hologic has expanded its Aptima STI portfolio to include assays for chlamyd- ia, gonorrhea, human papillomavirus (HPV), herpes simplex viruses (HSV 1 & 2), trichomonas, and Zika* virus. The Aptima virology portfolio also includes quantitative assays for the human immunodeficiency virus (HIV) and hep- atitis B and C (HBV and HCV). All are available on Hologic’s fully-automated Panther® system. In 2017, the Aptima assays helped an estimated 40 million patients obtain fast, high-quality test results.9
Including the first IVD for the detection of Mycoplasma genitalium, Hologic’s Panther and Panther Fusion® sys- tem now offers 14 FDA-cleared or approved assays that detect more than 20 pathogens, making it the only high-throughput molecular diagnos- tic platform in the United States to combine comprehensive sexual health, cervical health, viral load, respiratory testing and open channel10
functional- ity on a fully automated system.
For more information on the Aptima assays, visit
HealthDxS.com.
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52
