SpeeDx Pty Ltd, Sydney, has received the CE mark for its ResistancePlus MG assay, which detects both the sexually transmitted disease (STD) Mycoplasma genitalium (MG) and mutations in the 23S rRNA gene of the bacterium, which have been shown to confer resistance to azithromycin, a commonly prescribed macrolide-based antibiotic.
Colin Denver, SpeeDx.
“We are excited to receive CE-IVD marking for this revolutionary new benchmark for M. genitalium and antibiotic resistance testing,” says Colin Denver, CEO of SpeeDx. “As with the better known STD gonorrhoea, M. genitalium has developed serious treatment challenges because of the recent rise of antibiotic resistance.”
M. genitalium is a sexually transmitted infection that can cause such symptoms as cervicitis, endometriosis, pelvic inflammatory disease, and urethritis.1 In recent studies, it has been found to have a higher prevalence than Neisseria gonorrhoeae, and has also been shown to have increasing treatment failure rates due to antimicrobial resistance to such macrolide-based antibiotics as azithromycin.2,3,4 With widespread macrolide resistance in Europe, new guidelines for 2016 strongly recommend that all positive tests for M. genitalium be followed up with an assay capable of detecting macrolide resistance-mediating mutations.5
“Testing for macrolide resistance-mediating mutations in all positive samples is strongly recommended in the new 2016 European guidelines on Mycoplasma genitalium infections,” says Jørgen Jensen, MD, PhD, DMSc, lead author of the guidelines. “With macrolide resistance levels exceeding 50% in some settings, it will improve patient management significantly to be able to select the optimal antimicrobial treatment immediately. Avoiding unnecessary use of azithromycin is also part of antimicrobial stewardship.”
In a recent study of the ResistancePlus MG assay, 56% of M. genitalium positive samples in the study carried a macrolide resistance mutation.6 Broad-spectrum antibiotics, including azithromycin therapy, would not have been an effective treatment for these patients.
In the United States, SpeeDx has entered into discussions with leading academic medical centers to conduct clinical trials of the ResistancePlus MG assay. In addition, the US Centers for Disease Control and Prevention has entered into a material transfer agreement with SpeeDx to evaluate performance of the assay. The company plans to seek FDA premarket approval during 2017. Currently, there is no FDA-authorized molecular diagnostic test for M. genitalium.
For more information, visit SpeeDx.
REFERENCES
- Sexually transmitted infections (STIs): the importance of a renewed commitment to STI prevention and control in achieving global sexual and reproductive health [online]. Geneva: World Health Organization, 2013. Available at: http://apps.who.int/iris/bitstream/10665/82207/1/who_rhr_13.02_eng.pdf. Accessed October 28, 2016.
- Sonnenberg P, Ison CA, Clifton S, et al. Epidemiology of Mycoplasma genitalium in British men and women aged 16–44 years: evidence from the third National Survey of Sexual Attitudes and Lifestyles (Natsal-3). ?Int J Epidemiol. 2015;44(6):1982–1994; doi: 10.1093/ije/dyv194.
- Manhart LE, Gillespie CW, Lowens MS, et al. Standard treatment regimens for nongonococcal urethritis have similar but declining cure rates: a randomized controlled trial. Clin Infect Dis. 2013;56(7):934–942; doi: 10.1093/cid/cis1022.
- Jensen JS, Bradshaw CS, Tabrizi SN, et al. Azithromycin treatment failure in Mycoplasma genitalium–positive patients with nongonococcal urethritis is associated with induced macrolide resistance. Clin Infect Dis. 2008;47(12):1546–1553; doi: 10.1086/593188.
- Jensen JS, Cusini M, and Gomberg M. 2016 European guideline on Mycoplasma genitalium infections [online]. International Union Against Sexually Transmitted Infections, 2016. Available at: iusti.org/regions/europe/pdf/2016/2016europeanmycoplasmaguidelines.pdf. Accessed October 28, 2016.
