SOURCE: SpeeDx Pty. Ltd.

SpeeDx Pty. Ltd.

February 13, 2017 09:00 ET

Review published in Nature Reviews Urology advises antibiotic resistance testing for M. genitalium sexually transmitted infection and potential "superbug"; SpeeDx ResistancePlus™ MG Test only CE-marked commercial test available for this purpose

SYDNEY, AUSTRALIA--(Marketwired - Feb 13, 2017) - SpeeDx Pty. Ltd. today announced that the authors of the review, Antimicrobial-resistant sexually transmitted infections: gonorrhoea and Mycoplasma genitalium, published in Nature Reviews Urology http://www.nature.com/nrurol/journal/vaop/ncurrent/full/nrurol.2016.268.html, recommended that appropriate M. genitalium diagnostic testing become available on a routine basis in clinical practice and should ideally be supplemented with molecular detection for antibiotic resistance. Currently, SpeeDx has the only commercially available test capable of simultaneously detecting the sexually transmitted infection (STI) M. genitalium and antibiotic resistance status. SpeeDx ResistancePlus™ MG test is CE marked for sale in Europe and TGA approved for sale in Australia. SpeeDx plans to seek a de novo clearance for the test with the U.S. Food and Drug Administration this year.

"M. genitalium infections have become exceedingly difficult to treat, owing to the increasing levels of antimicrobial resistance or AMR," said review co-author Jorgen S. Jensen, MD, PhD, DMSc of the Statens Serum Institut in Denmark. "AMR testing as well as diagnostic tests for M. genitalium need to become routinely available if we are to substantially improve patient management of this STI and potential superbug."

"As this review points out, there is a great medical need to personalised treatment of M. genitalium.  The ResistancePlus™ MG test allows clinicians to make informed treatment decisions and to combat the spread of antibiotic resistance of this STI," said Colin Denver, CEO of SpeeDx. "We look forward to increasing the availability of this assay in clinical laboratories throughout Europe and Australia. In the US, we have entered into discussions with leading academic medical centers to conduct clinical trials of the ResistancePlus™ MG test and plan to seek a de novo clearance from the US FDA later this year."

About M. genitalium
M. genitalium is a sexually transmitted infection (STI) that can cause symptoms such as urethritis, cervicitis, endometritis and pelvic inflammatory disease. In recent studies, it has been found to have a higher prevalence than Gonorrhea. Like Gonorrhea, M. genitalium is also evolving into a so-called STI superbug that is becoming resistant to many antibiotic treatments causing exceedingly difficult to treat infections and threatening global public health. Macrolide antibiotics, specifically azithromycin, are the first-line treatment for the rapidly growing problem of M. genitalium STIs, but resistance to these antibiotics has increased up to 40% in several countries.1-3 Due to this growing antibiotic resistance problem, in 2016 the European Guideline on M. genitalium Infections recommended complementing the molecular detection of M. genitalium with an assay capable of detecting macrolide resistance-associated mutations.4

Currently, there is not a Food & Drug Administration (FDA) cleared molecular diagnostic test for the detection of M. genitalium in the USA. The SpeeDx ResistancePlus™ MG assay is CE marked for sale in Europe and TGA approved for sale in Australia. The test provides valuable detection and antibiotic resistance information to clinicians in a rapid time. Timely detection of antibiotic resistant infections enables better treatment of the disease for patients, lessens the potential for spreading among vulnerable populations and combats antibiotic resistance.

About SpeeDx
Based in Sydney, Australia and founded in 2009, SpeeDx is a privately owned company specializing in innovative multiplex real-time polymerase chain reaction (qPCR) solutions for clinical diagnostics. SpeeDx has a portfolio of market leading detection and priming technologies to enable new healthcare paradigms based on improved delivery and reduced costs. SpeeDx has a proven track record of scientific discovery and strives to provide cutting edge clinically relevant tools for the clinical diagnostic market. For more information on SpeeDx please see: http://www.speedx.com.au/

1. Salado-Rasmussen K, Jensen JS. 2014. Mycoplasma genitalium testing pattern and macrolide resistance: A Danish nationwide retrospective survey. Clin Infect Dis 59:24-30.
2. Tagg KA, Jeoffreys NJ, Couldwell DL, Donald JA, Gilbert GL. 2013. Fluoroquinolone and macrolide resistance-associated mutations in Mycoplasma genitalium. J Clin Microbiol 51:2245-2249.
3. Getman D, Jiang A, O'Donnell M, Cohen S. 2016. Mycoplasma genitalium prevalence, coinfection, and macrolide antibiotic resistance frequency in a multicenter clinical study cohort in the United States. J Clin Microbiol 54:2278-2283.
4. Jensen JS, Cusini M, Gomberg M, Moi H. 2016. 2016 European guideline on Mycoplasma genitalium infections. J Eur Acad Dermatol Venereol. PMID: 27505296.

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