SpeeDx Begins Multisite U.S. Clinical Trials of ResistancePlus® MG Test

Test supports international guidelines for treating antibiotic resistant STI

SYDNEY, Australia, Sept. 25, 2018 (GLOBE NEWSWIRE) — SpeeDx Pty. Ltd. today announced the start of patient testing in their multisite U.S.-based clinical trials for ResistancePlus® MG (not available for sale in the U.S.). The molecular diagnostic test detects the sexually transmitted infection (STI) Mycoplasma genitalium, also known as Mgen or MG, along with genetic markers linked to antibiotic resistance. In recent years, Mgen prevalence has increased globally and developed high rates of resistance to the common antibiotic treatment, azithromycin.

“This test is an exciting new development that will increase the precision of patient care for patients impacted by Mycoplasma genitalium – a common sexually transmitted infection with limited treatment options,” notes Dr Maria Trent, Professor of Pediatrics and Public Health at Johns Hopkins Medicine.

The SpeeDx ResistancePlus MG test is in use in laboratories across Europe, U.K., Australia, and New Zealand. However, there is not currently a U.S. Food and Drug Administration-cleared commercially available test for Mgen. SpeeDx is expecting clearance of ResistancePlus MG in 2019 with U.S. clinical trials now beginning at the University of Alabama at Birmingham, Johns Hopkins University, and TriCore Reference Laboratories.

“This is an important new test that has now influenced Mgen treatment guidelines in Europe1, the UK2, and Australia3,” said Colin Denver, CEO of SpeeDx. “We are delighted with the progress of our U.S. clinical trial sites and we are excited to be able to offer the test in the U.S. market in the near future.”

In a recent peer-reviewed study published in Clinical Infectious Diseases4, the authors recorded an overall cure rate of >92% when using Resistance Guided Therapy with the ResistancePlus MG test – a significant increase compared with previous cure rates below 60%. Resistance to azithromycin, a commonly recommended treatment for M. genitalium infection, has risen to over 50% in many countries around the world.5,6 Data from this study has already influenced recent STI management guideline updates in Australia3 and the United Kingdom2, with recommendations to assess the resistance status of M. genitalium infections in order to guide appropriate treatment. Using diagnostics to define appropriate treatment decisions results in a more effective use of antibiotics, curtails the use of inappropriate prescribing and helps preserve the use of key medicines needed to combat the global rise of antimicrobial resistance.

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.7 Like Neisseria gonorrhoeae, M. genitalium is also evolving into a so-called STI superbug that is becoming resistant to many antibiotic treatments leading to exceedingly difficult to treat infections and threatening global public health.8 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 50% in several countries.4-6 Due to this growing antibiotic resistance problem, several global STI Management Guidelines on M. genitalium Infections recommend complementing the use of molecular testing to detect M. genitalium with an assay capable of detecting macrolide resistance-associated mutations.1-3

About SpeeDx
Founded in 2009, SpeeDx is an Australian-based private company with offices in London and the US, and distributors across Europe. SpeeDx specializes in molecular diagnostic solutions that go beyond simple detection to offer comprehensive information for improved patient management. Innovative real-time polymerase chain reaction (qPCR) technology has driven market-leading multiplex detection and priming strategies. Product portfolios focus on multiplex diagnostics for sexually transmitted infection (STI), antibiotic resistance markers, and respiratory disease. For more information on SpeeDx please see: https://plexpcr.com

Jensen JS, Cusini M, Gomberg M, Moi H. 2016. 2016 European guideline on Mycoplasma genitalium infections. Journal of European Academy Dermatology & Venereology. PMID: 27505296.
https://www.bashhguidelines.org/media/1146/ngu-update-05_2017-final.pdf
http://www.sti.guidelines.org.au/sexually-transmissible-infections/mycoplasma-genitalium
Read T R H, Fairley C K, Murray G L, et al. Outcomes of resistance-guided sequential treatment of Mycoplasma genitalium infections: a prospective evaluation, Clinical Infectious Diseases, ciy477, https://doi.org/10.1093/cid/ciy477
Getman D, Jiang A, O’Donnell M, Cohen S. Mycoplasma genitalium prevalence, coinfection, and macrolide antibiotic resistance frequency in a multicenter clinical study cohort in the United States. Journal of Clinical Microbiology 2016; 54:2278-2283.
Murray GL, Bradshaw CS, Bissessor M, et al. Increasing Macrolide and Fluoroquinolone Resistance in Mycoplasma genitalium. Emerging Infectious Diseases. 2017; 23(5):809-812.
Miller WC, Ford CA, Morris M, et al. Prevalence of chlamydial and gonococcal infections among young adults in the United States. JAMA 2004; 291:2229–2236.
Unemo M & Jensen JS. Antimicrobial-resistant sexually transmitted infections: gonorrhoea and Mycoplasma genitalium. Nature Reviews Urology. 2017; 14:139-152.

Contacts:

Europe, Australia, New Zealand
Madeline O’Donoghue
madelineo@speedx.com.au
+61 2 9209 4170

United States
Rick Roose
roi.roose@gmail.com
+1.415.202.4445

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