SpeeDx Receives Clearance from Health Canada for ResistancePlus® MG Test

SpeeDx Pty. Ltd. today announced Resistance Plus® MG has been cleared by Health Canada and is now available for sale across all Canadian provinces (not currently available in the U.S.). The molecular diagnostic test detects the sexually transmitted infection (STI) Mycoplasma genitalium, also known as Mgen, along with genetic markers linked to antibiotic resistance. This is the first commercially available test in Canada combining identification and therapeutic guidance information to support Resistance Guided Therapy for management of Mgen.

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Current Canadian management guidelines for Mgen direct laboratories to forward positive samples to the National Microbiology Laboratory for resistance testing.¹ Now Canadian laboratories can utilize Resistance Plus MG and bring this service inhouse to generate more timely results for doctors and their patients.

"SpeeDx tests are designed to empower clinicians to make informed treatment decisions,” said Colin Denver, SpeeDx CEO. “Bringing Resistance Plus MG to Canada allows even more clinicians to access Resistance Guided Therapy, helping to improve patient cure rates and reduce overall health care costs.”

Resistance to azithromycin, a commonly recommended treatment for Mgen infection, has been rising where empiric treatment or Mgen detection only practices have predominated.² A groundbreaking paper using Resistance Plus MG as part of a Resistance Guided Therapy protocol reported significant success - improving cure rates from below 60% to over 92%.² Resistance Plus MG is already in use across Europe, U.K., Australia, and New Zealand, where recent STI management guideline updates recommend assessing the resistance status of Mgen infections in order to guide appropriate treatment.^3-5

There is not currently a U.S. Food and Drug Administration (FDA) -cleared commercially available test for the combined detection of M. genitalium and macrolide resistance markers. SpeeDx is finalizing clinical trials across the U.S. in preparation for FDA submission later this year. The FDA also recently granted breakthrough status for the SpeeDx Resistance Plus^® GC test, supporting Resistance Guided Therapy for gonorrhea infections.⁶ Resistance Plus GC provides information on ciprofloxacin susceptibility/resistance, giving doctors and patients the option of using ciprofloxacin instead of ceftriaxone, one of the last remaining antibiotics available for multi-drug resistant gonorrhoea infections.

“Our Resistance Plus tests represent a new way of using diagnostics, providing more information on the infecting organism,” adds Denver. “The availability of this kind of testing has now influenced Mgen treatment guidelines around the world and we are delighted with this new registration for Canada as well as the prospect of offering this and other similar tests in the U.S. market in the near future.”

About M. genitalium (Mgen)

M. genitalium is a 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, Mgen 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 but resistance to these antibiotics has increased.^1,9,10 Due to this growing antibiotic resistance problem, several global STI Management Guidelines on Mgen infections recommend complementing the use of molecular testing to detect M. genitalium with an assay capable of detecting macrolide resistance-associated mutations.^2-4

About SpeeDx

SpeeDx has developed a molecular diagnostics test portfolio for infectious diseases that provides identification of infecting organism and therapeutic guidance capabilities. The company is based in Australia with offices in Austin and London, 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 infections (STIs), antibiotic resistance markers, and respiratory disease. For more information about SpeeDx please see: https://plexpcr.com

1. https://www.canada.ca/en/public-health/services/infectious-diseases/sexual-health-sexually-transmitted-infections/canadian-guidelines/sexually-transmitted-infections/canadian-guidelines-sexually-transmitted-infections-49.html
2. Read T R H, et al. CID 2019; 68(4):554-560
3. https://www.bashhguidelines.org/media/1146/ngu-update-05_2017-final.pdf
4. http://www.sti.guidelines.org.au/sexually-transmissible-infections/mycoplasma-genitalium
5. Jensen JS, et al. 2016.PMID: 27505296.
6. https://www.businesswire.com/news/home/20190611005313/en/SpeeDx-Receives-FDA-Breakthrough-Designation-ResistancePlus%C2%AE-GC
7. Miller WC et al. JAMA 2004; 291:2229–2236.
8. Unemo M & Jensen JS. Nat Rev Urol. 2017; 14:139-152.
9. Getman D et al. J Clin Micro 2016; 54:2278-2283.
10. Murray GL et al. Emerg Infect Dis 2017; 23(5):809-812.

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Contact information

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

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