SpeeDx announced ResistancePlus MG has been cleared by Health Canada and is now available for sale across all Canadian provinces (not currently available in the U.S.).
Image: SpeeDx has secured clearance from Health Canada for ResistancePlus MG test. Photo: courtesy of Business Wire.
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.
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 ResistancePlus 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 ResistancePlus 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.
A groundbreaking paper using ResistancePlus MG as part of a Resistance Guided Therapy protocol reported significant success – improving cure rates from below 60% to over 92%.2 ResistancePlus 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.
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 ResistancePlus® GC test, supporting Resistance Guided Therapy for gonorrhea infections.6 ResistancePlus 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 ResistancePlus 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.”
Source: Company Press Release