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SpeeDx Gets Health Canada Approval for Mycoplasma Genitalium ID, Drug Resistance Test

NEW YORK – A molecular diagnostic test kit from SpeeDx to detect the sexually transmitted infection Mycoplasma genitalium as well as genetic mutations conferring resistance to macrolides, a commonly-prescribed class of antibiotics, has been cleared by Health Canada.

The qPCR kit, called ResistancePlus MG, is the first test commercially available in Canada that can be used for both pathogen identification and therapy guidance, according to the Sydney, Australia-based firm.

"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," SpeeDx CEO Colin Denver said in a statement.

Currently, labs in Canada are guided to send samples to the National Microbiology Laboratory for resistance testing, but the new test could potentially allow them to bring testing in house.

ResistancePlus MG is already in use across Europe, the UK, Australia, and New Zealand, and SpeeDx noted that recent STI guideline updates in these regions recommend assessing resistance status of M. genitalium infections to guide appropriate treatment.

SpeeDx is currently finalizing clinical trials across the US in preparation for submission of the test to the US Food and Drug Administration later this year. The test is part of a planned line of multiplex STI and resistance tests, and the firm was recently granted breakthrough status by the FDA for its ID and resistance test for gonorrhea, ResistancePlus GC.