Cepheid is the exclusive distribution partner of this test, available through Cepheid’s FleXible Cartridge programme for the GeneXpert System
SpeeDx announced the European launch of ResistancePlus MG FleXible, the first sample-to-answer test for detecting the sexually transmitted infection (STI) Mycoplasma genitalium (Mgen) and markers associated with azithromycin resistance.
Cepheid is the exclusive distribution partner of this test, available through Cepheid’s FleXible Cartridge programme for the GeneXpert System.
Management guidelines around the world, including those recently updated in France1 and the U.K.2, reference testing the macrolide resistance status of Mgen infections in order to more effectively treat patients.
Mgen can cause symptoms such as urethritis, cervicitis, endometritis and pelvic inflammatory disease, and has been linked to reproductive health complications including pre-term birth and infertility.2,3 Due to the challenges of rising antimicrobial resistance and a lack of clear data that asymptomatic infection leads to protracted health complications, Mgen testing guidelines are unanimous in their recommendation to only test symptomatic individuals.
“This is an important test expansion for the thousands of GeneXpert Systems on the market,” said Colin Denver, SpeeDx CEO. “ResistancePlus MG FleXible enables Resistance Guided Therapy, supporting more clinicians to adhere to testing guidelines and maximising effective care for their patients infected with Mgen.”
SpeeDx has developed a molecular diagnostics test portfolio, principally for infectious diseases, that provides both identification as well as 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. The SpeeDx ResistancePlus® MG open-platform assay is CE marked for sale in Europe, TGA approved for sale in Australia and clinical trials are being finalised for submission to the U.S. FDA. Products in the SpeeDx portfolio focus on multiplex diagnostics for sexually transmitted infection (STI), antibiotic resistance markers, and respiratory disease.
Source: Company Press Release