News

SpeeDx Receives CE-IVD Clearance for ResistancePlus® MG FleXible

ResistancePlus® MG FleXible for the Cepheid GeneXpert® System is now CE-IVD and available for sale in Europe. The test detects the sexually transmitted infection (STI) Mycoplasma genitalium (Mgen) and markers associated with azithromycin resistance, and is the first to be launched under Cepheid’s FleXible Cartridge programme.

ResistancePlus® MG FleXible is a near-patient test providing clinically relevant information to help manage the growing problem of macrolide resistance in Mgen infections.

“SpeeDx offers unique technology for simultaneous detection of pathogens and drug resistance directly from clinical specimens. Together, we have leveraged the open architecture of our new FleXible cartridge to enable detection of this emerging drug-resistant pathogen on the GeneXpert System,” said David H. Persing, M.D., Ph.D., Cepheid’s Chief Medical and Technology Officer.

Timely detection of antibiotic resistant infections enables Resistance Guided Therapy, resulting in better treatment of the disease for patients, reduced potential for spreading infection among vulnerable populations, and supporting antibiotic stewardship to combat rising antibiotic resistance.

Read the full press release.