10th September 2019 Product update: rapidmicrobiology staff writer
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.
ResistancePlus® MG FleXible will be exclusively distributed by Cepheid.
For more information on SpeeDx visit: plexpcr.com
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.
Date Published: 10th September 2019
Source article link: https://plexpcr.com/2019/09/06/resistanceplus-mg-flexible-ce-ivd/
Note: This content has been edited by a rapidmicrobiology staff writer for style and content.
PerkinElmer Launches EUROIMMUN Aspergillus Antigen
ARUP Laboratories Deploys World’