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10th September 2019  Product update: rapidmicrobiology staff writer

SpeeDx Receives CE-IVD Clearance for ResistancePlus® MG FleXible


1937_Speedx_MacrolideResistanceTesting_

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.


    

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Date Published: 10th September 2019

Source article link: rapidmicrobiology staff writer

Note: This content has been edited by a rapidmicrobiology staff writer for style and content.


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