SpeeDx’s ResistancePlus MG FleXible Receives CE-IVD Clearance for Detection of Sexually Transmitted Infection (STI)

SpeeDx’s ResistancePlus MG FleXible Receives CE-IVD Clearance for Detection of Sexually Transmitted Infection (STI)

Shots:

  • ResistancePlus MG FleXible is used for Cepheid GeneXpert System diagnosing STI Mycoplasma genitalium (Mgen) and markers associated with azithromycin resistance currently approved for sales in EU
  • SpeeDx collaborated with Cepheid providing Resistance Guided Therapy for Mgen on the GeneXpert sample-to-answer ResistancePlus MG FleXible assay, the first test to be launched in Cepheid’s FleXible Cartridge program. Cepheid will be responsible for distribution of the assay
  • The assay is open-platform easy-to-use on demand format approved for sales in EU as well as in Australia and is expected for the US FDA submission. Additionally, SpeeDx offers technology for simultaneous detection of pathogens and drug resistance directly from clinical specimens

Click here to read full press release/ article | Ref: Business Wire | Image: Behance