SpeeDx Receives CE-IVD Mark for ResistancePlus™ MG
News Sep 22, 2016
SpeeDx Pty Ltd has announced that it has received CE-IVD marking for its ResistancePlus™ MG assay that detects both the sexually transmitted disease (STD) Mycoplasma genitalium (often referred to as M. genitalium or MG) and mutations in the 23S rRNA gene of the bacteria that have been shown to confer resistance to azithromycin, a commonly prescribed macrolide-based antibiotic. “We are excited to receive CE-IVD marking for this revolutionary new benchmark for M. genitalium and antibiotic resistance testing,” said Colin Denver, CEO for SpeeDx.
“As with the better known STD gonorrhoea, M. genitalium has developed serious treatment challenges because of the recent rise of antibiotic resistance.” “Testing for macrolide resistance mediating mutations in all positive samples is strongly recommended in the new 2016 European Guidelines on Mycoplasma genitalium Infections,” said Jørgen Jensen, MD, PhD, DMSc, lead author of the guidelines.
“With macrolide resistance levels exceeding 50 percent in some settings, it will improve patient management significantly to be able to select the optimal antimicrobial treatment immediately. Avoiding unnecessary use of azithromycin is also part of antimicrobial stewardship.” In the US, SpeeDx has entered into discussions with leading academic medical centers to conduct clinical trials of its ResistancePlus™ MG assay and plans to seek a Premarket Approval (PMA) from the US FDA in 2017.
Currently, there is not an FDA cleared molecular diagnostic test for M. genitalium in the US. In addition, the Centers for Disease Control and Prevention (CDC) have now entered into a Material Transfer Agreement (MTA) with SpeeDx to evaluate the performance of its ResistancePlus™ MG assay.