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Evaluation of SpeeDx’s CE-marked ResistancePlus™ MG test for M. genitalium published in Journal of Clinical Microbiology

ResistancePlus™ MG rapidly and reliably detects the disease and determines antibiotic resistance of this increasingly resistant sexually transmitted infection.

SpeeDx Pty. Ltd. announced that the study, “Evaluation of a commercial multiplex PCR assay for simultaneous detection of Mycoplasma genitalium and macrolide resistance-associated mutations in clinical specimens”, by Chloe Le Roy, Nadège Henin, Cecile Bebear and Sabine Pereyre has been accepted for publication by the Journal of Clinical Microbiology.
The authors concluded: “The ResistancePlus MG kit is a rapid and reliable method to simultaneously detect M. genitalium and determine macrolide resistance in clinical specimens.”
Macrolide antibiotics are the first-line treatment for the rapidly growing problem of M. genitalium STIs, but resistance to these antibiotics has increased up to 40% in several countries. Because of this growing antibiotic resistance problem, in 2016 the European guideline on M. genitalium infections recommended complementing the molecular detection of M. genitalium with an assay capable of detecting macrolide resistance-associated mutations.

“This is yet another demonstration of the value and reliability of the SpeeDx ResistancePlus™ MG test,” said Colin Denver, CEO of SpeeDx. “We look forward to increasing the availability of this assay in clinical laboratories throughout Europe. In the US, we have entered into discussions with leading academic medical centers to conduct clinical trials of ResistancePlus™ MG and plan to seek a de novo clearance from the US FDA in 2017.”

Currently, there isn’t a Food & Drug Administration (FDA) cleared molecular diagnostic test for M. genitalium in the US. The SpeeDx assay provides valuable information to clinicians in a rapid timeframe allowing for better treatment of patients infected with M. genitalium. Timely detection of potential antibiotic resistance will enable the development of better algorithms for the treatment of M. genitalium infection and promote responsible stewardship of antibiotics.

The ResistancePlus™ MG assay was evaluated in 206 male and female urogenital specimens including 94 M. genitalium-positive and 112 M. genitalium-negative specimens collected in 2014-2015 at the Bordeaux University hospital (France). The concordance between the results of ResistancePlus™ MG kit and the M. genitalium patient status was 99.5% with a kappa value of 0.98. The clinical sensitivity and specificity were 98.9% and 100% respectively. Overall, the concordance between the ResistancePlus™ MG kit results and the macrolide resistance status was 95.6% with a kappa value of 0.88. As previously reported, the clinical sensitivity and specificity of the kit were 95.4% and 95.8%, respectively.

View the full original press release here