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

SYDNEY, AUSTRALIA--(Marketwired - Jan 9, 2017) - 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 He�nin, Ce�cile Be�bear and Sabine Pereyre has been accepted for publication by the Journal of Clinical Microbiology. http://jcm.asm.org/content/early/recent

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.^1-3 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.⁴

"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.⁵

About M. genitalium
M. genitalium is a sexually transmitted infection that can cause symptoms such as urethritis, cervicitis, endometriosis and pelvic inflammatory disease. In recent studies, it has been found to have a higher prevalence than Neisseria gonorrhoeae and has been shown to have increasing treatment failure rates due to antimicrobial resistance to macrolide based antibiotics such as azithromycin. M. genitalium is often misdiagnosed because its symptoms are similar to other sexually transmitted diseases and PCR testing is not widely available. Because of this, doctors usually send patient samples to a special laboratory and prescribe a broad-spectrum antibiotic while they wait for their patients' results to come back. Meanwhile, patients with antibiotic resistant M. genitalium needlessly suffer continued infection and can transmit the infection to partners.

About SpeeDx
Based in Sydney, Australia and founded in 2009, SpeeDx is a privately owned company specializing in innovative multiplex real-time polymerase chain reaction (qPCR) solutions for clinical diagnostics. SpeeDx has a portfolio of market leading detection and priming technologies to enable new healthcare paradigms based on improved delivery and reduced costs. SpeeDx has a proven track record of scientific discovery and strives to provide cutting edge clinically relevant tools for the clinical diagnostic market. For more information on SpeeDx please see: http://www.speedx.com.au/

1. Salado-Rasmussen K, Jensen JS. 2014. Mycoplasma genitalium testing pattern and macrolide resistance: A Danish nationwide retrospective survey. Clin Infect Dis 59:24-30.
2. Tagg KA, Jeoffreys NJ, Couldwell DL, Donald JA, Gilbert GL. 2013. Fluoroquinolone and macrolide resistance-associated mutations in Mycoplasma genitalium. J Clin Microbiol 51:2245-2249.
3. Getman D, Jiang A, O'Donnell M, Cohen S. 2016. Mycoplasma genitalium prevalence, coinfection, and macrolide antibiotic resistance frequency in a multicenter clinical study cohort in the United States. J Clin Microbiol 54:2278-2283.
4. Jensen JS, Cusini M, Gomberg M, Moi H. 2016. 2016 European guideline on Mycoplasma genitalium infections. J Eur Acad Dermatol Venereol. PMID: 27505296.
5. Tabrizi SN, Tan LY, Walker S, Twin J, Poljak M, Bradshaw CS, Fairley CK, Bissessor M, Mokany E, Todd AV, Garland SM. 2016. Multiplex assay for simultaneous detection of Mycoplasma genitalium and macrolide resistance using PlexZyme and PlexPrime technology. PLoS One 11:e0156740.