SpeeDx Receives CE-IVD Mark for ResistancePlus(TM) MG

SYDNEY, AUSTRALIA--(Marketwired - Sep 19, 2016) - SpeeDx Pty. Ltd. announced today 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.

About M. genitalium
M. genitalium (also defined as M. genitalium or MG) is a sexually transmitted infection that can cause symptoms such as urethritis, cervicitis, endometriosis and pelvic inflammatory disease.¹ It has been found to have a higher prevalence than Neisseria gonorrhoeae in recent studies^2,3 and has shown to have increasing treatment failure rates due to antimicrobial resistance to macrolide based antibiotics such as azithromycin⁴. With widespread macrolide resistance in Europe, new guidelines for 2016 strongly recommend that all positive tests for M. genitalium be followed up with an assay capable of detecting macrolide resistance mediating mutations.⁵

M. genitalium is often misdiagnosed because its symptoms are similar to other sexually transmitted infections and diseases, and PCR testing is not widely available. Because of this, doctors are forced to 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 resistant M. genitalium needlessly suffer continued infection and risk spreading the resistant strain through continued sexual contact. In a recent study of the ResistancePlus™ MG assay, 56 percent of M. genitalium positive samples in the study carried a macrolide resistance mutation.⁶ Broad-spectrum antibiotics, including azithromycin therapy, would not have been an effective treatment for these patients.

About PlexPCR™ and ResistancePlus™
PlexPCR™ and ResistancePlus™ are multiplex qPCR kits for detection of infectious diseases and antibiotic resistance markers, respectively. Powered by the company's proprietary PlexZyme™ and PlexPrime™ technologies, both product lines offer high multiplexing capability for better, more streamlined infectious disease management. With increased ability to detect more pathogens as well as multiple genetic markers, every PlexPCR™ and ResistancePlus™ test provides more actionable information for laboratories and clinicians alike.

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. World Health Organization. Sexually transmitted infections (STIs): the importance of a renewed commitment to STI prevention and control in achieving global sexual and reproductive health. Geneva: WHO; 2013.
2. Sonnenberg P. et al. 2015 Epidemiology of Mycoplasma genitalium in British men and women aged 16-44 years: evidence from the third National Survey of Sexual Attitudes and Lifestyles (Natsal-3)In. J. Epidemiol 2015;1-13.
3. Manhart LE. et al 2013. Standard treatment regimens for nongonococcal urethritis have similar but declining cure rates: a randomized controlled trial. Clin Infect Dis 56:934-942.
4. Jensen JS. et al. 2008. Azithromycin Treatment Failure in Mycoplasma genitalium-Positive Patients with Nongonococcal Urethritis Is Associated with Induced Macrolide Resistance. Clin Infect Dis. 2008; 47(12):1546-1553.
5. Jensen, JS. et al 2016. 2016 European Guidelines on Mycoplasma genitalium Infections.
6. Tabrizi, S.N., et al., Multiplex Assay for Simultaneous Detection of Mycoplasma genitalium and Macrolide Resistance Using PlexZyme and PlexPrime Technology. PLOS ONE, 2016. 11(6): p. e0156740.