Subsidiary prepares for expected 2018 US product launch
SYDNEY, Australia, Dec. 04, 2017 (GLOBE NEWSWIRE) — SpeeDx Pty. Ltd, a developer of advanced multiplex molecular diagnostic solutions, announced the incorporation of a US-based subsidiary company, SpeeDx Inc. The parent company, headquartered in Australia, will use the US base to support current clinical trial activity for ResistancePlus™ MG (not currently for sale in the US), in preparation for an expected 2018 launch. The SpeeDx ResistancePlus™ MG test detects the sexually transmitted bacteria Mycoplasma genitalium along with mutations that confer resistance to azithromycin, the front-line antibiotic treatment of choice.
ResistancePlus™ MG will potentially be a first-to-market molecular diagnostic test in the US, providing both detection of the MG infection along with information about antibiotic resistance of the disease. The test previously received regulatory clearances in Europe, Australia and New Zealand and is already experiencing strong sales in those locations. SpeeDx recently signed a partnership agreement with Thermo-Fisher to help bring the ResistancePlus™ MG test to the US and a distribution agreement with Cepheid in Europe for their PlexPCR™ and ResistancePlus™ tests.
“We have always had the goal of bringing ResistancePlus MG to the US market”, said Colin Denver, CEO of SpeeDx, “local offices and staff will allow us to more easily navigate the FDA approval process and keep us on track for our product launch next year.”
A rapid rise in resistant strains of M. genitalium across the globe has led to international guidelines for the management of M. genitalium infections that recommend testing for macrolide resistance to better inform treatment options.1 With M. genitalium prevalence rapidly increasing in the US, and in some instances exceeding that of Chlamydia,2 it is expected that US guidelines will also be updated to address antimicrobial resistance in this significant sexually transmitted disease (STD).
“Our aim is to empower clinicians and physicians to make the best treatment decisions about the diseases they are faced with,” said Colin Denver. “Ultimately, we want to support individualised patient management and better antimicrobial stewardship, which will help patients quickly receive the best treatment for their disease and for physicians to better address antibiotic resistance challenges.”
Mycoplasma genitalium can cause symptoms such as urethritis, cervicitis, endometritis and pelvic inflammatory disease. In recent studies, it has been found to have a higher prevalence than Gonorrhea.3 Like Gonorrhea, MG is also evolving into a so-called STI “superbug” that is becoming resistant to many antibiotic treatments, leading to exceedingly difficult-to-treat infections and threatening global public health.4
Macrolide antibiotics, specifically azithromycin, are the first-line treatment for M. genitalium infections, but resistance to these antibiotics has increased up to 50 percent in several countries.4 New European Guidelines for the treatment of M. genitalium infections were released last year recommending the molecular detection of M. genitalium with an assay capable of detecting macrolide resistance-associated mutations.1 Timely detection of antibiotic resistant infections enables better treatment of the disease, lessens the potential for spreading among vulnerable populations and combats the rising level of antibiotic resistance.
Currently, there is not a commercially available, FDA-cleared molecular diagnostic test for the detection of MG.
Founded in 2009, SpeeDx is an Australian-based private company with offices in London and distributors across Europe. SpeeDx specializes in molecular diagnostic solutions that go beyond simple detection to offer comprehensive information for improved patient management. Innovative real-time polymerase chain reaction (qPCR) technology has driven market-leading multiplex detection and priming strategies. Product portfolios focus on multiplex diagnostics for sexually transmitted infection (STI), antibiotic resistance markers, and respiratory disease. Currently, SpeeDx markets the only CE-marked and TGA approved commercial molecular test for the STI M. genitalium (ResistancePlus™ MG) that combines detection of the disease with detection of markers for antibiotic resistance. For more information about SpeeDx please see: http://www.plexpcr.com
1 Jensen, JS. et al 2016. 2016 European Guidelines on Mycoplasma genitalium Infections.
2 Getman D et al. Mycoplasma genitalium prevalence, coinfection, and macrolide antibiotic resistance frequency in a
multicenter clinical study cohort in the United States. J ClinMicrobiol 2016; 54:2278–2283.
3 Centers for Disease Control and Prevention, 2015 Sexually Transmitted Diseases Treatment Guidelines.
4 Unemo, M & Jensen, JS. Antimicrobial-resistant sexually transmitted infections: gonorrhoea and Mycoplasma genitalium. 2016. Nat. Rev. Urol. 268. Published online 10 Jan 2017. doi:10.1038/nrurol
Contacts for SpeeDx:
+61 2 8212 8512 (ext 008)