On-track for De Novo submission after successful meeting with the FDA
SYDNEY, AUSTRALIA--(Marketwired - Jul 24, 2017) - SpeeDx Pty. Ltd., a developer of multiplex molecular diagnostic solutions, is moving forward with their plans for a De Novo submission of their ResistancePlus™ MG test after initial favorable feedback from the FDA. The test will potentially be a first-to-market product in the US, providing detection of the emerging sexually transmitted infection Mycoplasma genitalium (MG) along with genetic markers that confer high level resistance to azithromycin, a common first-line antibiotic treatment.
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 the PlexPCR™ and ResistancePlus™ tests.
MG is more prevalent than Gonorrhea and causes infections such as urethritis, cervicitis and pelvic inflammatory disease, which can lead to serious health complications including infertility.1 The bacteria is rapidly developing resistance to azithromycin, the frontline antibiotic treatment of choice, with recent studies showing up to 50% of MG positive patients harboring resistant strains.2 ResistancePlus™ MG is in high demand across Europe, Australia, and New Zealand, having already gained the necessary regulatory clearances for these markets and is now on-track to commence US clinical trials this year.
“We have developed a much needed tool to support treatment decisions and make a real difference to patient care,” says Colin Denver, SpeeDx CEO. “The advantage of our test lies in the ability to not only determine status of infection, but inform whether the infection could be resistant to frontline treatment, enabling better outcomes for patients with this challenging STI.”
Antibiotic stewardship is a clear priority to maintain current treatment options, as evidenced in the World Health Organization’s most recent essential medicine list.3 Azithromycin has been placed on both an “Access” and “Watch” status indicating a priority for monitoring and stewardship programs. ResistancePlus™ MG is the first test within the SpeeDx ResistancePlus™ pipeline that answers the call for diagnostics that inform patient treatment and supports efforts to maintain effective and appropriate antibiotic prescription.
For more information on Mycoplasma genitalium, ResistancePlus™ MG and SpeeDx, visit: www.plexpcr.com
About MG
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.4 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.2
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.2 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.5 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.
About SpeeDx
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 the creation of 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 Horner PJ et al. 2016 European guideline on the management of non-gonococcal urethritis.
2 Unemo, M. & Jensen, J.S. ‘Antimicrobial-resistant sexually transmitted infections: gonorrhoea and
Mycoplasma genitalium’. 2016. Nat. Rev. Urol.268. Published online 10 Jan 2017. doi:10.1038/nrurol
3 The 2017 Expert Committee on the Selection and Use of Essential Medicines. Found at:
http://www.who.int/medicines/publications/essentialmedicines/en/
4 Centers for Disease Control and Prevention, 2015 Sexually Transmitted Diseases Treatment Guidelines.
5 Jensen, M Cusini, M Gomberg. 2016 European guideline on Mycoplasma genitalium infections.
