SYDNEY, AUSTRALIA -- (Marketwired) -- 06/08/17 -- SpeeDx Pty, Ltd., a developer of innovative molecular diagnostic solutions, today announced an agreement with Cepheid for distribution of its PlexPCR™ and ResistancePlus™ molecular diagnostic products in key markets throughout Europe. The agreement, covering Germany, France, Italy, and the UK, will increase coverage for the market-leading ResistancePlus MG test, the first CE-IVD test for the sexually transmitted infection (STI) Mycoplasma genitalium (MG) to combine detection with testing for azithromycin resistance.
The timing of the agreement coincides with recent guideline changes across Europe recommending MG resistance screening in the management of non-gonococcal urethritis.(1) The inclusion of a macrolide resistance test when detecting M. genitalium provides clinicians with much needed information to guide antibiotic treatment. MG is more prevalent than Gonorrhea and its resistance to frontline macrolide antibiotic treatment is rapidly increasing and has been observed in up to 50 % of M. genitalium positive patients in recent studies.(2)
"This partnership is a true win-win," said Colin Denver, CEO of SpeeDx. "We gain better access to these important European markets and Cepheid can bring its customers a comprehensive test for M. genitalium and azithromycin resistance."
"SpeeDx offers a unique approach to simultaneous detection of pathogens and drug resistance directly from clinical specimens, consistent with Cepheid's approach to detecting tuberculosis," said David H. Persing, MD, Ph.D., Cepheid's Chief Medical and Technology Officer. "This technology could potentially be applied in multiple settings in which actionable treatment information is needed quickly."
M. 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. Like Gonorrhea, M. genitalium 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.
Macrolide antibiotics, specifically azithromycin, are the first-line treatment for the rapidly growing problem of M. genitalium STIs, but resistance to these antibiotics has increased up to 50 percent in several countries. This development led authors of the 2016 European guideline on Mycoplasma genitalium infections to recommend complementing the molecular detection of M. genitalium with an assay capable of detecting macrolide resistance-associated mutations.
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 on about SpeeDx please see: http://www.speedx.com.au
Based in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit www.cepheid.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
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Contacts for SpeeDx:
Sarah Khan, PhD
SeedMedia Pty Ltd.
Contact for Cepheid:
Tel. + 1.408.400.4324