SpeeDx Receives CE-IVD Clearance for ResistancePlus MG FleXible
6.9.2019 09:00:00 EEST | Business Wire | Press release
SpeeDx Pty, Ltd. today announced Resistance Plus® MG FleXible for the Cepheid GeneXpert® System, detecting the sexually transmitted infection (STI) Mycoplasma genitalium (Mgen) and markers associated with azithromycin resistance, received CE-IVD mark for sale in Europe. This is the first test to be launched under Cepheid’s FleXible Cartridge programme, partnering with SpeeDx – a trusted assay manufacturer – to provide access to the GeneXpert sample-to-answer FleXible cartridge.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190905006074/en/
ResistancePlus MG FleXible simultaneously detects M. genitalium (Mgen) and macrolide resistance. SpeeDx, a trusted assay manufacturer, has partnered with Cepheid to provide Resistance Guided Therapy for Mgen on the GeneXpert sample-to-answer FleXible cartridge. (Photo: Business Wire)
“ResistancePlus MG FleXible represents both an evolution of our technology and of Resistance Guided Therapy for Mgen”, said Colin Denver SpeeDx CEO. “There is considerable interest by clinicians and laboratories alike, as it will now be even easier to adhere to international and local management guidelines and provide clinically relevant and timely information to manage the growing problem of macrolide resistance in Mgen infections.”
Mgen can cause symptoms such as urethritis, cervicitis, endometritis and pelvic inflammatory disease, and has been linked to reproductive health complications including pre-term birth and infertility.1,2 Macrolide antibiotics, specifically azithromycin, are the first-line treatment for the rapidly growing problem of Mgen, but resistance to these antibiotics has increased up to 50% in several countries.4-6 There are limited alternative treatment options, many of which are expensive, difficult to access, or associated with undesirable side-effects.4,5 Current Mgen guidelines focus on extending the utility of azithromycin by testing for macrolide resistance-associated mutations and stratifying patient treatment accordingly.1-3
“SpeeDx offers unique technology for simultaneous detection of pathogens and drug resistance directly from clinical specimens. Together, we have leveraged the open architecture of our new FleXible cartridge to enable detection of this emerging drug-resistant pathogen on the GeneXpert System,” said David H. Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer. “The ResistancePlus MG Flexible cartridge offers best-in-class performance in an easy to use, on-demand format to address a significant medical need in symptomatic individuals, and adds to the growing portfolio of STI testing options available on our platform.”
Timely detection of antibiotic resistant infections enables Resistance Guided Therapy, resulting in better treatment of the disease for patients, reduced potential for spreading infection among vulnerable populations, and supporting antibiotic stewardship to combat rising antibiotic resistance.
Resistance Plus® MG FleXible will be exclusively distributed by Cepheid.
About SpeeDx
SpeeDx has developed a molecular diagnostics test portfolio, principally for infectious diseases, that provides both identification as well as therapeutic guidance capabilities. The company is based in Australia with offices in Austin and London, and distributors across Europe. SpeeDx specializes in molecular diagnostic solutions that go beyond simple detection to offer comprehensive information for improved patient management. The SpeeDx Resistance Plus® MG open-platform assay is CE marked for sale in Europe, TGA approved for sale in Australia and clinical trials are being finalised for submission to the U.S. FDA. Products in the SpeeDx portfolio focus on multiplex diagnostics for sexually transmitted infection (STI), antibiotic resistance markers, and respiratory disease.
For more information on SpeeDx please see: https://plexpcr.com
- Jensen JS, Cusini M, Gomberg M, Moi H. 2016. 2016 European guideline on Mycoplasma genitalium infections. J Eur Acad Dermatol Venereol. PMID: 27505296.
- https://www.bashhguidelines.org/media/1146/ngu-update-05_2017-final.pdf
- http://www.sti.guidelines.org.au/sexually-transmissible-infections/mycoplasma-genitalium
- Read T R H, Fairley C K, Murray G L, et al. Outcomes of resistance-guided sequential treatment of Mycoplasma genitalium infections: a prospective evaluation, Clinical Infectious Diseases, ciy477, https://doi.org/10.1093/cid/ciy477
- 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.
- Murray GL, Bradshaw CS, Bissessor M, et al. Increasing Macrolide and Fluoroquinolone Resistance in Mycoplasma genitalium. Emerging Infectious Diseases. 2017;23(5):809-812. doi:10.3201/eid2305.161745.
- Miller WC, Ford CA, Morris M, et al. Prevalence of chlamydial and gonococcal infections among young adults in the United States. JAMA 2004; 291:2229–2236.
- 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
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190905006074/en/
Contact information
SpeeDx:
Europe, Australia, New Zealand:
Madeline O’Donoghue
+61 2 9209 4170
madelineo@speedx.com.au
USA:
Rick Roose
+1 415.202.4445
roi.roose@gmail.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Ares Management Prices European Direct Lending CLO II at Over €300 Million19.2.2026 19:25:00 EET | Press release
Ares Management Corporation (NYSE: ARES) (“Ares”), a leading global alternative investment manager, announced today the pricing of its second European Direct Lending Collateralized Loan Obligation, Ares European Direct Lending CLO II (“EDL CLO II”), at over €300 million. Consistent with the underlying composition of its predecessor, EDL CLO II is a diversified CLO comprised entirely of directly originated and actively managed loans issued by over 70 middle-market companies predominantly based in Western Europe and primarily operating in resilient industries. The instrument is weighted towards senior-secured floating rate loans and will be rated by S&P and KBRA. Ares believes EDL CLO II is among the first multi-currency middle-market CLOs in Europe. “We are pleased to successfully price our second European Direct Lending CLO in less than 12 months as we continue building on our nearly 20 years of corporate direct lending experience in Europe,” said Michael Dennis, Partner and Co-Head of
Positive Phase 3 Data Demonstrate Potential for ENTYVIO ® (vedolizumab) to Address Treatment Gap for Children and Adolescents with Moderate to Severe Ulcerative Colitis19.2.2026 19:00:00 EET | Press release
Takeda (TSE:4502/NYSE:TAK) today announced positive data from the pivotal Phase 3 KEPLER trial, which demonstrated that ENTYVIO® (vedolizumab) can offer the possibility of clinical remission for patients ages 2 and older with moderately to severely active ulcerative colitis (UC), a chronic inflammatory disease of the gastrointestinal tract and one of the two most common types of inflammatory bowel disease.1,2 The results, presented at the 21st Congress of the European Crohn’s and Colitis Organisation (ECCO), show vedolizumab’s promising efficacy and safety profile in a patient population where therapy options remain limited.With KEPLER, Takeda is continuing to generate deeper scientific insights and identify additional patient populations who may benefit from vedolizumab, a cornerstone therapy for adults with ulcerative colitis. Vedolizumab is marketed under the trade name ENTYVIO®*. “Ulcerative colitis is a life-altering diagnosis for young patients and their families, often leaving t
Andersen Consulting Broadens Built-Asset Advisory Through Collaboration with Grinity19.2.2026 16:30:00 EET | Press release
Andersen Consulting has entered into a Collaboration Agreement with Grinity, a built-asset consultancy delivering technical, environmental, and sustainable development services to construction and real estate markets. Operating across the Czech Republic and Slovakia with more than 130 professionals, Grinity serves private and public clients in commercial development, industry, technology, automotive, and sustainability. The firm provides multidisciplinary expertise in project and cost management, technical advisory, transactional services, ESG consulting, and energy optimization for buildings. “Sustainability has become a strategic imperative, but clients also need integrated delivery across scope, cost, schedule, risk, and quality,” said Pavel Čermák, CEO of Grinity. “By combining our project and cost management, technical advisory, and energy optimization expertise with Andersen’s global platform, we can deliver comprehensive, forward-looking solutions that drive long-term value for
Fosway 9-Grid™ Analysis Identifies O.C. Tanner as Strategic Leader in the Talent & People Success Market19.2.2026 16:00:00 EET | Press release
O.C. Tanner, the global leader in employee recognition and culture solutions, is honored to be recognized once again as a Strategic Leader in the latest Fosway 9-Grid™ for Talent & People Success. This top industry placement from Fosway Group, Europe’s leading HR and talent analyst, reaffirms O.C. Tanner’s ongoing commitment to innovating employee engagement and workplace culture. Fosway’s independent analysis positions vendors based on performance, potential, market presence, total cost of ownership, and trajectory, helping HR leaders make informed decisions about workplace solutions. O.C. Tanner’s recognition reflects both the strength of its Culture Cloud® platform and its ability to support complex, enterprise-level needs with meaningful outcomes. “Being named a Strategic Leader by Fosway is a powerful validation of the impact our team is delivering for organizations around the world,” said Scott Sperry, President and CEO of O.C. Tanner. “Today’s talent environment demands culture-
Visa Renews Partnership Across Red Bull Formula One Teams19.2.2026 16:00:00 EET | Press release
Visa (NYSE: V) today announced a multi‑year renewal and expansion of its global partnership with Red Bull F1 Team’s Oracle Red Bull Racing and Visa Cash App Racing Bulls. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260219542270/en/ Building on the groundbreaking partnership launched in 2024, the renewed agreement reinforces Visa’s commitment to one of the world’s fastest‑growing sports, while introducing significant new branding rights, enhanced hospitality assets and immersive experiential opportunities across both teams. Visa will also continue as a Title Partner of both Visa Cash App Racing Bulls Formula One Team and its F1 Academy Programme, further strengthening Visa’s presence on and off the grid. “This renewal reflects the extraordinary momentum we’ve built with Red Bull Racing Teams, Visa Cash App Racing Bulls and Oracle Red Bull Racing, and our shared ambition to push what’s possible at the intersection of sport,
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom