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
SES Announces Results of the Annual General Meeting2.4.2026 17:49:00 EEST | Press release
SES (the “Company”) held the Annual General Meeting (“AGM”) of Shareholders today in Betzdorf, Luxembourg. Following the recommendations made by the Board of Directors of SES, the shareholders have voted in favor of all resolutions, including the Company’s 2025 annual accounts and the proposed annual dividend of EUR 0.50 per A-share (EUR 0.20 per B-share). The total dividend amount comprises the interim dividend of EUR 0.25 per A-share (EUR 0.10 per B-share), which has already been paid to shareholders on October 16, 2025. The final dividend of EUR 0.25 per A-share (EUR 0.10 per B-share) will be paid to shareholders on April 16, 2026. “I would like to sincerely thank our shareholders for their active engagement, visionary support and continued confidence in SES’ strategy,” said Adel Al-Saleh, CEO of SES. “The outcomes of today’s AGM underscore our shared commitment to a bold multi-orbit approach, with Medium Earth Orbit as the strategic backbone of a dynamically evolving global interco
Forrester: Three Years Into GenAI, Enterprises Are Still Chasing Its True Transformative Value2.4.2026 17:00:00 EEST | Press release
According to Forrester’s (Nasdaq: FORR) latest report, Accelerate Your AI Voyage, most enterprises are struggling to turn growing AI adoption and investment into measurable business impact. One of the key factors holding businesses back is low artificial intelligence quotient (AIQ) — Forrester’s measure of AI aptitude — with many employees lacking a clear understanding of how to use AI. Other barriers include an overemphasis on productivity-focused use cases, difficulty measuring impact, and siloed adoption within individual functions. While these challenges can leave firms frozen in doubt or indecision, the wait-and-see approach to AI adoption is no longer viable. To unlock AI’s full potential, organizations need to focus on four key areas: Define the business outcomes and success metrics for what they want AI to achieve; identify specific use cases for AI deployment aligned to those business outcomes; establish a structured runway to plan, test, and strategically time the deployment
Andersen Consulting Adds Multiplica2.4.2026 16:30:00 EEST | Press release
Andersen Consulting enters into a Collaboration Agreement with Multiplica, a digital consulting firm that helps organizations design, build, and scale impactful digital experiences. Founded in Spain with a presence in Latin America and the U.S., Multiplica focuses on user research and discovery, customer experience research, digital strategy, data modeling and analysis, report automation and data visualization, conversion rate optimization, product design, and user experience design. The firm helps organizations accelerate digital transformation by building digital capabilities, teams, and assets that advance expertise across digital products, consulting, and talent development. Multiplica enables clients to forecast emerging trends in digital experience and transform their businesses through enhanced digital channels and customer engagement. “Collaborating with Andersen Consulting represents an exciting opportunity to extend our reach and impact,” said David Boronat, CEO of Multiplica
Brightfin Unifies Brand Following Proven Optics Merger, Delivering a New Standard for Technology Cost Optimization2.4.2026 16:00:00 EEST | Press release
Brightfin today announced that, following its merger with Proven Optics, the combined company will operate under a single brand: Brightfin. The unified company brings together deep expertise in Technology Expense Management (TEM) and IT Financial Management (ITFM) to help organizations better understand, manage, and reduce total technology spend. Technology spending will exceed $6 Trillion this year, and for most organizations, it remains one of the least understood. CIOs can tell you what they’re spending. Far fewer can tell you whether it’s working. “Over the past several months, we’ve brought these two businesses together around a shared purpose: help enterprise businesses better understand and optimize their technology spend,” said Joel Martins, CEO of Brightfin. “What we are seeing now is a shift. Visibility alone isn’t enough. Teams need to be able to act, tied to real financial outcomes. See Clearly. Spend Better. That is our north star, and that is what our platform is built to
The LYCRA Company Announces Strategic Partnership on Renewable LYCRA ® Fiber2.4.2026 16:00:00 EEST | Press release
The LYCRA Company, a global leader in innovative and sustainable fiber solutions for the apparel and personal care industries, today announced the signing of a strategic partnership agreement with Texhong International Group Limited (“Texhong”), one of the world’s largest suppliers of core-spun cotton textiles. Under the agreement, Texhong will exclusively partner with The LYCRA Company to bring Renewable LYCRA® fiber made with 30 percent plant-based content* to China’s core-spun yarn sector. This collaboration aims to accelerate the adoption of bio-derived spandex across the global apparel and textile industry. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260402505834/en/ The LYCRA Company announced a strategic partnership with Texhong International Group for renewable LYCRA® fiber. Pictured at the signing ceremony held in Shanghai (left to right): Jason Wang, Vice President, Asia, The LYCRA Company, and Zhou Xia, Chief O
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