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
Crimson Moon Releasing September 1 for $19.99 USD, Offering This Fall’s Best Value for a Hellish Action RPG, Solo or With a Friend4.8.2026 20:00:00 EEST | Press release
ProbablyMonsters, an independent video game company focused on building original IP, today announced that Crimson Moon will release September 1, 2026, on PC via Steam and the Epic Games Store, PlayStation 5, and Xbox Series X|S for $19.99 USD, offering a focused game that delivers high-quality visuals and gameplay at an accessible price point. The company also revealed that famous metal musicians HEALTH, Jared Dines, Misha Mansoor, and Ricky Armellino will be composing original songs for the game’s boss encounters. The details were confirmed in a newly-released gameplay trailer, which also announced a Deluxe Edition of Crimson Moon that will cost $29.99 USD on all platforms, offering players access to the Ceremonial Armor Set and the Axe of the Gods weapon cosmetic, along with an upcoming expansion for Crimson Moon that will be released at a later date. “We’ve made Crimson Moon an intense action-adventure RPG that’s approachable to players. We want as many people as possible to enjoy i
Frontgrade Expands Executive Team as Demand Grows for Mission-Ready Space and Defense Technologies4.8.2026 18:48:00 EEST | Press release
Frontgrade Technologies Inc. (“Frontgrade”), a leading provider of mission-critical electronics and subsystems, today announced the expansion of its executive leadership team as it continues to invest in the capabilities for the next generation of space, defense, and intelligence missions. Spanning finance, information technology, operations, reputation, go-to-market, and product leadership, the appointments reinforce Frontgrade's commitment to accelerating innovation and helping customers navigate an increasingly complex environment. The six appointments include: Andrew Matsuyama, Chief Financial Officer, brings more than 30 years of finance and business leadership experience during periods of growth and transformation in industrial and technology driven organizations. Most recently he served as CFO for Honeywell Sundyne. Leveraging this experience, Matsuyama will advance Frontgrade’s financial strategy, strengthen its operating foundation, and support continued focus on customers and
Growing with Purpose, Delivering with Impact: ProAmpac Releases 2026 Sustainability Impact Report4.8.2026 18:13:00 EEST | Press release
ProAmpac, a global leader in flexible packaging and material science, announces the release of its 2026 Sustainability Impact Report, centered around the theme Growing with Purpose, Delivering with Impact, the report highlights the company's advancements in sustainable innovation, environmental stewardship, employee safety, and responsible business practices while expanding its global footprint. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260804969765/en/ ProAmpac's 2026 Impact Report is here Reflecting another year of meaningful achievements, the report demonstrates how ProAmpac is embedding sustainability throughout its business, from advancing innovative packaging solutions and reducing environmental impacts to strengthening workplace safety and supporting the communities where employees live and work. Notable achievements highlighted in the 2026 Sustainability Impact Report include: Continued Global Growth: Expanded P
New Esri Press Book Empowers Users to Unlock the Potential of AI with the Power of Geography4.8.2026 17:35:00 EEST | Press release
Esri has released Exploring GeoAI: Tools and Workflows, a practical guide to applying geospatial artificial intelligence (GeoAI) using ArcGIS. Designed for GIS professionals, analysts, and data scientists, this hands-on workbook provides the knowledge and tools needed to integrate advanced AI workflows into real-world spatial analysis. As GeoAI continues to transform how organizations analyze and interpret location-based data, Exploring GeoAI equips readers with the skills to confidently implement deep learning models and workflows. The book guides users through the full GeoAI life cycle—from preparing systems and data to training, evaluating, and deploying models in operational environments. Readers begin by learning how to install and configure deep learning frameworks, assess hardware capabilities, and optimize system performance. From there, they progress through key stages of the GeoAI workflow, including defining project requirements, selecting appropriate data, choosing and trai
Rehlko Defines What It Takes to Build AI-Ready Power Infrastructure as Data Center Energy Demands Evolve4.8.2026 16:15:00 EEST | Press release
Rehlko, a global industrial energy resilience platform providing custom-engineered, integrated power solutions for mission-critical infrastructure worldwide, today released new insights on the power infrastructure requirements emerging from the rapid growth of large language models and artificial intelligence. In its latest eBook, AI Readiness Starts with Power: Designing for Real-World Load Conditions, Rehlko examines how increasingly dynamic AI workloads are reshaping expectations for data center power systems and highlights key infrastructure considerations for operators seeking to scale AI capacity reliably and efficiently. As the eBook outlines, AI readiness is increasingly defined not by installed capacity, but by how systems perform under highly variable real-world load conditions. The AI Power Challenge As investment in AI infrastructure accelerates, data center operators face growing pressure to deploy capacity faster than traditional utility infrastructure can support. At the
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