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
LTM Introduces BlueVerse™ Currency to Enable Outcome-Based Pricing in the Agentic AI Era10.6.2026 11:30:00 EEST | Press release
LTM, the Business Creativity partner to the world’s largest enterprises, today introduced BlueVerse™ Currency, an AI-linked commercial model that prices enterprise work by outcomes rather than effort consumed as enterprises scale agentic AI across core processes. BlueVerse Currency brings together the full BlueVerse stack—People (expertise on demand), Accelerators (reusable assets that speed delivery), Agents (autonomous AI workforce), Platforms (orchestration layer to scale delivery), and Tokens (compute and model usage)—into a single commercial construct. It introduces outcome-linked pricing tied to measurable business results, enabling shared productivity gains so clients can capture AI-driven efficiency value. The model also supports fungible resourcing, enabling reallocation mid-contract to evolving priorities, and faster reinvestment, with savings redirected into innovation. It is underpinned by a hybrid structure with fixed and variable pricing components, supported by use-case–
Smead Capital Management Extends International Value Strategy to Global Investors Through New Fund10.6.2026 10:00:00 EEST | Press release
Smead Capital Management, a Phoenix-based investment management firm and a leader in value investing, today announced the launch of the Smead Global ex-US Value UCITS Fund designed to provide global investors with access to a product modeled after the firm’s long-standing Smead International Value Strategy. The Smead Global ex-US Value UCITS Fund is domiciled in Luxembourg. Investors can access the fund through Smead Capital Management’s website and it is available to professional and qualified investors through the fund’s transfer agent. The strategy that the Smead Global ex-US Value UCITS Fund is modeled after, the Smead International Value Strategy, has been a core contributor to Smead Capital Management’s outstanding performance for over a decade. Like all Smead products, the Global ex-US Value UCITS Fund will be built on Smead’s eight investment criteria and a disciplined, contrarian, value approach. “Many investors around the world believe non-US companies cannot produce attracti
Dodge Opens Orders for the Next Generation Charger in Europe10.6.2026 10:00:00 EEST | Press release
An Icon Enters Its Next Generation This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260609386800/en/ Celebrating its 60th anniversary this year, Dodge opens a bold new chapter in Europe with the launch of the next-generation Dodge Charger, bringing one of America’s most iconic muscle cars back to European roads through a new multi-energy lineup engineered to deliver performance and attitude without compromise. Six decades after the original Charger helped define the muscle car era, this new eighth-generation model evolves the formula for a new generation of drivers while remaining unmistakably Dodge in character, design and presence. Available with both all-electric and gasoline powertrains, the new Charger reflects Dodge’s performance-first philosophy: different powertrains, same muscle car DNA. The next-generation Charger arrives in Europe in both two-door and four-door configurations, combining iconic proportions, wide-body
Roquette Showcases Scalable Drug Delivery Innovations at CPHI China 202610.6.2026 10:00:00 EEST | Press release
Roquette, a global leader in plant-based ingredients and pharmaceutical excipients, will showcase its comprehensive portfolio of innovative drug delivery solutions at CPHI & PMEC China 2026, taking place June 16-18 at the Shanghai New International Expo Centre (SNIEC). Under the theme “One Roquette for Innovations,” Roquette’s Health & Pharma Solutions Business Unit will exhibit at booth E3D26, highlighting how its deep scientific expertise and technical capabilities enable pharmaceutical companies to turn promising formulations into scalable commercial realities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260610596225/en/ Visit Roquette at booth E3D26 to meet with its team of experts “As the pharmaceutical industry accelerates innovation, from GLP-1 therapies to complex biologics, the pressure to deliver manufacturing reliability, consistent supply, and robust formulations at scale has never been greater,” said Angela S
Trustd Brings Know Your Carrier to Market as Freight Fraud Costs European Supply Chains Over €1bn10.6.2026 09:01:00 EEST | Press release
Trustd, the digital identity and credentials verification platform for transport and logistics, is bringing to market Know Your Carrier (KYC), a web-based verification tool that lets shippers and 3PLs get an instant risk signal on carriers quoting for work via email in seconds. Cargo crime across EMEA has risen 438% in three years. More than 108,000 supply chain thefts were recorded across the region in the last two years. Of the 5% that reported a financial loss, the combined value exceeded €1bn, equivalent to €1.3m every 24 hours. Know Your Carrier draws on Trustd's expertise in digital identity verification to address a problem that has until now had no industry-wide solution. The web-based tool plugs into existing workflows with no installation or integration. Users enter an email address and, where available, a VAT number. The tool checks email legitimacy and domain matching, business registration data, adverse media, sanctions and court judgments, and Trustd’s own growing network
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