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
OPEX® Corporation Offers a Simplified, One-Touch Document Scanning Solution with the Introduction of Axis™6.10.2026 11:00:00 EEST | Press release
OPEX® Corporation, a global leader in Next Generation Automation providing innovative solutions for warehouse, document and mail automation, has announced the launch of Axis™, a new document scanner that brings the benefits of one-touch scanning to a simplified, single-bin configuration. Designed for document capture workflows where minimal document preparation, mixed media handling or operational simplicity are priorities, Axis bridges the gap between OPEX’s desktop scanner series and its multi-bin production scanner portfolio. “We developed Axis in direct response to market demands,” said Dann Worrell, President, Document and Mail Automation, OPEX. “Our customers want to simplify their scanning processes, reduce operating costs, and improve quality. Axis delivers on these priorities by combining our minimal-prep, One-Touch scanning technology with a single-bin design. With a lower market accessible entry point, Axis helps customers process documents more efficiently while achieving m
Rothera Goes Live on Smartstream’s Air to Automate High-Volume Derivatives Reconciliations6.10.2026 11:00:00 EEST | Press release
Smartstream, the trusted data solutions provider for leading global financial institutions and enterprises, today announced that Rothera, the U.S.-based CFTC-regulated event contract market, has gone live on Smartstream’s Air. Rothera has deployed Smartstream’s Cash and Data modules to automate high-volume derivatives reconciliations across its CFTC-regulated exchange and clearinghouse business. As transaction volumes on the exchange grew, Rothera sought to scale and automate its existing reconciliation processes to support greater operational efficiency and robust audit controls. To support this growth, Rothera selected Air’s Cash and Data modules as a new implementation. The AI-powered platform ingests, matches, and reconciles high-volume data flows with minimal manual intervention, providing a fully audited environment aligned with regulatory obligations of a CFTC-regulated venue. Following an initial go-live for two data reconciliations: Exchange-to-Clearing Instruments and Exchang
Convatec Survey Challenges Assumptions About Leakage in Ostomy Care6.10.2026 10:00:00 EEST | Press release
Convatec, a leading medical products and technologies company focused on solutions for the management of chronic conditions, today released Rethinking leakage in ostomy care, new international research highlighting a significant gap in how peristomal skin health is understood and managed in ostomy care. The findings indicate that skin health plays a critical role in preventing leakage, and supporting confidence in daily life, yet remains widely under-recognised in routine care. For many people, leakage is not only a clinical or product issue; it can shape whether they feel able to travel, exercise, socialise or take part fully in everyday life. More than half of respondents said they avoid such activities due to worry about their ostomy. The results of the survey, which included more than 1,800 people living with an ostomy and over 400 healthcare professionals, point to a significant opportunity to improve outcomes through greater focus on peristomal skin health, the specific area of s
Oulu2026 Boosts Tourism as Björk, Art and Technology Lead the European Capital of Culture Year’s Finale6.10.2026 10:00:00 EEST | Press release
The Oulu2026 European Capital of Culture programme has attracted visitors to northern Finland and contributed to strong tourism growth. According to Visit Oulu statistics, Oulu recorded nearly 475,000 registered overnight stays between January and August 2026, an increase of 12 per cent year on year. International overnight stays rose by 21 per cent to more than 96,600, while domestic overnight stays increased by 9 per cent. The trend continued in August, when international overnight stays grew by almost 29 per cent year on year. Hundreds of events combining art, technology, science, music, theatre and sport continue throughout the final months of 2026. “The programme’s diversity is clearest in the final months. There is something for culture enthusiasts and families alike, with experiences that cannot be found anywhere else. If ever there was a time to visit Oulu, it is now,” says Samu Forsblom, Programme Director of Oulu2026. A major highlight is the Lumo Art & Tech Festival, taking
Ant International and HSBC Expand Real-Time Treasury Management Services to the Middle East6.10.2026 09:30:00 EEST | Press release
Ant International today announced an expanded collaboration with HSBC to enhance real-time treasury management services in the Middle East. By leveraging HSBC’s global Tokenised Deposit Service (TDS), Ant International aims to improve the efficiency of its treasury operations across the region. As part of the collaboration, Ant International has successfully completed pilot transactions across two payment corridors connecting the United Arab Emirates and Hong Kong: Intra-UAE dirham transfers: Real-time, dirham-denominated tokenised deposit transactions within the UAE. Cross-border US dollar payments initiated from the UAE: US dollar-denominated tokenised deposit transfers between the UAE and international markets, including Hong Kong and Singapore. These transactions were initiated via WhaleRTP – Ant International’s proprietary, blockchain-based real-time treasury management platform – and executed in real-time through HSBC’s TDS. Ant International and HSBC jointly designed the transac
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