SpeeDx Receives CE-IVD Clearance for ResistancePlus MG FleXible
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
United First Partners Serves as Introducing Broker on Mayflower IPO, a UK Listed Acquisition Vehicle and Among the Largest Primary New Issues in London in 2025, Highlighting UFP’s Increasing Presence Across ECM10.12.2025 19:42:00 EET | Press release
United First Partners (“UFP”) is pleased to announce its role as Introducing Broker on Mayflower Acquisition Limited (“Mayflower”), which completed its IPO today, raising USD 500 million. The size of the capital raised places Mayflower among the largest London acquisition vehicles of recent years. The offering represents an important development for UFP’s expanding capital markets platform and reflects the firm’s increasing activity within Equity Capital Markets (ECM). About Mayflower Acquisition Limited Mayflower is a UK Listed Acquisition Vehicle, sponsored by TOMS Capital and JRJ Group, incorporated to unlock exits across a closely-held company universe, including long-held private equity assets and large family-owned businesses. Mayflower’s structure provides guaranteed capital to asset owners, offering a flexible liquidity solution and higher potential for transaction success, and highly aligned economics to investors, with a significant Sponsor commitment of USD 75m. Mayflower wa
Abu Dhabi Launches FIDA Cluster to Shape the Next Generation of Financial and Investment Solutions10.12.2025 19:21:00 EET | Press release
Abu Dhabi has launched the FinTech, Insurance, Digital and Alternative Assets (FIDA) cluster to accelerate the development of next-generation financial and investment solutions and expand the emirate’s role as a global capital hub. Spearheaded by the Abu Dhabi Department of Economic Development (ADDED) and the Abu Dhabi Investment Office (ADIO), the cluster is a core pillar of Abu Dhabi’s long-term economic diversification agenda. By 2045, FIDA is projected to contribute an additional USD 15.2 billion to Abu Dhabi’s direct GDP, generate 8,000 skilled jobs and attract at least USD 4.6 billion in investment, cementing the emirate’s position as a destination for innovative and resilient financial systems. FIDA brings together high-growth areas where technology, regulation and capital intersect, including fintech, digital assets, insurance, reinsurance and alternative investments. It aims to position Abu Dhabi as a preferred jurisdiction for global firms seeking to design, test and scale n
Xsolla Celebrates a Week of Industry Programming at The Game Awards With a New Brand Launch, Day of the Devs Participation, and GamesBeat Hollywood & Games 2025 Partnership10.12.2025 19:00:00 EET | Press release
Xsolla, a leading global video game commerce company that helps developers launch, grow, and monetize their games, today announced a unified lineup of programming during The Game Awards week in Los Angeles. Together, these initiatives showcase Xsolla’s commitment to bringing the community and ecosystem together to support creators, strengthen the relationship between games and their players, and enable games to reach more markets around the world. The week of activities includes its partnership with GamesBeat Hollywood & Games 2025, a featured role during Day of the Devs: The Game Awards Digital Showcase, Games for Love’s The Game Gala, and the unveiling of Xsolla’s refreshed brand identity. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251210688609/en/ Berkley Egenes – Chief Marketing & Growth Officer at Xsolla The brand refresh is the centerpiece of Xsolla’s presence throughout the week, reflecting Xsolla’s future-forward
Hanseo University Expands Aviation Training Program with New Frasca Flight Training Device10.12.2025 17:05:00 EET | Press release
Frasca International, Inc., a FlightSafety International company and leader in flight simulation, today announced that Hanseo University in South Korea is expanding its aviation program with a new Level 5 Cessna 172 Flight Training Device (FTD), the seventh Frasca device to join the university’s fleet. Hanseo University’s school of Aeronautical Science recognized by the Korean University Accreditation Institute as the nation’s first Specialized University for Training Professional Workforce Industries, continues to expand its state-of-the-art simulation capabilities with the acquisition of a Level 5 Cessna 172 FTD. The addition builds on a partnership with Frasca that has spanned more than two decades and further advances aviation education across Asia. “We were seeking simulators that provided both realism and reliability, and Frasca stood out immediately,” said Dr. HanSuk Jung, Vice President Aeronautics, Hanseo University. “Over the years, our partnership has become a deep and lasti
Bregal Milestone Announces Majority Growth Investment in Beyond Now10.12.2025 17:00:00 EET | Press release
Bregal Milestone, a leading European software growth private equity firm, today announced a majority growth investment in Beyond Now (the “Company”), a fast-growing, cloud-native supply chain software provider for AI-enabled digital commerce. Driven by strong customer demand, Beyond Now has generated profitable growth and >40% last twelve-month ARR growth. Beyond Now supports some of the world’s largest and most innovative Communication Service Providers (CSPs), including Verizon, AT&T, Deutsche Telekom, and NTT, in managing complex digital supply chains to create seamless end-to-end partner and customer operations. Founded in 2018, the Company serves telecommunication providers, technology companies, and private enterprises to efficiently scale and monetize digital services through its suite of modern, Ecosystem Orchestration and Digital Platforms - including an AI Digital Business Platform for orchestrating partner offerings, an AI Digital Marketplace solution for personalized custom
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