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
Bolstering its Executive Team, Taktile Welcomes Engineering Powerhouse James Broadhead as CTO16.9.2026 12:00:00 EEST | Press release
Taktile, the leader in AI transformation for financial institutions, today announced it has hired engineering veteran James Broadhead as its chief technology officer. Broadhead, who is based in Dublin, Ireland, most recently worked at Databricks and brings nearly 15 years of experience in software engineering and development, including at X (Twitter), Neon and MongoDB. At Neon, Broadhead led engineering through exponential growth of the platform driven by Agentic software development, more than tripling company revenue before its acquisition by Databricks. “Taktile is growing rapidly across global markets, and James’ leadership will be instrumental as we expand our R&D function and global footprint,” said Taktile CEO and co-founder Maik Taro Wehmeyer. “James’ extensive background and expertise in engineering will take Taktile to the next level in powering mission-critical financial decisions at scale with AI.” Alongside this appointment, Taktile co-founder and current chief product and
Vantor, UK Ministry of Defence and Industry Partners Establish Defence Intelligence Innovation Cluster – Project FAIRFAX16.9.2026 11:00:00 EEST | Press release
Vantor, the leader in unified spatial intelligence, announced today it has joined the UK Ministry of Defence and industry partners to launch the UK Defence Intelligence Innovation Cluster, a new collaboration designed to accelerate the development and deployment of next-generation defence and intelligence capabilities and strengthen the UK’s sovereign defence industrial base. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260916244808/en/ Vantor's Mike Buckley with RAF Wyton officials, council and industry partners at the FAIRFAX Collaboration Hub opening. The cluster is being established through Project FAIRFAX, a joint initiative between the UK Ministry of Defence, Huntingdonshire District Council, Vantor, CGI UK and MAIAR. Together, the founding partners are creating a permanent hub at RAF Wyton where the UK government, industry and academia can work together on operational challenges, evaluate emerging technologies and a
More than Half of Consumers are Comfortable with AI Agents Applying for Credit, Experian Research Finds16.9.2026 11:00:00 EEST | Press release
Consumers are ready to take the next step in their relationship with artificial intelligence (AI), according to AI in Risk: The Rise of Agentic Commerce, new research from data and technology company, Experian, conducted by Forrester Consulting. The study of 6,247 credit-active consumers across 13 EMEA and Asia Pacific markets, found that more than half (54%) of respondents are comfortable with AI agents applying for credit on their behalf. The findings point to the next stage in the evolution of financial services, where consumers are becoming comfortable allowing AI to move beyond providing information to supporting parts of the lending journey, including comparing lenders, checking eligibility, completing applications and securely submitting authorised documents. "Consumers are already changing the way they engage with financial services," said Mariana Pinheiro, Chief Executive Officer, Experian EMEA & Asia Pacific. "They are not just experimenting with AI anymore; they are beginnin
Aqara Announces the Availability of The Spatial Multi-Sensor FP400, Offering Advanced Spatial Intelligence for Smart Homes16.9.2026 10:00:00 EEST | Press release
Aqara, a global leader and pioneer in IoT, today announced the release of the Spatial Multi-Sensor FP400. The FP400 is designed to bring precise, spatial intelligence to homes without sacrificing the privacy typically compromised by smart cameras. Rather than simply detecting motion or presence, the FP400 enables homes to better understand occupancy, movement, and context for more granular and personalized automations and insight. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260916958372/en/ Aqara Announces the Availability of The Spatial Multi-Sensor FP400, Offering Advanced Spatial Intelligence for Smart Homes The Spatial Multi-Sensor FP400 redefines how smart homes perceive and interact with living spaces by combining high-precision spatial sensing with AI-powered environmental understanding. Powered by a next-generation high-precision 60GHz mmWave radar, the FP400 delivers industry-leading multi-person sensing, precise
Cambridge Associates Opens Italian Office and Expands European Leadership16.9.2026 10:00:00 EEST | Press release
Global investment firm Cambridge Associates (CA) today announced the opening of a new office in Milan and the appointment of two senior hires in Europe. The move reflects the firm’s ongoing commitment to providing bespoke services to current and future institutional and family office investors across the region. Raphael Heynold has joined the Client Solutions team as Head of EMEA and APAC and will serve on the firm’s EMEA Operating Committee. Based in London, Raphael is a key member of the Global Client Solutions Leadership team, responsible for driving growth and market expansion and overseeing client engagement efforts across Europe, the Middle East, and Asia Pacific regions. Heynold brings more than 30 years of experience across client strategy, investment banking and investment management, and has worked with many sophisticated families and institutions around the world. Riccardo Pianeti has joined Cambridge Associates to lead the Italian office. He will serve as Head of the Milan
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