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
Meiji Seika Pharma: Positive Results from the Phase III Integral-1 Trial of Nacubactam, a Novel β-Lactamase Inhibitor, in Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis ― Published in The Lancet15.5.2026 04:00:00 EEST | Press release
Meiji Seika Pharma Co., Ltd. (headquartered in Tokyo; President and Representative Director: Toshiaki Nagasato) today announced that the results of the Integral-1 study, one of two global Phase III clinical trials evaluating the efficacy and safety of its novel β-lactamase inhibitor nacubactam (development code: OP0595), have been published in The Lancet. The article is entitled “---Efficacy and safety of cefepime–nacubactam and aztreonam–nacubactam compared with imipenem–cilastatin for complicated urinary tract infection or acute uncomplicated pyelonephritis (Integral-1): a double-blind, randomised phase 3 trial” (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)00596-9/fulltext) Integral-1 is a global, double-blind, randomized Phase III trial (jRCT2031230075) in patients with complicated urinary tract infection or acute uncomplicated pyelonephritis that compared the efficacy and safety of nacubactam co-administered with either cefepime or aztreonam versus imipenem-c
Xsolla and Skich Announce Strategic Partnership to Bring Merchant of Record Payments to an Alternative Mobile Game Marketplace14.5.2026 19:00:00 EEST | Press release
Xsolla, a leading global video game commerce company, today announced a strategic partnership with Skich, an alternative mobile game marketplace operating on iOS in the EU under Apple's Digital Markets Act provisions and on Android globally. Under the agreement, Xsolla will serve as Merchant of Record for in-app purchases and paid game sales distributed through the Skich Store. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260514867730/en/ Graphic: Xsolla Skich serves as an alternative to traditional mobile storefronts, offering developers a way to reach players outside platform-controlled distribution channels. The partnership with Xsolla enables Skich to offer a fully compliant payment and commerce layer, with Xsolla managing payment processing, tax collection, refunds, and regulatory compliance on behalf of developers, removing a significant operational and legal barrier for studios looking to distribute through alternat
Boomi Teams up With Gong to Bring Revenue AI to Boomi Agentstudio14.5.2026 19:00:00 EEST | Press release
Boomi, the data activation company for AI, today announced a collaboration withGong, the leader in Revenue AI, to bring revenue signals captured in Gong natively into the Boomi Enterprise Platform. This collaboration enables enterprises to establish an active data foundation designed to transform customer conversations into coordinated, automated actions across systems and functions enterprise-wide with Boomi Agentstudio. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260514443012/en/ Boomi Teams Up with Gong to Bring Revenue AI to Boomi Agentstudio Gong goes beyond capturing deal activity to surface real-time insights into risk, buyer intent, competitive dynamics, and key engagement signals. That intelligence moves from conversation to coordinated action, flowing across CRM, ERP, product, and operational systems with the governance and security that enterprises require. Through this collaboration, these signals can be serve
Boomi and Guru Partner to Deliver AI-Powered Enterprise Knowledge Enriched by Real-Time Data Activation14.5.2026 17:30:00 EEST | Press release
Boomi, the data activation company for AI, and Guru, the AI-powered enterprise knowledge platform, today announced a technology partnership to help organizations unlock the full value of their enterprise data for AI-driven decision-making. Unveiled at Boomi World 2026, the partnership makes Guru a launch partner for Boomi Connect, Boomi’s new managed connector service, and integrates Guru’s knowledge agents with Agentstudio and the Boomi MCP Registry to deliver richer, more accurate, and more actionable insights to knowledge workers and AI agents alike. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260514440755/en/ Guru was selected as a Boomi Connect launch partner because its AI-powered knowledge platform represents one of the highest-value consumption patterns for managed enterprise connectivity. Knowledge agents are only as effective as the data they can access, and Guru’s ability to synthesize insights across enterpris
IQM and Real Asset Acquisition Corp. Announce Public Filing of Form F-4 Registration Statement with the SEC14.5.2026 16:55:00 EEST | Press release
IQM Finland Oy, a global leader in full-stack superconducting quantum computers (“IQM”, “IQM Quantum Computers” or the “Company”), and Real Asset Acquisition Corp. (Nasdaq: RAAQ), a special purpose acquisition company (“RAAQ”), announced today the public filing of a registration statement on Form F-4 (the “Registration Statement”), which includes a preliminary proxy statement, with the U.S. Securities and Exchange Commission (“SEC”) in connection with the proposed Business Combination Agreement announced February 23, 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260514989293/en/ IQM Radiance quantum computer Jan Goetz, Chief Executive Officer and Co-Founder, IQM, said: “This filing is a milestone we have worked hard to reach, and it signals our readiness to operate at a new level. Public markets will give IQM the platform and capital to accelerate everything we are building as we work towards delivering fault-toleranc
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