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
2PointZero Group Completes Majority Acquisition in Italy-Based ISEM Packaging Group for AED 704 Million5.3.2026 23:02:00 EET | Press release
2PointZero Group PJSC (ADX: 2PointZero), a next-generation investment powerhouse focused on energy and consumer sectors, announced today that it has formally completed the transaction to acquire a majority position in ISEM, a leading European packaging group serving beauty, fashion, luxury, nutraceuticals and more, for AED 704 million through a combination of secondary and primary capital earmarked to accelerate organic and inorganic growth. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260305800523/en/ 2PointZero Group completes majority acquisition in Italy-based ISEM Packaging Group for AED 704 million (Photo: AETOSWire) 2PointZero Group now holds 60.8% of ISEM, while Peninsula Capital and minority investors own the remaining 39.2%. This marks the start of a strategic partnership between 2PointZero and Peninsula. Together, the partners will reinforce ISEM’s leadership position with a focus on category and geographic expa
Xsolla Announces Reseller Program to Help Game Developers Unlock New Revenue Streams in Local Markets5.3.2026 19:00:00 EET | Press release
Xsolla, a leading global video game commerce company, today announced the Xsolla Reseller Program, a new product designed to help game developers scale and capture untapped revenue in local markets with no development needed. The program launches with a curated cohort of resellers and distributors in Southeast Asia and Latin America, with expansion into additional regions throughout 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260305047070/en/ Graphic: Xsolla As game developers pursue global growth, they face a fundamental infrastructure challenge: billions of dollars in revenue remain untapped in emerging, cash-dependent economies, such as Southeast Asia, Latin America, the Middle East, and North Africa, where players purchase digital content through local distribution partners. In mature digital economies, developers seek to extend their reach and distribute digital inventory at scale through more partners and chan
Xsolla Agency Launches to Empower Creators Across Entertainment-Based Intellectual Property5.3.2026 17:23:00 EET | Press release
Xsolla, a global video game commerce company, today launched Xsolla Agency, a comprehensive service connecting game developers with premium entertainment-based intellectual property (IP). The integrated offering addresses critical challenges for game creators: access to world-class IP, global monetization capabilities, and the operational infrastructure needed to build sustainable businesses. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260305044119/en/ Graphic: Xsolla Xsolla Agency simplifies access to entertainment-based licenses through expert-led negotiations and industry relationships, offering affordable, monetization-focused deals structured for maximum ROI. Strategic IP partnerships increase discoverability, reduce user acquisition costs, and drive higher player spend through impactful LiveOps events and promotional campaigns. The service is backed by the same commerce infrastructure powering 1,500+ game developers
Onego Bio and Sigma Foods Enter Collaboration to Strengthen Egg Protein Innovation and Supply Resilience5.3.2026 17:00:00 EET | Press release
Onego Bio, a food ingredient company producing non-animal egg protein, and Sigma Foods ("SIGMA"), a leading multinational food company, have entered into a collaboration agreement to evaluate the functionality and commercial potential of Bioalbumen®, a non-animal egg protein made with using precision fermentation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260305756400/en/ The partnership focuses on advancing ingredient innovation while addressing urgent challenges in today’s egg supply chain—including volatility, rising prices, and avian flu-related disruptions. Bioalbumen® offers a shelf-stable, animal-free alternative that delivers the same functional, nutritional, and sensory performance as traditional eggs, while helping safeguard supply continuity for food manufacturers. Additionally, this collaboration supports Sigma’s commitment to offering safe, nutritious, and high-quality food, while driving science-based inno
Vertex to Present New Data on JOURNAVX ® That Demonstrates Effective Pain Management Following Aesthetic and Reconstructive Procedures5.3.2026 17:00:00 EET | Press release
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced data from a Phase 4 study of JOURNAVX® (suzetrigine), a prescription non-opioid pain signal inhibitor for the treatment of moderate-to-severe acute pain, in adults, that demonstrated effective pain management and enabled opioid-free recovery after a broad range of plastic surgical procedures. These data showed that the majority of patients (90.9%) in the study were opioid free through the end of treatment (up to 14 days), demonstrating the potential for JOURNAVX as a core element of opioid-free multimodal treatment for moderate-to-severe acute pain after aesthetic and reconstructive procedures. In contrast, the literature shows opioid-free rates of less than 10% with multimodal treatment without JOURNAVX. These data will be presented at the American Academy of Pain Medicine (AAPM) PainConnect 2026 meeting, March 5-8, 2026, in Salt Lake City, UT. This Phase 4 open-label, multicenter, single-arm study evaluated JOURNAVX w
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