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
Rubedo’s RLS-1496 Reduces Actinic Keratosis Pre-Cancerous Skin Lesions by 46% at Four Weeks with Minimal Irritation in Preliminary Results of Phase 1b/2a Study28.5.2026 15:30:00 EEST | Press release
Rubedo Life Sciences, Inc. (Rubedo), an AI-driven, clinical-stage biotech focused on selective cellular rejuvenation medicines targeting aging cells, today announced preliminary results from a Phase 1b/2a study of RLS-1496 in patients with actinic keratosis (AK), a common age-related condition resulting in precancerous skin lesions, that is most commonly seen after age 65.1 The open-label multi-center trial, conducted in the United States, assessed the safety, tolerability, and clinical effects of RLS-1496 1% cream in adult patients with AK on the forearms. RLS-1496 is the first selective glutathione peroxidase 4 (GPX4) modulator to be studied in human trials, and the first targeting cellular rejuvenation as a new therapeutic pathway in a novel category called Adaptive SenoTherapeutics. Interim data from the study were presented at the RBC Capital Markets Global Healthcare Conference in New York City on May 19, 2026. Preliminary RLS-1496 Actinic Keratosis Trial Results The Phase 1b/2a
ExaGrid Wins 5 Industry Awards at Network Computing Awards 202628.5.2026 15:00:00 EEST | Press release
ExaGrid®, the world’s largest independent backup storage vendor providing Tiered Backup Storage with the most Comprehensive Security and AI-Powered Retention Time-Lock for Ransomware Recovery, today announced that company was honored with five industry awards, including Air-gapped Ransomware Recovery Product of the Year, Bench Tested Product of the Year, Company of the Year, Data Protection Product of the Year, and the Storage Product of the Year during the Network Computing Awards ceremony, held in London on May 21, 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260528849813/en/ The ExaGrid team headed to the stage five times throughout the Network Computing Awards ceremony in London to accept awards for ExaGrid Tiered Backup Storage. Photo courtesy of Network Computing Awards. The Network Computing Awards are determined by public vote. The 2026 awards mark the eighth consecutive year of wins for ExaGrid at the Networ
Ardoq Launches AI-First Enterprise Architecture Platform28.5.2026 15:00:00 EEST | Press release
Ardoq, named a 5x Leader in the Gartner® Magic Quadrant™ for Enterprise Architecture Tools, today launched its AI-first enterprise architecture (EA) platform. The release grounds every Ardoq AI output in customers' live architecture data and introduces a new generation of AI agents capable of automating an estimated 40% of routine EA work. Architects today are being asked to defend decisions that generic AI is generating in seconds. Application rationalization choices. ERP transformation roadmaps. AI governance reviews. The questions land on the architect's desk, but the analysis underneath increasingly comes from AI assistants that do not know the architecture. Generic agents reason on whatever document is in front of them, not on the live relationships between applications, dependencies, capabilities, and risks. Ask a generic LLM to trace a five-step dependency chain across the real estate, and accuracy collapses. The answer arrives with confidence. The architect inherits the consequ
European DataWarehouse Launches DealDox ® , a Next-Generation Virtual Data Room Built specifically for the Securitisation Market28.5.2026 15:00:00 EEST | Press release
European DataWarehouse (EDW) announced today the launch of DealDox®, a secure virtual data room uniquely tailored to the needs of the securitisation and structured finance market. Developed in response to long‑standing challenges around transaction data and document management, DealDox provides a single, secure environment where all parties throughout the deal lifecycle can collaborate efficiently while maintaining high standards of security, governance, and regulatory alignment. DealDox enables the centralised management of transaction data and documentation, offering robust security, granular access controls, and clear audit trails. The platform integrates seamlessly with EDW’s existing regulatory reporting ecosystem, supporting smoother workflows from deal preparation through to disclosure and compliance. “As a market infrastructure, our role is to reduce complexity and make processes simpler and more transparent for all participants,” said Dr. Christian Thun, CEO of European DataWa
SLB and Vår Energi Expand Digital Collaboration to Scale Well and Integrated Field Development Planning28.5.2026 14:47:00 EEST | Press release
Global energy technology company SLB (NYSE: SLB) today announced an expanded collaboration with Vår Energi to scale well planning and integrated field development planning across its Norwegian Continental Shelf operations. With collaborative well planning already reducing cycle times from months to days and integrated field development planning expected to support similar benefits, the expanded deployment is designed to support faster, more consistent decision-making as operators work to sustain production from mature offshore assets while managing increasing development complexity. As part of the expanded collaboration, Vår Energi is deploying the Delfi™ digital platform to connect exploration, subsurface evaluation, well planning, subsea design, field development planning, and production in a cloud-native environment. By enabling teams to work concurrently using shared data and standardized workflows, the approach reduces handoffs and rework and supports more consistent, timely decis
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