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
Swedish Court Further Reschedules Delivery of Judgment in PriceRunner Vs Google Antitrust Case24.6.2026 21:55:00 EEST | Press release
Klarna Group plc (NYSE: KLAR) wishes to update investors that the Patent and Market Court in Stockholm, Sweden (Patent- och marknadsdomstolen) has again postponed publication of its judgment in the antitrust damages proceedings brought by PriceRunner, a Klarna subsidiary, against Google. The Court has rescheduled publication of its judgment from June 26, 2026 to July 1, 2026 at 13:00 CET. As with the Court's two previous notifications, the rescheduling is a procedural decision by the Court and relates solely to the timing of the judgment delivery. In its notification, the Court cited high workload as the reason for needing additional time to finalize the judgment. No inference about the outcome should be drawn from it. Important Notice The outcome of the proceedings is inherently uncertain. No assurance can be given that PriceRunner will succeed on liability or quantum. Any award would be subject to appeal by Google, to sharing arrangements with former PriceRunner shareholders and Klar
Vertex Energy Announces 6,000 bpd Group III Base Oil Expansion Project24.6.2026 17:00:00 EEST | Press release
Vertex Energy, Inc. (“Vertex” or the “Company”) today announced it is advancing a project at its Mobile, Alabama refinery to produce crude-derived conventional Group III base oils through the Company’s existing hydrocracker and related processing infrastructure, providing lubricant manufacturers and blenders with an additional domestic source of high-quality Group III supply. The project is designed to add an incremental 6,000 barrels per day of conventional Group III production capacity and support production of 4 cSt, 6 cSt, and 8 cSt Group III base oils using an existing crude-derived hydrocracked vacuum gas oil stream produced at the Company’s Mobile, Alabama refinery. Combined with the Company’s existing re-refined Group III base oil production, this additional capacity is expected to make Vertex the leading Group III producer in North America. Vertex has completed preliminary design work and has procured a high-pressure lubricants hydrotreating unit. The Company plans to start pr
Taktile Secures $110M in Goldman Sachs-led Series C to Power AI Transformation in Financial Institutions24.6.2026 16:30:00 EEST | Press release
Taktile, the leader in AI transformation for financial institutions, today announced its $110 million Series C fundraise. Growth Equity at Goldman Sachs Alternatives led the round, with participation from Balderton Capital, Index Ventures, Tiger Global, Y Combinator, and Dig Ventures. Taktile Fast Facts Taktile enables banks and insurers to transform into AI-native organizations that are increasingly powered by autonomous agents. Demand for Taktile accelerated in 2025, as AI models became capable of automating high-stakes decisions that previously required hours of manual work—from underwriting business loans and assessing claims to catching financial crime. Customers automate and optimize decisions with Taktile by combining its financial services expertise and product built for sector-specific AI use cases. One of the world’s largest insurers is running multiple use cases on Taktile, with projected cost efficiencies of over $90M in claims processing alone. Taktile’s team has a proven
New MetLife Study Reveals a 72% “Confidence Gap” in Ability to Recover from Life's Setbacks24.6.2026 16:25:00 EEST | Press release
A new multinational study from MetLife reveals a striking “confidence gap”: while most adults describe themselves as resilient, their confidence drops by 72% when faced with real-life setbacks. The Confident Pathways Report, conducted across the United States, United Kingdom, Japan, and Mexico, was designed to better understand how confidence is built and sustained throughout life. The findings underscore the role of opportunity, preparedness, and support in building confidence - factors that help people navigate uncertainty, recover from setbacks and pursue their goals. At a time when soccer is bringing people and communities together around the world, the findings also highlight how early childhood experiences such as sports, education, and mentorship can help foster resilience and gain confidence from a young age. Key findings across the four countries surveyed include: Confidence drops by 72% when adults consider their ability to recover from setbacks. Respondents were far more lik
StatLab Launches CytoPath Disc, Advancing Standardized Cell Block Preparation Worldwide24.6.2026 16:08:00 EEST | Press release
StatLab Medical Products, a leading global developer and manufacturer of pathology supplies and equipment, today announced the global launch of the CytoPath Disc, an innovative cell block preparation technology designed to standardize and simplify cell block preparation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260624368623/en/ Developed as an alternative to traditional cell block methods, which convert concentrated cells suspended in fluid into a paraffin-embedded format for slide-based evaluation, the patent‑pending CytoPath Disc offers a more streamlined and efficient approach. The CytoPath Disc absorbs concentrated cells within a simple, sponge-like matrix, which is then processed, embedded, stained, and sectioned using standard histology workflows. Traditional cell block preparation methods often present challenges in achieving consistent results due to complex procedures, as well as the need for additional equipm
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