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
Digital Reef Signs Offtake Agreement with Oreasoc Agriculture to Mitigate the Environmental Footprint of Data Centre Growth Through Rainforest Protection, Appointing Xange.com as Digital MRV Partner25.9.2026 22:19:00 EEST | Press release
At Climate Week NYC, Digital Reef and Oreasoc Agriculture Inc. sign an offtake agreement connecting Digital Reef’s 3.3 GW data centre pipeline with environmental assets exceeding 30 million hectares of South American Amazon rainforest, mitigating the environmental footprint of data centre growth through rainforest protection and restoration where Oreasoc works alongside local communities to protect biodiversity, develop sustainable economies and safeguard their territories. Xange.com are appointed as digital MRV technology partner to monitor the data centres and rainforest where Digital Reef will purchase verified environmental assets generated by Oreasoc, supporting the development of low-carbon data centres mitigating their environmental footprint through the protection of high-integrity natural ecosystems across the South American Amazon, whilst advancing sustainable economic development. AI and data centre demand is driving rapid growth, with the International Energy Agency project
NetApp Announces Intent to Acquire PEAK:AIO to Advance Scalable AI Infrastructure Architecture25.9.2026 16:00:00 EEST | Press release
NetApp® (NASDAQ: NTAP), the intelligent data infrastructure company, today announced its intent to acquire PEAK:AIO, a pioneer in next-generation metadata architecture and high-performance parallel file systems. The planned acquisition is expected to accelerate NetApp's AI infrastructure roadmap by augmenting metadata services and parallel namespace innovation designed to help AI clouds scale shared storage alongside growing GPU clusters. As AI becomes embedded in every enterprise workload, organizations are confronting a new challenge: traditional storage architectures were not designed for the unprecedented scale, concurrency, and performance requirements of AI factories, AI clouds, and next-generation data-intensive applications. NetApp is building an architecture that disaggregates metadata from data and enables metadata services to scale independently, creating a foundation for AI infrastructure capable of supporting trillions of files, exabyte-scale environments, and massively pa
MultiBank Group Secures Two Awards at Forex Expo Dubai 202625.9.2026 15:57:00 EEST | Press release
MultiBank Group, one of the world’s largest financial derivatives institutions, received two awards during its participation at Forex Expo Dubai 2026, held on 22 and 23 September at Dubai World Trade Centre. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260925539591/en/ MultiBank Group was named “Best Global Institutional Financial Ecosystem of the Year” and received the award for “Excellence in Global Financial Markets Innovation and Community Impact.” The Group was named “Best Global Institutional Financial Ecosystem of the Year” and received the award for “Excellence in Global Financial Markets Innovation and Community Impact.” The first award recognised the strength and breadth of MultiBank Group’s global institutional offering, which brings together trading, liquidity, technology, infrastructure, execution, market access and tailored client solutions within an integrated financial ecosystem. The second award acknowledg
Croma-Pharma Introduces saypha ® volume prime Lidocaine25.9.2026 15:04:00 EEST | Press release
Croma-Pharma introduces saypha® volume prime Lidocaine, a cross-linked hyaluronic acid dermal filler that replaces saypha® volume Lidocaine within the company's saypha® portfolio. The new product offers physicians a more versatile solution with expanded indications for both midface volumization and nasolabial folds, backed by strong clinical data. 1,2 saypha® volume prime Lidocaine demonstrated non-inferiority to comparatora in a randomized, subject- and evaluator-blinded, controlled, non-inferiority multicenter, parallel group comparison study with almost 500 patients.2 In the clinical evaluation, a high patient satisfaction highlights improved midface fullness, smoothness and contour, consistent with a rheologic profile designed to provide volumization in the mobile midface.b,2 With saypha® volume prime Lidocaine, Croma-Pharma further strengthens its product range, reflecting the company's long-standing commitment to scientific excellence and continuous product innovation, and provid
Abacus Global Management Completes Landmark $400 Million Securitization25.9.2026 15:00:00 EEST | Press release
Abacus Global Management, Inc. (“Abacus” or the “Company”) (NYSE: ABX), a financial services company specializing in alternative asset management, with a focus on longevity-based assets and personalized financial planning, today announced the closing of a dual-tranche securitization collateralized by a diversified portfolio of life insurance policies. The total structure is valued at over $400 million including the Class A and Class B notes and the residual interest. The notes have received an investment-grade rating from a third-party rating agency. The offering was oversubscribed and was upsized in response to investor demand. Abacus expects to use the net proceeds from the transaction to support continued policy origination and fund general corporate purposes. More fundamentally, this transaction advances the growth of the Company's asset management business. In the transaction, a special-purchase vehicle issued investment-grade notes backed by a pool of policies, which the Company
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