SpeeDx Receives CE-IVD Clearance for ResistancePlus MG FleXible
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.
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.
- 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
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
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
Mary Kay Continues Its Commitment to Skin Science Research in Its First Ever Partnership With International Master Course on Aging Science29.1.2020 14:00:00 CET | Press release
Mary Kay, one of the world’s most innovative skincare companies, announces its partnership with the International Master Course on Aging Science (IMCAS). From January 30 – February 1, IMCAS will hold its annual 22nd World Congress in Paris, France, where prominent international experts in dermatology, plastic surgery and aging science will showcase and learn some of the latest research innovations with the goal of improving practice standards. With over 12,000 attendees expected to attend this year, 345 scientific sessions and 800 internationally renowned specialists presenting, the IMCAS 22nd World Congress offers a unique experience, with an exhaustive list of courses and sessions throughout the conference, designed to enrich one’s professional knowledge and skillset. “We are excited to continue partnering with the scientific community worldwide and are committed to sharing our innovative research with professionals in skin science and aging,” said Dr. Lucy Gildea, Chief Scientific O
Calvin Klein, Inc. and Calvin Klein Fragrances Announce CK ONE Underwear and Jeans and CK EVERYONE Fragrance29.1.2020 13:00:00 CET | Press release
Calvin Klein, Inc., a wholly owned subsidiary of PVH Corp. [NYSE: PVH], and Calvin Klein Fragrances, a division of Coty Inc. [NYSE: COTY], today revealed the new CK ONE underwear and jeans collection and CK EVERYONE, a clean fragrance, both inspired by the raw and rebel spirit of the original CK ONE. The collection and fragrance are unveiled in a global advertising campaign, proclaiming, “I am one, I am many. I love everyone of me.” This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200129005245/en/ (Photo: Business Wire) A tribute to individuality and the freedom of self-expression, the campaign shot by Glen Luchford stars a group of modern multi-hyphenates including musician and actor Eliot Sumner, skater and photographer Evan Mock, musician and makeup artist MLMA, rapper and dancer Priddy the Opp, and models Cara Taylor and Parker Van Noord. The energic, enigmatic visuals explore the many aspects of self, boldly embracing and
Moody’s Analytics Tops Five Categories in CeFPro™ Fintech Leaders Report29.1.2020 12:30:00 CET | Press release
Moody’s Analytics, a global provider of financial intelligence, has earned the #1 ranking in five categories in the new Center for Financial Professionals (CeFPro) Fintech Leaders 2020 report: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200129005359/en/ Balance Sheet Management Credit Risk Model Risk Regulatory Reporting Stress Testing We are the only firm to rank #1 in five of the report’s thirty individual categories. The report also features a “Top 50 Overall Ecosystem Rankings,” in which we rank #5. “We’re honored to be recognized in CeFPro’s Fintech Leaders report,” said Andy Frepp, Executive Director at Moody’s Analytics. “We build modular and scalable technology solutions that harness our industry-leading data and analytics, all with the goal of helping customers make better, faster decisions. This strong showing validates our efforts and highlights our extensive capabilities.” “FinTech Leaders places Moody’s Analy
Janssen Announces European Commission Approval for Expanded Use of Erleada®▼ (apalutamide) for Treatment of Patients with Metastatic Hormone-Sensitive Prostate Cancer29.1.2020 10:21:00 CET | Press release
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the European Commission (EC) has granted marketing authorisation for the expanded use of Erleada®▼ (apalutamide) to include the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT). “Prostate cancer is the most prevalent form of cancer in men throughout Europe, and the expanded approval of apalutamide marks a significant advancement for those living with mHSPC,” said Prof. Dr. med. Axel S. Merseburger, Chairman of the Department of Urology, Campus Lübeck, University Hospital Schleswig-Holstein, Kiel, Germany. “In prostate cancer treatment, our primary goal is always to delay progression of disease and prolong survival, to ensure the best possible outcomes for patients. Today’s news is therefore an encouraging development for patients within Europe, for whom the importance of an additional treatment option that can both delay p
Dole Receives Social Responsibility Award from Costa Rican-North American Chamber of Commerce29.1.2020 09:58:00 CET | Press release
Dole Food Company announced that on November 22, The Standard Fruit Company of Costa Rica S.A., a subsidiary of Dole Food Company, received the “Social Responsibility in Action” award from The Costa Rican-North American Chamber of Commerce (AmCham) in connection to the company’s Green Star Initiative. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200129005318/en/ (LtoR): Roberto Cordero – Climate Change & Sustainability Services Partner (Ernst & Young). Jonatan Steinig – Technical Advisor for Business & Biodiversity in Central America & Dominican Republic Program GIZ. Melina Mardones - Technical Advisor for the Business & Biodiversity in Central America & Dominican Republic Program GIZ. José Alberto Samudio – Senior Environmental Technician. Edwin Retana - Senior Environmental Technician. Natalia Díaz – Public Affairs / Dole Tropical Products Latin America. Elías Solías – President of AmCham Costa Rica. José Pablo Masís – H
Temenos and Google Cloud Announce Global Strategic Partnership to Accelerate Banks’ Digital Transformation in the Cloud29.1.2020 09:05:00 CET | Press release
Temenos (SIX: TEMN), the banking software company, and Google Cloud today announced a global, strategic partnership to help financial services organizations run mission-critical banking software and applications on Google Cloud, create profitable business models, and improve and differentiate their customer experiences. The two companies began collaborating in 2019 to integrate Temenos cloud-native, cloud-agnostic software into Google Cloud and have demonstrated success with joint banking customers in Europe and Asia. Under this expanded partnership, Temenos’ full suite of banking software and applications will now be available on Google Cloud, and the two companies will help banks go to market faster, open up new business models, and achieve tangible business benefits. More than 3,000 financial services institutions around the world leverage Temenos’ modern, cloud-native and API-first technology. As a part of this strategic partnership, banks can run Temenos’ applications in Google Cl