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.
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
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
New nCipher HSM as a Service Delivers High-Assurance Security for Organizations Adopting Cloud-First Strategies17.9.2019 10:01:00 EEST | Press release
nCipher Security, an Entrust Datacard company, announces nShield as a Service, a cloud-based hardware security module (HSM) service that allows organizations to protect sensitive data and applications and helps meet compliance mandates – simply and efficiently, using on-demand cryptography. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190917005391/en/ How nCipher Security nShield as a Service works (Graphic: Business Wire) “Organizations embracing cloud-first strategies require cloud-first encryption,” said Peter Galvin, vice president of strategy, nCipher Security. “This means remote, automated management at scale, and flexible access control both in the cloud and onsite. nShield as a Service makes it easy to adopt a secure, multi-cloud encryption strategy using the same nShield HSMs organizations deploy onsite today.” nShield as a Service is ideal for cloud-first strategies, selective cloud migration, or adding HSM capac
Netsam boosts metro network capacity with ADVA technology17.9.2019 10:00:00 EEST | Press release
ADVA (FSE: ADV) today announced that Netsam has deployed its FSP 3000 and FSP 150 to dramatically expand its metro network and answer fierce data demand. Featuring the ADVA FSP 3000 open line system (OLS) with micro-ROADMs and ADVA FSP 150 demarcation technology, the new solution gives the Swedish communication service provider (CSP) the power to quickly and easily turn up new high-value services. The flexible ROADM-based photonic layer ensures Netsam’s fiber resources are used with optimal efficiency. With this and the ADVA FSP 150 deployed at customer premises, Netsam is able to provide SLA-based business services with speeds up to 100Gbit/s. ADVA’s partner NetNordic, a leading solutions integrator in Scandinavia, also played a key role in the project. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190917005130/en/ Netsam has deployed the FSP 3000 and FSP 150 to quickly and easily turn up new high-value services (Photo: Bu
Riversand Technologies Appoints New EVP to Lead Growth in Europe and Middle East17.9.2019 08:00:00 EEST | Press release
Riversand Technologies, a leading software provider of Cloud-native SaaS Master Data Management (MDM) and Product Information Management (PIM), announces the appointment of Mr. Mikkel Jensen as executive vice president for Europe and the Middle East regions. Mikkel will be responsible for overseeing sales and revenue growth in Europe and the Middle East and managing these regions’ operations. He has more than 18 years of experience in Master Data Management. Previously, he held a variety of roles with increasing responsibility at Stibo Systems, including EVP, and VP of Product Strategy. “We are delighted to bring onboard a leader of the caliber of Mikkel with his depth and breadth of knowledge, to head Riversand’s European and Middle East regions,” says Upen Varanasi, founder and CEO at Riversand. Riversand has steadily increased its footprint in Europe over the past few years, successfully establishing itself as a Product Information Management leader serving top European brands acros
Statement From The We Company17.9.2019 05:57:00 EEST | Press release
The We Company (the “Company”) has issued the following statement: “The We Company is looking forward to our upcoming IPO, which we expect to be completed by the end of the year. We want to thank all of our employees, members and partners for their ongoing commitment.” This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities. Any offers, solicitations of offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933. A registration statement relating to these securities has been filed with the Securities and Exchange Commission but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. Copies of the preliminary prospectus relating to the offering, when available, may be obtained from the Company at 115 West 18th Street, New York, New York 10011. View source
PSE plans to become part of Siemens17.9.2019 03:00:00 EEST | Press release
Process Systems Enterprise (PSE), the leading supplier of Advanced Process Modelling (APM) software and services, today announced that it plans to be acquired by Siemens AG in a transaction scheduled to close in Q4 2019. The 160-strong PSE operation will be integrated into the Process Automation Business Unit of Siemens Digital Industries. The current PSE management team will remain in place. PSE’s advanced process models are used within digital R&D, design and operations in the process industries to help make fast, safe and more efficient decisions through rapid and effective exploration of the decision space. The technology is widely used in the chemicals, petrochemicals, pharmaceuticals and food industries to accelerate innovation, improve process design and operation, streamline R&D and manage technology risk. PSE’s model-based solutions span the entire process lifecycle via a unified and integrated set of tools. These strongly complement the Siemens portfolio in the process indust
Velodyne Executive Addresses Why Lidar is Necessary for Safe Vehicle Automation at IAA 2019 Conference17.9.2019 01:19:00 EEST | Press release
Marta Hall, President and Chief Business Development Officer of Velodyne Lidar, Inc. will address the future of vehicle safety at the IAA 2019 Conference in Frankfurt. Hall’s presentation will highlight the development of advanced, cost-effective lidar technology for advanced driver assistance systems (ADAS) and autonomy, particularly to protect pedestrians, assist drivers and save lives. The event will take place at Velodyne’s booth (Hall 8.0, Booth A13) on September 18 at 11:00 a.m. CEST (GMT+2). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190916005913/en/ Marta Hall, President and Chief Business Development Officer of Velodyne Lidar, Inc., will address why lidar is necessary for safe vehicle automation at the IAA 2019 Conference. (Photo: Velodyne Lidar) “There are dozens of companies working on autonomous vehicles. Incredible possibilities have opened as a result of the engineering efforts towards autonomy. In rolling
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