|By PR Newswire||
|January 14, 2014 02:00 AM EST||
LYON, France, January 14, 2014 /PRNewswire/ --
Enigma Diagnostics Ltd, a leader in molecular diagnostic point-of-care (PoC) infectious disease testing, announces that it has today declared conformity with the requirements of the IVD Directive 98/79/EC for CE Marking of its Enigma® ML system and its first FluAB-RSV diagnostic assay.
The EnigmaML system uniquely combines a number of features critical to PoC testing. The fully automated raw sample to result instrument platform delivers results equivalent to central laboratory standards in up to 70 minutes, harnessing the speed and sensitivity of real-time PCR (polymerase chain reaction) with both simple and highly multiplexed assay formats. Its ease of use allows minimal training and has shown nil operator variance in trials, a major issue for other laboratory based diagnostic instruments where testing is undertaken by different operators. Together, these features will offer physicians a paradigm shift in their ability to make fully informed treatment decisions and fast and accurate diagnosis and treatment of patients.
The FluAB-RSV test can detect all currently circulating influenza and RSV viruses from nasopharyngeal swab samples, all tested in a single tube. Enigma is currently undertaking performance evaluation to extend the CE mark to other sample types for this test. In addition, Enigma is developing a pipeline of deeply multiplexed assays for the Enigma ML including panel tests for respiratory viruses, MDR-TB, and a wide range of other sexual diseases and hospital acquired infections.
Enigma's respiratory assays will target the increasing global influenza testing market where over 12 million influenza tests are undertaken annually. With fast and accurate testing ability, the Enigma ML will first market its assays in over 30 countries accepting CE marking and will then develop tests for the US FDA and other regulatory regimes, establishing leadership in global PoC testing.
John McKinley, Chairman of Enigma Diagnostics, said: "Achieving CE Mark for our Enigma ML and the FluAB-RSV test is a significant milestone for Enigma. Our FluAB-RSV assay will be quickly followed by a pipeline of multiplexed assays targeted at PoC testing and relevant to both developed and emerging healthcare regions. We are in the last stages of finalising our global commercialisation partnership strategy and our assay pipeline will be delivered in collaboration with a number of eminent reference laboratories and commercialisation partners in Europe and other regional markets."
About Enigma Diagnostics
Enigma Diagnostics is a global leader in Point-of-Care infectious disease testing. Leveraging its extensive range of proprietary technologies and Intellectual Property, the Company has developed the Enigma Mini Laboratory (ML) system, combining the speed and sensitivity of real-time PCR (polymerase chain reaction) with the simplicity needed for decentralised and Point-of-Care testing.
The Company is initially targeting the large and high growth infectious disease markets with a strong pipeline of multiplexed assays for respiratory diseases, sexually transmitted diseases and hospital acquired infections. The Enigma ML system benefits from a global manufacturing and supply chain providing scalable volume manufacture, delivering a cost base which will capture and establish leadership of developed and emerging Point-of-Care healthcare markets.
Enigma is headquartered at Porton Down, UK. For more information visit http://www.enigmadiagnostics.com
Enigma Diagnostics Limited
Consilium Strategic Communications
Amber Bielecka, Lindsey Neville, Ivar Milligan
Big Data, cloud, analytics, contextual information, wearable tech, sensors, mobility, and WebRTC: together, these advances have created a perfect storm of technologies that are disrupting and transforming classic communications models and ecosystems. In his session at @ThingsExpo, Erik Perotti, Senior Manager of New Ventures on Plantronics’ Innovation team, provided an overview of this technological shift, including associated business and consumer communications impacts, and opportunities it m...
Feb. 25, 2017 06:00 PM EST Reads: 7,680
With billions of sensors deployed worldwide, the amount of machine-generated data will soon exceed what our networks can handle. But consumers and businesses will expect seamless experiences and real-time responsiveness. What does this mean for IoT devices and the infrastructure that supports them? More of the data will need to be handled at - or closer to - the devices themselves.
Feb. 25, 2017 05:45 PM EST Reads: 2,209
When you focus on a journey from up-close, you look at your own technical and cultural history and how you changed it for the benefit of the customer. This was our starting point: too many integration issues, 13 SWP days and very long cycles. It was evident that in this fast-paced industry we could no longer afford this reality. We needed something that would take us beyond reducing the development lifecycles, CI and Agile methodologies. We made a fundamental difference, even changed our culture...
Feb. 25, 2017 05:45 PM EST Reads: 2,931
Updating DevOps to the latest production data slows down your development cycle. Probably it is due to slow, inefficient conventional storage and associated copy data management practices. In his session at @DevOpsSummit at 20th Cloud Expo, Dhiraj Sehgal, in Product and Solution at Tintri, will talk about DevOps and cloud-focused storage to update hundreds of child VMs (different flavors) with updates from a master VM in minutes, saving hours or even days in each development cycle. He will also...
Feb. 25, 2017 05:15 PM EST Reads: 2,678
SYS-CON Events announced today that Dataloop.IO, an innovator in cloud IT-monitoring whose products help organizations save time and money, has been named “Bronze Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Dataloop.IO is an emerging software company on the cutting edge of major IT-infrastructure trends including cloud computing and microservices. The company, founded in the UK but now based in San Fran...
Feb. 25, 2017 05:00 PM EST Reads: 2,931
Things are changing so quickly in IoT that it would take a wizard to predict which ecosystem will gain the most traction. In order for IoT to reach its potential, smart devices must be able to work together. Today, there are a slew of interoperability standards being promoted by big names to make this happen: HomeKit, Brillo and Alljoyn. In his session at @ThingsExpo, Adam Justice, vice president and general manager of Grid Connect, will review what happens when smart devices don’t work togethe...
Feb. 25, 2017 05:00 PM EST Reads: 1,515
A strange thing is happening along the way to the Internet of Things, namely far too many devices to work with and manage. It has become clear that we'll need much higher efficiency user experiences that can allow us to more easily and scalably work with the thousands of devices that will soon be in each of our lives. Enter the conversational interface revolution, combining bots we can literally talk with, gesture to, and even direct with our thoughts, with embedded artificial intelligence, whic...
Feb. 25, 2017 04:45 PM EST Reads: 1,734
Some people worry that OpenStack is more flash then substance; however, for many customers this could not be farther from the truth. No other technology equalizes the playing field between vendors while giving your internal teams better access than ever to infrastructure when they need it. In his session at 20th Cloud Expo, Chris Brown, a Solutions Marketing Manager at Nutanix, will talk through some real-world OpenStack deployments and look into the ways this can benefit customers of all sizes....
Feb. 25, 2017 04:30 PM EST Reads: 1,446
SYS-CON Events announced today that Addteq will exhibit at SYS-CON's @DevOpsSummit at Cloud Expo New York, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Addteq is one of the top 10 Platinum Atlassian Experts who specialize in DevOps, custom and continuous integration, automation, plugin development, and consulting for midsize and global firms. Addteq firmly believes that automation is essential for successful software releases. Addteq centers its products an...
Feb. 25, 2017 04:30 PM EST Reads: 341
In his session at @ThingsExpo, Sudarshan Krishnamurthi, a Senior Manager, Business Strategy, at Cisco Systems, will discuss how IT and operational technology (OT) work together, as opposed to being in separate siloes as once was traditional. Attendees will learn how to fully leverage the power of IoT in their organization by bringing the two sides together and bridging the communication gap. He will also look at what good leadership must entail in order to accomplish this, and how IT managers ca...
Feb. 25, 2017 04:15 PM EST Reads: 1,814
DevOps is being widely accepted (if not fully adopted) as essential in enterprise IT. But as Enterprise DevOps gains maturity, expands scope, and increases velocity, the need for data-driven decisions across teams becomes more acute. DevOps teams in any modern business must wrangle the ‘digital exhaust’ from the delivery toolchain, "pervasive" and "cognitive" computing, APIs and services, mobile devices and applications, the Internet of Things, and now even blockchain.
Feb. 25, 2017 04:15 PM EST Reads: 1,768
SYS-CON Events announced today that CA Technologies has been named “Platinum Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY, and the 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. CA Technologies helps customers succeed in a future where every business – from apparel to energy – is being rewritten by software. From ...
Feb. 25, 2017 03:30 PM EST Reads: 2,488
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, provided an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life settle...
Feb. 25, 2017 03:30 PM EST Reads: 1,586
Building a cross-cloud operational model can be a daunting task. Per-cloud silos are not the answer, but neither is a fully generic abstraction plane that strips out capabilities unique to a particular provider. In his session at 20th Cloud Expo, Chris Wolf, VP & Chief Technology Officer, Global Field & Industry at VMware, will discuss how successful organizations approach cloud operations and management, with insights into where operations should be centralized and when it’s best to decentraliz...
Feb. 25, 2017 03:15 PM EST Reads: 2,000
TechTarget storage websites are the best online information resource for news, tips and expert advice for the storage, backup and disaster recovery markets. By creating abundant, high-quality editorial content across more than 140 highly targeted technology-specific websites, TechTarget attracts and nurtures communities of technology buyers researching their companies' information technology needs. By understanding these buyers' content consumption behaviors, TechTarget creates the purchase inte...
Feb. 25, 2017 02:30 PM EST Reads: 1,740