Welcome!

News Feed Item

First Rapid Molecular Diagnostic Test to Detect Influenza A and B Virus in Under 15 Minutes Now Available in Europe on the Alere i Platform

Alere™ i Transforms Influenza Testing by Providing Highly Accurate, Molecular Results via a Simple, User-Friendly Platform

WALTHAM, Mass., Jan. 23, 2014 /PRNewswire/ -- Alere Inc. (NYSE: ALR), a  leading global provider of point-of-care rapid diagnostic and health information solutions, today announced the availability in Europe of the Alere i Influenza A & B test, the first and only molecular test to detect and differentiate influenza A and B virus in less than 15 minutes. The test is now commercially available in Austria, France, Spain, Switzerland, Germany, Italy and the UK.

(Photo:  http://photos.prnewswire.com/prnh/20140123/NE51672 )

"Alere i is a transformational platform that allows healthcare professionals to make a rapid influenza diagnosis – and effective patient management decisions – in a clinically meaningful timeframe, whether the patient is in the physician office, emergency department or urgent care clinic," said Avi Pelossof, Alere Global President of Infectious Disease. "Alere i also significantly expands screening opportunities by making innovative, rapid molecular testing technology available at the point of care as well as in laboratory settings." 

Molecular testing involves the extraction and analysis of DNA or RNA strands to detect sequences associated with viral and bacterial causes of infections. Alere i Influenza A & B is the first molecular diagnostic test that delivers actionable, lab-accurate results in less than 15 minutes on a user-friendly platform. 1 The proprietary technology utilizes isothermal nucleic acid amplification technology (iNAT), which, unlike polymerase chain reaction (PCR) testing, does not require temperature cycling and can therefore deliver results more quickly – Molecular. In Minutes™ (MIM) – and to a broader range of settings. Alere i tests for Strep A, C. difficile, respiratory syncytial virus (RSV) and chlamydia / gonorrhoea are currently in development.

Each year, a combination of influenza A and B virus strains circulate within Europe. Up to 40,000 people die each year from influenza in the EU, according to the European Centre for Disease Prevention and Control (ECDC). The disease also poses a significant economic burden including medical care expenses and loss of productivity.2 Rapid diagnostics with increased sensitivity are essential for the reliable detection of influenza A and B, enabling healthcare professionals to make immediate, effective treatment decisions and prevent unnecessary prescribing of antibiotics and antiviral medications. Rapid diagnosis of influenza can help reduce length of hospital stays, secondary complications and the cost of hospital care, and allow effective implementation of infection control measures.3,4

Alere i Influenza A & B is currently under regulatory review in the United States by the US Food and Drug Administration (FDA) and is not available in the US pending completion of such review.

For more information, visit www.Alere-i.com

About Alere
By developing new capabilities in near-patient diagnosis, monitoring and health information technology, Alere enables individuals to take charge of improving their health and quality of life at home. Alere's global leading products and services, as well as its new product development efforts, focus on infectious disease, cardiology, toxicology and diabetes. Alere is headquartered in Waltham, Massachusetts. For more information regarding Alere, please visit www.alere.com.   

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the federal securities laws, including statements regarding the expected future availability of the product in certain markets. These statements reflect Alere's current views with respect to future events and are based on their current assumptions and information currently available.  Actual results may differ materially due to numerous factors including, without limitation, the timing of regulatory decision making, as well as the other risks described in the "Risk Factors" section of Alere's Annual Report on Form 10-K filed with the SEC on March 1, 2013, as amended. The parties undertake no obligation to update any forward-looking statements contained herein.

References:

1. The clinical performance of Alere i Influenza A & B was established in a multi-center, prospective study conducted at eight US trial sites during the 2012-2013 respiratory season. A total of 571 prospective nasal swab specimens, collected from patients of all ages presenting with influenza-like symptoms, were evaluated with Alere i Influenza A & B, and compared to viral culture. All discrepant samples were tested on an FDA-cleared RT-PCR assay at a central testing laboratory to confirm influenza status.

Alere i Influenza A & B Performance vs. Culture
Discrepant Results Resolved by RT-PCR

Influenza A:
Resolved Sensitivity – 99.3%
Resolved Specificity – 98.1%

Influenza B:
Resolved Sensitivity – 98.9%
Resolved Specificity – 99.6%

2. Centre for Disease Prevention and Control (ECDC) Seasonal Influenza Factsheet for the General Public. [Online] http://www.ecdc.europa.eu/en/healthtopics/seasonal_influenza/basic_facts/Pages/factsheet_general_public.aspx.  Date accessed: 29 October 2013.

3. Williams, KM, Jackson MA, Hamilton M. Rapid Diagnostic Testing for URIs in Children: Impact on Physician Decision Making and Cost. Infect. Med. 19(3): 109-111, 2002.

4. Bonner, A.B. et al. Impact of the Rapid Diagnosis of Influenza on Physician Decision-Making and Patient Management in the Pediatric Emergency Department: Results of a Randomized, Prospective, Controlled Trial. Pediatrics. 2003 Vol. 112 No. 2.

SOURCE Alere Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Join us at Cloud Expo | @ThingsExpo 2016 – June 7-9 at the Javits Center in New York City and November 1-3 at the Santa Clara Convention Center in Santa Clara, CA – and deliver your unique message in a way that is striking and unforgettable by taking advantage of SYS-CON's unmatched high-impact, result-driven event / media packages.
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management...
There will be new vendors providing applications, middleware, and connected devices to support the thriving IoT ecosystem. This essentially means that electronic device manufacturers will also be in the software business. Many will be new to building embedded software or robust software. This creates an increased importance on software quality, particularly within the Industrial Internet of Things where business-critical applications are becoming dependent on products controlled by software. Qua...
As someone who has been dedicated to automation and Application Release Automation (ARA) technology for almost six years now, one of the most common questions I get asked regards Platform-as-a-Service (PaaS). Specifically, people want to know whether release automation is still needed when a PaaS is in place, and why. Isn't that what a PaaS provides? A solution to the deployment and runtime challenges of an application? Why would anyone using a PaaS then need an automation engine with workflow ...
With an estimated 50 billion devices connected to the Internet by 2020, several industries will begin to expand their capabilities for retaining end point data at the edge to better utilize the range of data types and sheer volume of M2M data generated by the Internet of Things. In his session at @ThingsExpo, Don DeLoach, CEO and President of Infobright, will discuss the infrastructures businesses will need to implement to handle this explosion of data by providing specific use cases for filte...
SYS-CON Events announced today that Pythian, a global IT services company specializing in helping companies adopt disruptive technologies to optimize revenue-generating systems, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Founded in 1997, Pythian is a global IT services company that helps companies compete by adopting disruptive technologies such as cloud, Big Data, advanced analytics, and DevO...
SYS-CON Events announced today that Avere Systems, a leading provider of enterprise storage for the hybrid cloud, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Avere delivers a more modern architectural approach to storage that doesn’t require the overprovisioning of storage capacity to achieve performance, overspending on expensive storage media for inactive data or the overbuilding of data centers ...
CIOs and those charged with running IT Operations are challenged to deliver secure, audited, and reliable compute environments for the applications and data for the business. Behind the scenes these tasks are often accomplished by following onerous time-consuming processes and often the management of these environments and processes will be outsourced to multiple IT service providers. In addition, the division of work is often siloed into traditional "towers" that are not well integrated for cro...
SYS-CON Events announced today that Alert Logic, Inc., the leading provider of Security-as-a-Service solutions for the cloud, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Alert Logic, Inc., provides Security-as-a-Service for on-premises, cloud, and hybrid infrastructures, delivering deep security insight and continuous protection for customers at a lower cost than traditional security solutions. Ful...
Recognizing the need to identify and validate information security professionals’ competency in securing cloud services, the two leading membership organizations focused on cloud and information security, the Cloud Security Alliance (CSA) and (ISC)^2, joined together to develop an international cloud security credential that reflects the most current and comprehensive best practices for securing and optimizing cloud computing environments.
SYS-CON Events announced today that FalconStor Software® Inc., a 15-year innovator of software-defined storage solutions, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. FalconStor Software®, Inc. (NASDAQ: FALC) is a leading software-defined storage company offering a converged, hardware-agnostic, software-defined storage and data services platform. Its flagship solution FreeStor®, utilizes a horizonta...
In most cases, it is convenient to have some human interaction with a web (micro-)service, no matter how small it is. A traditional approach would be to create an HTTP interface, where user requests will be dispatched and HTML/CSS pages must be served. This approach is indeed very traditional for a web site, but not really convenient for a web service, which is not intended to be good looking, 24x7 up and running and UX-optimized. Instead, talking to a web service in a chat-bot mode would be muc...
SYS-CON Events announced today that Column Technologies will exhibit at SYS-CON's @DevOpsSummit at Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Established in 1998, Column Technologies is a global technology solutions provider with over 400 employees, headquartered in the United States with offices in Canada, India, and the United Kingdom. Column Technologies provides “Best of Breed” technology solutions that automate the key DevOps principal...
SYS-CON Events announced today that AppNeta, the leader in performance insight for business-critical web applications, will exhibit and present at SYS-CON's @DevOpsSummit at Cloud Expo New York, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. AppNeta is the only application performance monitoring (APM) company to provide solutions for all applications – applications you develop internally, business-critical SaaS applications you use and the networks that deli...
Fortunately, meaningful and tangible business cases for IoT are plentiful in a broad array of industries and vertical markets. These range from simple warranty cost reduction for capital intensive assets, to minimizing downtime for vital business tools, to creating feedback loops improving product design, to improving and enhancing enterprise customer experiences. All of these business cases, which will be briefly explored in this session, hinge on cost effectively extracting relevant data from ...