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

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.

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"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.