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
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
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
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.
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.
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
Resolved Sensitivity – 99.3%
Resolved Specificity – 98.1%
Resolved Sensitivity – 98.9%
Resolved Specificity – 99.6%
2. Centre for Disease Prevention and Control (ECDC) Seasonal Influenza
Factsheet for the General Public. [Online]
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):
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.
Contact: Jackie Lustig, Director, Corporate Communications,
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