Alere Receives FDA Clearance for Alere™ i Influenza A and B Test
First-ever Platform to Deliver Highly Accurate, Molecular Results in Under 15
WALTHAM, Mass., June 16, 2014
WALTHAM, Mass., June 16, 2014 /PRNewswire/ --Alere Inc. (NYSE: ALR), a
leading global provider of point-of-care rapid diagnostic and health
information solutions, today announced that it has received clearance from the
U.S. Food and Drug Administration (FDA) for 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.
"By providing the speed of a rapid test with molecular technology, Alere i
delivers clinically meaningful and actionable results to clinicians – enabling
them to treat patients more quickly and appropriately," said Avi Pelossof,
Alere Global President of Infectious Disease.
The clinical performance of Alere i Influenza A & B was established in a
multi-center, prospective study conducted at eight U.S. trial sites during the
2012-2013 flu season, in which 585 prospective nasal swab specimens, collected
from patients presenting with influenza-like symptoms, were evaluated with
Alere i, and compared to viral culture. All specimens generating discrepant
results between the Alere i Influenza A & B test and viral culture were tested
using an FDA cleared RT-PCR assay to confirm influenza status.
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.Unlike polymerase chain reaction (PCR) testing, Alere's proprietary
Molecular. In Minutes™ (MIM) isothermal nucleic acid amplification technology
(iNAT) does not require lengthy and complex thermo cycling or DNA
purification, and can therefore deliver PCR-caliber results more quickly – and
in a broad range of settings. Alere i tests for Strep A, C. difficile,
respiratory syncytial virus (RSV) and chlamydia / gonorrhea are currently in
Alere i Influenza A & B was launched earlier this year in Europe. Clinical
trials for CLIA waiver of Alere i Influenza A & B have been completed and the
Company expects to submit a CLIA waiver filing to the FDA in early Q3 2014.
Clinical trials for Strep A have also been completed and the Company expects
to file for 510k clearance in Q3 2014.
For more information on Alere i Influenza A & B, go towww.alere-i.com/us.
Each year, a combination of influenza A and B virus strains circulate within
the United States. The burden of influenza is currently estimated to be 25-50
million cases per year, and the disease and its complications cause as many as
150,000 hospitalizations and 3,000 - 49,000 deaths annually. Influenza also
poses a significant economic burden including medical care expenses and loss
of productivity. 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.^,,
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, toxicology, cardiology and diabetes. Alere is
headquartered in Waltham, Massachusetts. For more information regarding Alere,
please visit www.alere.com.
^ U.S. Centers for Disease Control and Prevention (CDC). Key facts about
influenza (flu) & flu vaccine. http://www.cdc.gov/flu/keyfacts.htm.
^ World Health Organization. Influenza.
^ Rapid influenza diagnostic tests increased antiviral use. J Ped Infect
Dis (2013) doi: 10.1093/jpids/pit071. First published online: November 13,
SOURCE Alere Inc.
Contact: Jackie Lustig, Director, Corporate Communications,
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