WALTHAM, Mass., Oct. 2, 2017 /PRNewswire/ -- Alere Inc. (NYSE:
ALR), a global leader in rapid diagnostics, today announced that
its Alere™ i Influenza A & B 2 test has received 510(k)
marketing clearance from the U.S. Food and Drug Administration
(FDA) for the detection of influenza A and B infection in children
and adults.
Alere i Influenza A & B 2 is a second-generation rapid
molecular assay, which delivers lab accurate results in less time,
with the ability to report a positive result in as little as 5
minutes. This test will provide greater convenience with the
addition of room temperature storage and reduced warm-up time for
transport media samples. Alere i Influenza A & B 2 also offers
increased sample flexibility with nasopharyngeal swabs now
validated for direct use, as well as, in transport media.
Alere will shortly submit an application for CLIA (Clinical
Laboratory Improvement Amendments) waiver of the Alere i Influenza
A & B 2 test. Alere i testing applications have previously been
CLIA-waived for Influenza A & B, Strep A and RSV.
"Our innovative Alere i platform leads the way in the rapid
molecular segment with thousands of placements in hospitals,
clinics, physician offices and other point of care settings. With
this latest enhancement we now can offer 'early call out' of
positive results on all three available applications, Alere i
Influenza A & B 2, Alere i Strep A and Alere i RSV. In acute
care settings, every minute counts when assessing symptomatic
patients. 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 2 was
established in a multi-center, prospective clinical study conducted
at ten US trial sites during the 2016-2017 respiratory season, in
which 1074 prospective nasal or nasopharyngeal swab specimens,
collected from patients with influenza-like symptoms, were
evaluated with Alere™ i, and compared to an FDA-cleared real-time
Polymerase Chain Reaction (RT-PCR) test.
Alere has also expanded some of the features on the Alere i
instrument with the introduction of bi-directional connectivity and
an optional QC lockout function, to prevent testing of patient
samples if QC testing requirements are not met, enhancing overall
quality assurance.
The Alere i molecular platform was initially cleared for
marketing by the FDA for the detection and differentiation of
influenza A and B virus in June 2014,
with Alere i Strep A receiving FDA clearance in March 2015 and Alere i RSV receiving clearance in
October 2016. The Alere i Influenza A
& B 2 test will be available for use in hospitals in time for
the 2017-2018 respiratory season.
For more information on Alere i Influenza A & B 2, go to
www.alere.com/us.
About Influenza
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.1,2,3
About Alere
Alere believes that when diagnosing and
monitoring health conditions, Knowing now matters.™ Alere
delivers on this vision by providing reliable and actionable
information through rapid diagnostic tests, enhancing clinical and
economic health outcomes globally. Headquartered in Waltham, Mass., Alere focuses on rapid
diagnostics for infectious disease, cardiometabolic disease and
toxicology. For more information on Alere, please visit
www.alere.com.
1 U.S. Centers for Disease Control and Prevention (CDC). Key
facts about influenza (flu) & flu vaccine.
http://www.cdc.gov/flu/keyfacts.htm.
2 World Health Organization. Influenza.
http://www.who.int/immunization/topics/influenza/en/index.html.
3 Rapid influenza diagnostic tests increased antiviral use. J
Ped Infect Dis (2013) doi: 10.1093/jpids/pit071. First
published online: November 13,
2013.
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SOURCE Alere Inc.