), a global provider of point-of-care rapid diagnostic and health
information solutions, spiked nearly 2.6% yesterday after the U.S.
Food and Drug Administration (FDA) approved its i Influenza A &
The molecular test is the first-of-its-kind designed to detect and
differentiate between two most common types of flu virus -
influenza A and B - in less than 15 minutes. The test uses nasal
swab specimens from patients to extract and analyze the DNA or RNA
strands for evidence of the viruses.
Alere i Influenza A & B allows rapid influenza diagnosis. It
delivers timely and lab-accurate results on a user-friendly
platform, thus ensuring appropriate care for patients as early as
The clinical performance of Alere i Influenza A & B was
established in a multi-center, prospective study conducted at 8
U.S. trial sites during the 2012-2013 flu season. A total of 585
prospective nasal swab specimens were collected from patients with
The samples were evaluated with Alere i and compared to viral
culture. All specimens that generated 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 of
Alere i Influenza A & B was launched earlier this year in
Europe. Presently, clinical trials to obtain a waiver for the test
from the Clinical Laboratory Improvement Amendments (CLIA) have
been completed. Going forward, Alere expects to submit a CLIA
waiver filing for the influenza test to the FDA in the beginning of
fiscal 2014 third quarter.
Influenza is currently estimated to affect 25-50 million people in
the U.S. and causes as many as 150,000 hospitalizations per year.
The annual death toll has ranged from 3,000 to 49,000. Influenza
also poses significant economic burden, which includes medical care
expenses and loss of productivity.
By providing an efficient molecular technology, Alere intends to
deliver clinically meaningful and actionable results to clinicians
- enabling a quicker and appropriate treatment for influenza
patients. Rapid diagnosis of influenza can help reduce length of
hospital stays, secondary complications and hospital care expenses.
Currently, Alere carries a Zacks Rank #4 (Sell). Better-ranked
stocks in the medical products industry include
ICU Medical, Inc.
). All these stocks carry a Zacks Rank #2 (Buy).
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