Alere's Flu Test Gains FDA Waiver - Analyst Blog
28 1월 2012 - 1:52AM
Zacks
Alere (ALR), a medical products company focused
on integrating rapid diagnostics with health management, recently
revealed that it has received a confirmation that the U.S. Food and
Drug Administration (“FDA”) had cleared the Alere Influenza A&B
Test for the domestic market.
The test has been classified by the Clinical Laboratory
Improvement Amendments (CLIA), the U.S. regulatory standards for
all human clinical laboratory testing, as “waived test."
Alere’s new offering is a very sensitive rapid test designed for
use in the doctor’s chamber. It is expected to assist medical
practitioners take better care of patients with influenza-type
diseases.
The Alere Influenza test received its waived status following
numerous studies to validate the test and after substantial
collaboration with the FDA. Alere believes that by introducing this
product in the waived segment of the market place, it is providing
medical practitioners with a new tool in the fight against flu.
The Alere Influenza A&B Test utilizes exceedingly sensitive
antibodies to find influenza types A and B antigen. This test
requires a nasal swab and sample collection is less invasive. This
test gives results in just 10 minutes, which permits doctors to
rapidly administer treatment to their patients.
Diagnostic tests are shifting closer to the consumers and into
the home testing market, as more diagnostic tests are being
developed to monitor patients rather than simply diagnose them.
Alere's strategy of combining disease management with point-of-care
testing (“POCT”), in a manner that encourages patients to take
responsibility over their overall health care, is viewed as a
prudent approach while at the same time ensuring affordability.
In addition to growing its revenues through a combination
strategy of continued acquisitions and measured organic growth, the
company is committed to improving its operating margin. Further,
its product pipeline is strong, which has been developed through a
combination of internal R&D as well as serial acquisitions. One
of the company’s competitors is Abaxis (ABAX).
ABAXIS INC (ABAX): Free Stock Analysis Report
ALERE INC (ALR): Free Stock Analysis Report
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