Alere rapid flu test receives CLIA waiver from FDA

Waltham, Massachusetts – Alere Inc., a global leader in enabling individuals to take charge of their
health at home through the merger of rapid diagnostics and health management,
received confirmation that The U.S. Food and Drug Administration (FDA) has
cleared the Alere™ Influenza A&B Test for the U.S. market, categorizing it
as CLIA-waived.  This highly sensitive
rapid test is intended for use in the physicians office and will help
healthcare practitioners manage patients with influenza-like illness more
effectively.

The U.S. Congress passed the Clinical Laboratory Improvement
Amendments (CLIA) in 1988 to set quality standards for all laboratory testing
and ensure that tests, no matter where they are performed, deliver accurate,
reliable and timely patient results.  In
2008, the FDA, which determines what tests are eligible for waiver, established
more stringent guidelines for in-vitro diagnostics to make certain that only
accurate and easy-to-use tests reach the physicians office.   In order for a device to be considered for waiver,
manufacturers must demonstrate that it is accurate and simple to use in a
CLIA-waived environment.  Testing,
moreover, must be performed by the intended user-for instance, a nurse, medical
assistant, or doctor-as opposed to a specially trained laboratory
technologist. 

After multiple studies to validate the test and considerable
collaboration with the FDA, the Alere™ Influenza Test has been granted waived
status. “We are very pleased to receive the CLIA waiver for the new Alere™
Influenza Test,” said Avi Pelossof, Vice President Infectious Diseaseat Alere
Inc. “By getting this product into the waived segment of the marketplace, we
are giving healthcare providers a new tool that will enable them to make better
decisions about flu diagnosis and treatment while patients are still in the
office.”

TheAlere™ Influenza A&B Test uses highly sensitive
antibodies to detect influenza types A and B antigen.  When compared to viral culture, the new Alere
testshowed performance with sensitivity / specificity of 93.8% / 95.8% for flu
A and 77.4% / 98% for flu B.Sample collection for the Alere™ Influenza A&B
Test, which makes use of a nasal swab,is minimally invasive.The testalso provides
results in 10 minutes, making it possible for physicians to administer treatment
while patients are still in their care.

The Alere™ Influenza A&B Test adds a dipstick format
test to Aleres existing portfolio of influenza diagnostics, which includes the
card format BinaxNOW® Influenza A&B Test,enabling Alere to provide primary
care physicians with a full range of easy-to-use, effective tools for
identifying influenza A & B at the point of care.

“Alere is dedicated to ensuring that only the highest
quality products reach the hands of healthcare providers,” stated Pelossof. “And
the Alere™ Influenza A&B Test is one of them.”

About Alere™

By developing new capabilities in near-patient diagnosis, monitoring and health
management, Alere enables individuals to take charge of improving their health
and quality of life at home. Aleres global leading products and services, as
well as its new product development efforts, focus on cardiology, women’s
health, infectious disease, oncology and toxicology. Alere is headquartered in Waltham, Massachusetts.  For more information regarding Alere please
visit www.Alere.com