News Advisory
For Immediate Release
Product enquiries | Alere |
Media enquiries | Kelly Friend or Adrienne Walder, Alto Marketing Limited Tel: +44 (0) 1489 557 672 Email: kellyf@alto-marketing.comor adriennew@alto-marketing.com |
Waltham, Massachusetts (January 23, 2012) - Alere Inc. (NYSE:
ALR), 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 physician's 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 physician's 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 Disease at 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."
The Alere™ Influenza A&B Test uses highly sensitive
antibodies to detect influenza types A and B antigen. When
compared to viral culture, the new Alere test showed
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 test also 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
Alere's 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."
Alere product availability varies by region.
# # #
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. Alere's 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
distribué par | Ce noodl a été diffusé par Alere Inc.. Il a été distribué par noodls dans son format d'origine et sans modification sur 2012-01-23 18:40:16 PM et restera accessible depuis ce lien permanent. Cette annonce est protégée par les règles du droit d'auteur et toute autre loi applicable, et son propriétaire est seul responsable de sa véracité et de son originalité. |
Documents associés | |
Alere Rapid Flu Test Receives CLIA Waiver from FDA |