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FDA Accepts ImmunoCAP® Allergy
Blood Test for Quantitation
03/28/2001
KALAMAZOO, Mich., March 28 -- Pharmacia Diagnostics today
announced that the ImmunoCAP Allergy Blood Test became the
first and only allergy test to be accepted as a truly quantitative
test by the United States Food and Drug Administration (FDA).
For the first time, it is possible to measure with unprecedented
accuracy an individual's sensitivity to a given allergen
using ImmunoCAP. This information can help clinicians better
manage the
50 million Americans who suffer from allergies
and allergy-like symptoms.
"This signifies a major advance in the evolution of
blood allergy technology," said Brock Williams, PhD,
Clinical Research Professor at Children's Mercy Hospital
in Kansas City, Missouri, and a leading allergy and diagnostics
expert. "It provides a new benchmark for accuracy and
reliability, and allows clinicians to assess an individual's
reaction to specific food and environmental allergens, and
to tailor treatment strategies appropriately."
With a small blood sample taken in a physician's office
and analyzed in a laboratory, patients and physicians can
learn the cause of suspected allergic symptoms. ImmunoCAP
measures the amount of IgE, an antibody circulating in the
blood when the body is fighting an allergen. Extensive data
has been generated that demonstrates that ImmunoCAP data
meets several performance criteria, including an international
reference calibrator and accuracy and precision data. ImmunoCAP
also demonstrates patient sensitivity to specific allergens
by reporting the number of Kilo-units per liter (kUA/L),
where the "A" represents the amount of specific
IgE antibody present in the blood.
The Evolution of In Vitro Allergy Diagnosis
Allergy testing has traditionally been performed by allergy specialists applying
allergens directly to or under the skin, with a raised welt indicating sensitivity.
However, skin testing carries the risk of serious allergic reaction, is not
recommended for young children and seniors, and is not readily available
to non-specialists. As a result, in vitro tests that can be used in all physicians'
offices were developed.
A recent study, published in the June issue of the Journal
of Allergy and Clinical Immunology, demonstrated ImmunoCAP
technology's superior reliability and accuracy compared to
four other serologic tests, including the older RAST™ blood
test. "Other tests including the still-used, older RAST
technology produce less accurate results," said Dr.
Williams.
"We're delighted by the FDA's recognition of ImmunoCAP
as a quantitative diagnostic system," said Robert Reinhardt,
MD, U.S. Medical Director at Pharmacia Diagnostics. "The
application of this state-of-the-art yet easy-to-use technology
can positively impact allergy-like symptom management for
patients."
Strong Clinical Utility
Because allergy-like symptoms can be caused by a number of medical conditions,
including bacterial infection or viral infection, it is important to have
a simple, effective way to differentiate between atopy and other upper respiratory
diseases. Once allergy is determined to be the cause of the symptoms, strategies
to manage the offending culprits begin and quantitative information about
allergens can be helpful.
Allergy is often referred to as a threshold disease, meaning
that individuals can be allergic to one or many things, but
may not exhibit symptoms until they are exposed to enough
allergic triggers to put them "over the top." Sometimes
treatment is as simple as taking an allergic trigger out
of a patient's environment - particularly one to which he/she
is highly allergic.
"An accurate quantitation of antibodies can help clinicians
identify the major allergens that are causing symptoms and
thus provide tools for keeping a patient under his/her allergic
threshold, either by avoidance or medical therapy," said
Dr. Williams. Consumers and health professionals with questions
about ImmunoCAP or the role of diagnostic quantitation can
call 1-877-862-4948 or visit www.isitallergy.com for additional
information.
Pharmacia Diagnostics, a division of Pharmacia Corporation,
is headquartered in Uppsala, Sweden, and is a world leader
in in vitro diagnostic research and product innovation. The
U.S. headquarters for Pharmacia Diagnostics is in Kalamazoo,
Michigan.
Pharmacia Corporation (NYSE: PHA) is a leading global pharmaceutical
company created through the merger of Pharmacia & Upjohn
with Monsanto Company and its G.D. Searle unit. Pharmacia
has a broad product portfolio, a robust pipeline of new medicines,
and an annual investment of more than $2 billion in pharmaceutical
research and development.
SOURCE: Pharmacia Corporation
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