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3/28/2001
FDA Accepts ImmunoCAP® Allergy Blood Test for Quantitation

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.DoIHaveAllergies.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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