Portage, MI —August 16, 2011—Today Phadia, the global leader in allergy and autoimmune disease-related diagnostics, announced that the uKnow Peanut Test, its peanut allergen component test, is now commercially available in the United States through the Phadia Immunology Reference Laboratory (PiRL®). FDA clearance of the individual peanut component tests, announced in May 2011, brings these cutting-edge new in vitro allergy tests to clinicians nationwide. The uKnow Peanut Test reports specific IgE results to five FDA cleared peanut allergen components in addition to carbohydrate cross-reactive determinants, a laboratory developed test.
Severe peanut allergies can cause fatal anaphylactic reactions. As a result, every parent fears the possibility that their child will be diagnosed with peanut allergy, envisioning the life-threatening nature of the allergy and the significant dietary and other restrictions required to keep their children safe. With the uKnow Peanut Test, physicians can now detect the allergic sensitization to the specific allergen components within the whole peanut to help assess the risk that a patient will experience a severe anaphylactic reaction upon exposure to peanut.
Current literature available on peanut allergy points to the protein Ara h 2 as one of the key culprits in producing anaphylaxis. Sensitization to some other proteins within the peanut may not be as relevant to the risk of more severe allergic reactions. In addition, symptoms due to cross-reactivity to allergens such as birch pollen can often mimic sensitization to peanut when traditional diagnostic testing using the whole peanut extract is performed. A study published last year in the Journal of Allergy and Clinical Immunology (Custovic, et.al.) estimated that nearly 80 percent of children diagnosed with peanut allergy were not truly allergic. In the study, results from Phadia’s peanut allergen component tests were 95 percent correlated to an allergic reaction.
David Esposito, President and General Manager of Phadia US, said, “Peanut allergy is an emotionally-charged issue that strikes fear in the hearts of parents, patients, school administrators and school nurses alike. With the introduction of the uKnow Peanut Test, Phadia is equipping clinicians with the ability to more accurately diagnose their patients’ likely reaction to peanut exposure. Armed with this knowledge, the patient and physician together can make a more informed assessment and decide on an appropriate management plan. With commercial availability of the uKnow Peanut Test, we expect that many patients who were previously diagnosed with peanut allergy will now be given additional information at the molecular level to better assess their lifestyle and management choices.”
The uKnow Peanut Test will be available exclusively through PiRL. This launch will provide Phadia with the ability to aggregate national data on peanut allergy, and support the broad assessment and interpretation of peanut component results across all regions of the country.
Physicians and patients can learn more about the uKnow Peanut Test at www.uKnowPeanut.com or call 1-800.346.4364, Option 1. Laboratory customers can access the uKnow Peanut Test through a reference agreement with PiRL.
Phadia first introduced allergen component testing in the United States in 1990, when ImmunoCAP® Allergen Component tests for milk were cleared by the FDA. This was followed by the FDA clearance of egg components in 1998. The FDA clearance announced in May 2011 included 13 additional components including those found in peanut, cat dander, dust mite, bermuda grass, ragweed and the mold Alternaria alternata. Additional allergy test packages are currently under review by the FDA.
ImmunoCAP is the world’s leading component blood test. ImmunoCAP Allergen Components have been used in the European market for over 30 years. ImmunoCAP® specific IgE blood tests are the assay of choice among specialists, referenced and supported in over 4,000 scientific publications. In Europe, use of ImmunoCAP Allergen Components is common to help parents of children with suspected food allergies, policy makers, and school officials, who are desperate for additional clarity on food allergies.
Phadia AB is a global leader in allergy, asthma and autoimmunity diagnostics. Phadia develops, manufactures, and markets complete blood test systems to manage and support clinical diagnosis of allergy and autoimmune-related diseases. Phadia has marketing companies in more than 20 countries and distributors in more than 60 countries. For more information please visit www.phadia.com