July 23, 2020 – Thermo Fisher Scientific (Boston, MA) announced that the ImmunoCAP Specific IgE alpha-Gal Allergen Component test was cleared by the U.S. Food & Drug Administration (FDA) for in vitro diagnostic use. The company says that the test results can aid specialists and other healthcare providers as they diagnose a patient’s sensitization to the alpha-Gal carbohydrate found in mammalian (red) meat and assess the patient’s risk for an anaphylactic reaction.
ImmunoCAP Specific IgE blood testing is the most widely used specific IgE blood test, the company says. The tests can help identify allergic sensitization to common environmental allergens – seasonal and perennial, outdoor and indoor– as well as common food allergens such as peanut, egg and milk.
The ImmunoCAP Specific IgE Stinging Insect Allergen Component tests were recently cleared by the FDA to help improve the diagnosis of bee and wasp allergies. ImmunoCAP Specific IgE blood tests, which are available in most major U.S. laboratories, can be ordered for patients of any age regardless of skin condition, current medication, disease activity or pregnancy status.