FDA clears first blood test for identifying a novel allergic sensitization to red meat
Thermo Fisher Scientific’s ImmunoCAP Specific IgE alpha-Gal Allergen Component test has been cleared by the U.S. Food & Drug Administration (FDA) for in vitro diagnostic use.
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 his or her risk for an anaphylactic reaction.
ImmunoCAP Specific IgE blood testing is the most widely used specific IgE blood test, and its use is documented in more than 6,000 peer-reviewed publications.
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.
According to the American Academy of Asthma, Allergy and Immunology, an allergy to alpha-Gal can cause patients to have a severe and potentially life-threatening reaction to galactose-alpha-1, 3-galactose that is found in most mammalian (red) meat.