FDA Clears First Blood Test for Identifying a Novel Allergic Sensitization to Red Meat

PORTAGE, MI — July 23, 2020— ImmunoCAP Specific IgE alpha-Gal Allergen Component test has been cleared by the US Food & Drug Administration (FDA) for in vitro diagnostic use. Test results can aid specialists and other health care 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.

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. Unlike other food allergies, reactions from eating red meat may be delayed, occurring three to eight hours after eating. Symptoms range from hives and itching, to abdominal pain, nausea, or vomiting. In severe cases the allergy can cause anaphylaxis which can be potentially fatal. The condition can appear in patients who have tolerated meat for many years, with researchers believing that sensitization to alpha-Gal may be the result of a bite from the lone star tick (Amblyomma americanum).

“Alpha-gal is dramatically different from other forms of food allergy,” said Thomas Platts-Mills, MD, professor of medicine and microbiology at the University of Virginia School of Medicine and a leading researcher on the topic.  “Previously healthy adults can suddenly develop potentially life-threatening reactions to red meats such as beef, pork, and lamb.  The delayed nature of the reactions adds to the difficulty that clinicians and patients have in identifying the cause of the symptoms.  This unique set of circumstances makes an accurate diagnosis critical for managing this disease.”

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 US laboratories, can be ordered for patients of any age regardless of skin condition, current medication, disease activity, or pregnancy status.

“Sensitization to the alpha-Gal carbohydrate has been notoriously difficult to measure in patients,” said Dr. Lakiea Wright, MD MAT MPH, medical director, US ImmunoDiagnostics at Thermo Fisher Scientific. “Skin prick testing to red meats such as beef, pork, or lamb often gives weak or negative results, which is why, based on clinical studies, quantification of IgE antibodies to alpha-Gal in the blood is the preferred diagnostic method. Information from these tests can help providers be more precise in their diagnosis and management recommendations.” 

For more information on testing for alpha-Gal allergy, symptoms, and diagnosis, please visit allergyinsider.com.