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Thermo Fisher Scientific Gets FDA Clearance for Red Meat Allergy Test

NEW YORK ─ Thermo Fisher Scientific said on Thursday that the US Food and Drug Administration has cleared its blood-based ImmunoCAP Specific IgE alpha-Gal Allergen Component test to detect a patient's sensitization to alpha-gal carbohydrate in red meat and assess the risk for an anaphylactic reaction.

Citing the American Academy of Asthma, Allergy, and Immunology, Waltham, Massachusetts-based Thermo Fisher said that an allergy to alpha-gal can cause patients to have a severe and potentially life-threatening reaction to galactose-alpha-1,3-galactose, which is found in most red meat.

Further, sensitization to the alpha-gal carbohydrate has been difficult to measure in patients.

"Skin-prick testing [for allergy] 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," said Lakiea Wright, medical director of US immunodiagnostics at Thermo Fisher. "Information from these tests can help providers be more precise in their diagnosis and management recommendations."