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Thermo Fisher Scientific Wheat, Sesame Allergy Tests Nab FDA Clearance

NEW YORK – Thermo Fisher Scientific announced on Wednesday that two of its ImmunoCap allergy tests have received clearance from the US Food and Drug Administration. 

The ImmunoCap Specific IgE Allergen Component Ses i 1 test quantitatively measures specific IgE antibodies to help identify patients with sesame allergies who are at risk for severe anaphylactic reactions. According to a statement from Thermo Fisher, the test "offers higher clinical specificity than skin prick testing extracts and whole allergen in vitro sIgE sesame tests." 

"ImmunoCAP Specific IgE Allergen Component for sesame provides clinicians with a more complete assessment of the patient’s allergy," Rebecca Rosenberger, associate director of clinical affairs and education at Thermo Fisher, said in the statement. "It also helps evaluate the risks associated with a severe systemic reaction (e.g., anaphylaxis) and to better qualify patients for an oral food challenge."

The ImmunoCap Specific IgE Allergen Components test for wheat measures IgE antibodies to Tri a 14 and Tri a 19 components of wheat allergens that are associated with severe reactions. The assay's results can help confirm that IgE-mediated wheat allergy is causing symptoms and improve avoidance recommendations, Thermo Fisher said. It can also distinguish between wheat sensitization and grass cross-reactivity, which can "prevent unnecessary diet restrictions for many patients," Rosenberger said. 

Both tests will soon be available nationwide, the company added.