US FDA clears Thermo Fisher’s tests for wheat and sesame allergy

ImmunoCAP Specific IgE Allergen Components for wheat and sesame allergies are soon to be available in the US

Thermo Fisher Scientific has announced the clearance of ImmunoCAP Specific IgE (sIgE) Allergen Components for wheat and sesame allergies by the US Food & Drug Administration (FDA) for in vitro diagnostic use. Soon to be available nationwide, these advanced blood tests can act as a diagnostic aid, helping specialists and other healthcare providers identify wheat and sesame allergies for patients at risk for a severe allergic reaction.

ImmunoCAP Specific IgE Allergen Component Ses i 1 provides a quantitative measurement of sIgE antibodies through a simple blood draw to help improve the diagnosis of sesame seed allergy. The test offers higher clinical specificity than skin prick testing extracts and whole allergen in-vitro sIgE sesame tests. Results can help identify patients with sesame allergy at risk for severe anaphylactic reaction and ultimately achieve better outcomes and patient management.

“Wheat is the third most common food allergy, but it’s often misdiagnosed and confused with other digestive disorders like gluten intolerance and celiac disease,” said Rebecca Rosenberger, MMSc, PA-C, Allergy Diagnostic & Treatment Center and Associate Director, Clinical Affairs & Education at Thermo Fisher Scientific. “ImmunoCAP Specific IgE Allergen Components for wheat help clinicians pinpoint true allergies and distinguish between wheat sensitization and grass cross-reactivity. This can prevent unnecessary diet restrictions for many patients.”

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