Therapy Areas: AIDS & HIV
FDA Clears ImmunoCAP Blood Tests for Wheat and Sesame Allergy
17 August 2022 - - US-based scientific instrumentation, reagents and consumables, and software services provider Thermo Fisher Scientific's (NYSE: TMO) ImmunoCAP Specific IgE Allergen Components for wheat and sesame allergies has been cleared by the US Food and Drug Administration for in vitro diagnostic use, the company said.

Thermo Fisher said the blood tests, soon to be available nationwide, 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.

mmunoCAP 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.

ImmunoCAP Specific IgE Allergen Components for wheat measures IgE antibodies to Tri a 14 and Tri a 19 (omega-5-gliadin) components associated with severe reactions.

Results help confirm IgE-mediated wheat allergy as a cause of symptoms, help identify clinically irrelevant sensitizations due to grass cross-reactivity and improve avoidance recommendations.

ImmunoCAP blood testing is the most widely used sIgE test, with reference in more than 6,000 peer-reviewed publications.

The tests can identify allergic sensitization to common environmental allergens seasonal and perennial, indoor and outdoor as well as common food allergens such as peanuts, eggs, and milk.

ImmunoCAP tests, which are available in most major US laboratories and can be ordered for patients of any age regardless of skin condition, current medication, disease activity, or pregnancy status.


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