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Rebecca Lumley
18 Aug 2022

FDA approves Thermo Fisher blood tests for wheat and sesame allergies

Both tests have been approved by the US regulator for in vitro diagnostic use  

The US Food and Drug Administration (FDA) has approved advanced blood tests created by Thermo Fisher Scientific that act as diagnostic aids for healthcare providers to identify wheat and sesame allergies for patients at risk of severe allergic reaction.

Thermo Fisher’s ImmunoCAP Specific IgE (sIgE) Allergen Components for wheat and sesame were approved by the US regulator for in vitro diagnostic use.  

ImmunoCAP Specific IgE Allergen Component Ses i I, which is used to diagnose sesame seed allergies, works by providing a quantitative measurement of sIgE antibodies through a simple blood draw, while 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. 

‘Sesame was recently added to the top nine major food allergen list through the FASTER ACT because sesame reactions are often dangerous and unpredictable,’ said Rebecca Rosenberger, MMSc, PA-C, Allergy Diagnostic & Treatment Center and Associate Director, Clinical Affairs & Education at Thermo Fisher Scientific.  

‘Sesame is often a hidden allergen making the danger of accidental intake even greater. ImmunoCAP Specific IgE Allergen Component for sesame provides clinicians with a more complete assessment of the patient’s allergy. 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.’ 

ImmunoCAP blood testing is the most widely used sIgE test and is referenced in more than 6,000 peer-reviewed publications. The tests can identify allergic sensitization to common environmental allergens as well as common food allergens such as peanuts, eggs, and milk. 

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