With the approval, the ImmunoCAP Specific IgE Allergen Components for wheat and sesame allergies will be commercially available in the US
Thermo Fisher has received FDA approval for its ImmunoCAP Specific IgE (sIgE) Allergen Components. (Credit: Tatiana from Pixabay)
Thermo Fisher Scientific has received the US Food and Drug Administration (FDA) approval for its ImmunoCAP Specific IgE (sIgE) Allergen Components for wheat and sesame allergies for in vitro diagnostic use.
The advanced blood tests, which will soon be offered nationally, can assist doctors and other healthcare professionals to identify wheat and sesame allergies in individuals with allergic reactions.
To aid in the accurate identification of sesame seed allergy, ImmunoCAP Specific IgE Allergen Component Ses i 1 offers a quantitative detection of sIgE antibodies through a quick blood draw.
According to the firm, the test gives higher clinical specificity in comparison to skin prick testing extracts and whole allergen in-vitro sIgE sesame tests
Results can help identify patients with sesame allergies who are at risk for a severe anaphylactic reaction, leading to better outcomes and patient management.
ImmunoCAP Specific IgE Allergen Components measures IgE antibodies to Tri a 14 and Tri a 19 (omega-5-gliadin) components linked to severe reactions.
The findings enhance avoidance advice by identifying clinically irrelevant sensitisations caused by grass cross-reactivity and confirming IgE-mediated wheat allergy as the source of symptoms.
Thermo Fisher Scientific Clinical Affairs & Education associate director Rebecca Rosenberger said: “Sesame was recently added to the top nine major food allergen list through the FASTER ACT because sesame reactions are often dangerous and unpredictable.
“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.”
The tests can detect allergic sensitisation to common food allergens like peanuts, eggs, and milk as well as seasonal, perennial, indoor, and outdoor allergens, said the company.
ImmunoCAP tests, which can be ordered by patients of any age regardless of age, skin condition, use of current medications, disease activity, or pregnancy status, are accessible in most US laboratories.