Thermo Fisher Scientific Receives FDA Clearance for New Allergen Component Tests for Hazelnut, Walnut and Cashew Nut IgE Sensitization

Thermo Fisher Scientific Inc., the world leader in serving science, has announced that it has received 510(K) clearance from the U.S. Food and Drug Administration (FDA) for five new ImmunoCAP Allergen Component tests for detecting IgE sensitization to hazelnut, walnut and cashew nut proteins (components). The tests are performed on Phadia Laboratory Systems.

ImmunoCAP Allergen Component tests measure a patient’s Immunoglobulin E (IgE) antibody sensitization (allergic sensitization) to individual tree nut proteins called allergen components. Quantifying a patient’s IgE sensitization to these allergen components can help clinicians identify primary nut sensitization and help differentiate it from sensitization due to cross-reactivity. A proper diagnosis can help the clinician develop a more comprehensive management plan.

The following component tests are now FDA-cleared:

• ImmunoCAP Allergen f439, Allergen component rCor a 14, Hazelnut and ImmunoCAP Allergen f440, Allergen component nCor a 9, Hazelnut. IgE antibodies to hazelnut storage proteins, Cor a 9 and Cor a 14, are suggestive of primary hazelnut allergic sensitization.
• ImmunoCAP Allergen f441, Allergen component rJug r 1, Walnut and ImmunoCAP Allergen f442, Allergen component rJug r 3, LTP, Walnut. IgE antibodies to walnut storage protein, Jug r 1, is suggestive of a primary walnut allergic sensitization while antibodies to Jug r 3, a lipid transfer protein (LTP), is suggestive of cross-reactivity with other LTP-containing foods.
• ImmunoCAP Allergen f443, Allergen component rAna o 3, Cashew Nut is a storage protein that is highly abundant in cashew nuts and associated with species-specific cashew allergic sensitization.