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Thermo Fisher Scientific Gets FDA Clearance for Insect Sting Sensitization Test Components


NEW YORK — Thermo Fisher Scientific said on Monday that it has received US Food and Drug Administration clearance for its ImmunoCAP Specific IgE Stinging Insect Allergen Components for the identification of insect sting sensitivity.

Thermo Fisher's ImmunoCAP assays are designed to detect immunoglobulin E in order to identify allergic sensitization to environmental, food, and animal allergens. The ImmunoCAP Specific IgE Stinging Insect Allergen Components analyze sensitivity to up to eight different proteins found in bee and wasp venom, according to the Waltham, Massachusetts-based company.

"People who have experienced an allergic reaction to an insect sting have a 60 percent chance of a similar or worse reaction if stung again," Lakiea Wright, medical director of US clinical affairs at Thermo Fisher, said in a statement. "Testing a patient's sensitization to venom proteins may play a critical role in helping clinicians devise plans for future therapy."

In early 2019, Thermo Fisher received FDA clearance for its ImmunoCAP Specific IgE blood test for the Ara h6 protein component in peanuts. Thermo Fisher said it also recently received FDA clearance for the ImmunoCAP Specific IgE Pet Allergen Components for the diagnosis of dog, cat, and horse allergies.