Thermo Fisher Scientific has secured approval from the US Food & Drug Administration (FDA) for in vitro diagnostic use of its blood test to detect a novel allergic sensitisation to red meat.
The ImmunoCAP Specific IgE alpha-Gal Allergen Component test has been approved to help specialists and other healthcare providers to diagnose a patient’s sensitisation to the alpha-Gal carbohydrate found in mammalian (red) meat and evaluate the patient’s risk for an anaphylactic reaction.
The ImmunoCAP Specific IgE blood testing will help detect allergic sensitisation to common environmental allergens such as seasonal and perennial, outdoor and indoor, in addition to common food allergens such as peanut, egg and milk.
Thermo Fisher also offers FDA-approved ImmunoCAP Specific IgE Stinging Insect Allergen Component tests
According to the company, the ImmunoCAP Specific IgE Stinging Insect Allergen Component tests have been recently approved by the FDA to advance the diagnosis of bee and wasp allergies.
ImmunoCAP Specific IgE blood tests, which are available in most large US laboratories, can be used for patients of any age irrespective of skin condition, current medication, disease activity or pregnancy status.
Thermo Fisher Scientific US immunodiagnostics medical director Dr Lakiea Wright said: “Skin prick testing to red meats such as beef, pork, or lamb often gives weak or negative results, which is why, based on clinical studies, quantification of IgE antibodies to alpha-Gal in the blood is the preferred diagnostic method.
“Information from these tests can help providers be more precise in their diagnosis and management recommendations.”
In June this year, Thermo Fisher Scientific agreed to expand its partnership with Daiichi Sankyo to co-develop a companion diagnostic (CDx) to identify non-small cell lung cancer (NSCLC).
The co-developed CDx is aimed at identifying NSCLC in patients with human epidermal growth factor receptor 2 (HER2) mutations who may be eligible for Enhertu.
