Bringing the Next Generation of Food Allergy Diagnostics Into the Clinic.

Food allergy diagnosis has a massive impact on the lives of patients and their families. Despite recent developments with specific IgE to component allergens, a significant proportion of patients assessed for possible food allergy require oral food challenge to ensure an accurate diagnosis. More precise diagnostic methods are required to reduce the need for oral food challenges. Bead-based epitope assays and cellular tests, such as basophil activation and mast cell tests are the most novel and promising tests on the horizon. There is a pathway to pursue to enable their incorporation in clinical practice, including standardization, technical validation, clinical validation, external validation, overcoming practical and logistical issues, and regulatory approval. Valuable clinical application of these tests goes beyond diagnosis and includes risk assessment to identify allergic patients who are most sensitive and at risk for severe allergic reactions, and to define prognosis and assess clinical response to immunomodulatory treatments.