Bringing the Next Generation of Food Allergy Diagnostics Into the Clinic

Abstract

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. 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. Information for Category 1 CME CreditCredit can now be obtained, free for a limited time, by reading the review articles in this issue. Please note the following instructions.Method of Physician Participation in Learning Process: The core material for these activities can be read in this issue of the Journal or online at the JACI: In Practice Web site: www.jaci-inpractice.org/. The accompanying tests may only be submitted online at www.jaci-inpractice.org/. Fax or other copies will not be accepted.Date of Original Release: January 1, 2022. Credit may be obtained for these courses until December 31, 2022.Copyright Statement: Copyright © 2022-2024. All rights reserved.Overall Purpose/Goal: To provide excellent reviews on key aspects of allergic disease to those who research, treat, or manage allergic disease.Target Audience: Physicians and researchers within the field of allergic disease.Accreditation/Provider Statements and Credit Designation: The American Academy of Allergy, Asthma & Immunology (AAAAI) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. The AAAAI designates this journal-based CME activity for 1.00 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.List of Design Committee Members: Alexandra F. Santos, MD, PhD, Michael D. Kulis, PhD, and Hugh A. Sampson, MD (authors); Scott H. Sicherer, MD (editor)Learning objectives:1.To describe the principles of the basophil activation test (BAT) and mast cell activation test (MAT) and the determination of IgE to allergen epitopes.2.To explain the diagnostic performance of the BAT and MAT and IgE to allergen epitopes in food allergy.3.To describe the added value of the BAT and IgE to allergen epitopes to tests currently used in routine clinical practice.Recognition of Commercial Support: This CME has not received external commercial support.Disclosure of Relevant Financial Relationships with Commercial Interests: A. F. Santos reports grants and personal fees from Medical Research Council (MR/M008517/1; MR/T032081/1); reports grants from Food Allergy Research and Education (FARE), Asthma UK and the National Institute for Health Research (NIHR) through the Biomedical Research Centre (BRC) award to Guy's and St Thomas' NHS Foundation Trust and the Immune Tolerance Network/National Institute of Allergy and Infectious Diseases (NIH/NIAID); reports consultancy fees from Thermo Scientific, Nutricia, Infomed, Novartis, Buhlmann, Allergy Therapeutics, Novartis, Iggenix, Stallergenes; and reports research support from Buhlmann and Thermo Scientific through a collaboration agreement with King's College London. M. Kulis reports funding through NIH/NIAID and the U.S. Department of Defense and consultancy fees from Ukko. H. A. Sampson receives funding to his institution for grants from the NIH/NIAID; reports consulting fees from DBV Technologies, S.A., N-Fold, LLC, and Siolta Therapeutic, Inc.; and reports stock options from DBV Technologies and N-Fold Therapeutics. The reviewer reported no relevant financial relationships. Credit can now be obtained, free for a limited time, by reading the review articles in this issue. Please note the following instructions. Method of Physician Participation in Learning Process: The core material for these activities can be read in this issue of the Journal or online at the JACI: In Practice Web site: www.jaci-inpractice.org/. The accompanying tests may only be submitted online at www.jaci-inpractice.org/. Fax or other copies will not be accepted. Date of Original Release: January 1, 2022. Credit may be obtained for these courses until December 31, 2022. Copyright Statement: Copyright © 2022-2024. All rights reserved. Overall Purpose/Goal: To provide excellent reviews on key aspects of allergic disease to those who research, treat, or manage allergic disease. Target Audience: Physicians and researchers within the field of allergic disease. Accreditation/Provider Statements and Credit Designation: The American Academy of Allergy, Asthma & Immunology (AAAAI) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. The AAAAI designates this journal-based CME activity for 1.00 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. List of Design Committee Members: Alexandra F. Santos, MD, PhD, Michael D. Kulis, PhD, and Hugh A. Sampson, MD (authors); Scott H. Sicherer, MD (editor) Learning objectives:1.To describe the principles of the basophil activation test (BAT) and mast cell activation test (MAT) and the determination of IgE to allergen epitopes.2.To explain the diagnostic performance of the BAT and MAT and IgE to allergen epitopes in food allergy.3.To describe the added value of the BAT and IgE to allergen epitopes to tests currently used in routine clinical practice. Recognition of Commercial Support: This CME has not received external commercial support. Disclosure of Relevant Financial Relationships with Commercial Interests: A. F. Santos reports grants and personal fees from Medical Research Council (MR/M008517/1; MR/T032081/1); reports grants from Food Allergy Research and Education (FARE), Asthma UK and the National Institute for Health Research (NIHR) through the Biomedical Research Centre (BRC) award to Guy's and St Thomas' NHS Foundation Trust and the Immune Tolerance Network/National Institute of Allergy and Infectious Diseases (NIH/NIAID); reports consultancy fees from Thermo Scientific, Nutricia, Infomed, Novartis, Buhlmann, Allergy Therapeutics, Novartis, Iggenix, Stallergenes; and reports research support from Buhlmann and Thermo Scientific through a collaboration agreement with King's College London. M. Kulis reports funding through NIH/NIAID and the U.S. Department of Defense and consultancy fees from Ukko. H. A. Sampson receives funding to his institution for grants from the NIH/NIAID; reports consulting fees from DBV Technologies, S.A., N-Fold, LLC, and Siolta Therapeutic, Inc.; and reports stock options from DBV Technologies and N-Fold Therapeutics. The reviewer reported no relevant financial relationships.

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