Challenging Times for Food Allergy Diagnostics


In this inNews, we focus on recent recalls of diagnostic food allergen extracts, first with peanut and now with pecan. The recalled extracts gave false negative reactions on skin testing and resulted in food allergic patients having adverse reactions, including life-threatening anaphylaxis, on consuming the food.

The US FDA issued a Warning of potential anaphylaxis following false negative skin tests to food extracts in March. Reasons for the recalls have not been disclosed. Without better understanding, it is unclear what steps are being taken to prevent this happening again. This creates uncertainty and anxiety for food allergic patients and poses challenges for allergists and healthcare providers. What to advise following negative skin tests?

What is clear is that there is an urgent need for standardization of food allergen extracts. Despite the huge increase in research on food allergens over the past 20 years, regulatory authorities have largely ignored food allergens, which remain unstandardized. At the same time, the tools available for standardization have never been better.

InBio’s multi-faceted approach to allergen standardization is featured below. Other approaches to producing standardized food allergen extracts with defined allergen content should also be considered. The goal is to produce reliable food standards of defined potency to reduce the risks of adverse reactions for food allergic patients.

InBio is hosting a webinar to discuss the food allergen recalls, together with recent advances in molecular diagnostics and standardization on November, 2nd, 2023 at 10am EDT.

We hope that you can join us.

Martin Chapman

President & CEO, InBio

Food Allergy Diagnostics- Reducing Uncertainty

Thursday, November 2nd at 10am EDT

Register here

Recent reports of false negative reactions upon skin testing with diagnostic food allergens raise serious concerns for food allergic patients and their health care providers. In December 2022, ALK-Abelló, the world’s largest allergen manufacturer, voluntarily recalled 4 lots of peanut extract that gave false negative reactions on skin testing and were associated with adverse events, including life-threatening anaphylaxis. In March, the U.S. Food and Drug Administration introduced safety labeling changes for all diagnostic food allergenic extracts including a Warning of anaphylaxis following false negative skin tests.

The FDA Warning proved to be profound. In September, ALK-Abelló voluntarily withdrew one lot of diagnostic pecan extract following false negative skin test results associated with adverse events including one case of life-threatening anaphylaxis.

Collaborative studies with Drs. Cosby Stone and Scott Smith (Vanderbilt University) and Jonathan Hemler (University of Virginia) showed significant differences between recall and non-recall lots of the diagnostic peanut extracts. The recall lots contained negligible amounts of major peanut allergens by either InBio murine mAb ELISA or using human IgE mAb ELISA. These studies underscore the value of measuring specific allergens for quality control and standardization purposes.

There is an urgent need for standardization of food allergen extracts. Over the past 25 years, InBio has developed a multi-faceted approach to allergen standardization which includes biochemical methods, immunoassays, mass spectrometry and human IgE monoclonal antibodies.

Join InBio scientists to discuss the food allergen recalls, as well as recent advances in molecular diagnostics and standardization on Thursday, November 2nd at 10am EDT. Register here.


Learning Objectives:

  • Understand the significance behind the food extract recalls.
  • Understand the multi-faceted approach in allergen standardization.
  • Discuss the latest research on InBio’s exclusive product, human IgE monoclonal antibodies.

When: Thursday, November 2nd, 2023 10am EDT.

We hope that you can join us and attend the webinar. There will be plenty of opportunity for discussion in the Q&A. Please contact Beattie Sturgill with any questions or comments. Register here.

InBio’s Multi-faceted Approach to Allergen Standardization

The multi-faceted approach includes:

  • Biochemical analyses
  • Immunoassays for precise measurement of specific allergens;
  • Mass spectrometry for detecting multiple allergens
  • Human IgE monoclonal antibodies from allergic patients
  • Customized methods for novel therapeutic products
  • Standardization based on measuring allergens- the active pharmaceutical ingredients (API)

The combined use of biochemical methods, immunoassaysmass spectrometry and human IgE monoclonal antibodies can be used for allergen standardization. Cellular tests such as the basophil activation test or mediator release assays could also be part of the approach. The protocol for MARIA® for Foods has just been published.While some food allergen reference materials are available, almost invariably these materials have not been tested for specific allergens. InBio recently published allergen levels in NIST and MoniQA food references. InBio will also be presenting data on peanut, hazelnut, and pistachio flour protein reference materials, including specific allergen composition, at the upcoming webinar.
Pairs of human IgE mAb elicit mediator release from a humanized rat basophilic cells line (huRBL) when cross linked by allergen (Der p 2, Fel d 1, Ara h 2, Ara h 6). InBio has just published data on 33 hIgE mAb to indoor allergens and food allergens derived from patients with asthma, atopic dermatitis, EOE and food allergy. Strikingly, ~60% of the hIgE mAb were derived from young children (aged 3-10).

Smith et al: Unique allergen specific human IgE monoclonal antibodies derived from patients with allergic disease. Front Allergy 2023 in press. DOI: 10.3389/falgy.2023.1270326

Let’s Work Together

Whether you conduct primary research on allergens, develop diagnostic systems, or create products to alleviate environmental and food allergies, you need expertise in action. And that’s exactly what InBio delivers, across everything from highly purified allergens and advanced test kits, to environmental and food allergen testing, to contract research for specialized needs.

  • Broad product catalog
  • Deep scientific background
  • Ongoing commitment to R&D
  • Well-documented subject-matter expertise
  • Direct contact with our scientific team
  • Flexible, collaborative relationships

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