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Food Allergy Diagnostics- Reducing Uncertainty 02 Nov 2023

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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.