title: Digestion assays in allergenicity assessment of transgenic proteins.
abstract: The food-allergy risk assessment for transgenic proteins expressed in crops is currently based on a weight-of-evidence approach that holistically considers multiple lines of evidence. This approach recognizes that no single test or property is known to distinguish allergens from nonallergens. The stability of a protein to digestion, as predicted by an in vitro simulated gastric fluid assay, currently is used as one element in the risk assessment process. A review of the literature on the use of the simulated gastric fluid assay to predict the allergenic status of proteins suggests that more extensive kinetic studies with well-characterized reference proteins are required before the predictive value of this assay can be adequately judged.
authors.affiliation: Dow AgroSciences LLC, Indianapolis, Indiana 46268, USA. raherman@dow.com
authors.forename: Rod A
authors.initials: RA
authors.lastname: Herman
authors.forename: Nicholas P
authors.initials: NP
authors.lastname: Storer
authors.forename: Yong
authors.initials: Y
authors.lastname: Gao
mesh_terms: D000818:Animals; D004044:Dietary Proteins / Q000009:adverse effects*; D004063:Digestion / Q000502:physiology*; D005512:Food Hypersensitivity / Q000503:physiopathology*; D030841:Food, Genetically Modified / Q000009:adverse effects*; D005753:Gastric Mucosa / Q000378:metabolism; D006801:Humans; D007700:Kinetics; D015203:Reproducibility of Results
chemical_list: D004044:Dietary Proteins