Case Study

Testing GMOs for Allergen Potential

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Challenge

GMOs (Genetically Modified Organisms) have the potential to vastly improve our food supply with products that are more nutritious, productive, sustainable or transportable. But new GMOs are subject to intensive regulatory review before they can hit the grocery store aisles.

In order to prove that a GMO is safe, Agroscience developers need to be able to prove that the new plant does not produce unexpected proteins that could induce an allergic response in susceptible individuals. To test for allergenic potential, developers need to be able to answer several questions: what proteins or peptides are produced as a result of the inserted genetic sequence? Are they different than those produced in the non-GMO/parent form of the organism? And if so, do they match any proteins known to produce an allergic response in humans? 

The Solution

Testing for potential allergens begins with a comprehensive analysis at the genetic level of the organism (by Sanger or NexGen sequencing chemistries or radiologic Southern blotting) to ensure the transgene has been incorporated or retained within the genome. Gene expression levels can be quantified by qPCR methodologies coupled with protein expression levels detected by standard or multiplex immunoassays. To determine the allergy risk potential, we use an advanced bioinformatics approach to compare the recombinant protein sequence against a comprehensive database of known allergens.
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The Outcome

Battelle provides accurate, defensible data to help support clients in the registration of their GMO products quickly and efficiently. Our labs are fully compliant with Good Laboratory Practice Standards (GLPS) to meet the most stringent requirements for U.S. or European product registration. Our advanced analytical, immunobiological and bioinformatic techniques provide developers with a complete nutritional profile as well as an allergy risk assessment. The final result? Farmers and consumers have access to safe, new food products that will meet the needs of the 21st century. 
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