Food allergy is a serious and growing health concern currently affecting 8% of children in the US. Blood tests based on the immunology marker IgE facilitate assessment of food allergy risks, and are required to recommend food avoidance or to implement new and innovative immunotherapies. However, current methods for allergy blood testing are expensive, require large volume phlebotomy and often result in false positives and negatives. In our Phase I study, Enable Biosciences created a highly novel allergy immune test based on Isotype-Specific Agglutination-PCR (ISAP) technology. This ISAP allergy panel detects over 80% of common food allergens, including peanut, egg, milk, hazelnut, cashew, and shrimp. Unlike existing methods, ISAP requires only a single microliter of blood to perform, facilitating easier testing in children who may not be able to endure large blood draws. ISAP displayed 100% specificity and 75-100% sensitivity for all food allergens in comparison to existing methods that exhibit 38-60% specificity and 71-96% sensitivity, giving ISAP the potential to greatly reduce false positives and negatives in allergy testing. ISAP also showed very low inter- and intra- assay variability (<15%). Finally, we demonstrated that ISAP can be adapted for use with dried blood spot with near perfect correlation with plasma (R = 0.90-0.99). Building upon these significant technical achievements, Enable has secured pivotal business partnerships with Hamilton Robotics to provide marketing and automation support for ISAP assays. We are in the final stage of CLIA certification for our South San Francisco laboratory, creating a new clinical testing channel for commercialization of ISAP tests. In this Phase II proposal, we seek support for further product development and quality control efforts to optimize ISAP testing for the clinical marketplace. First, we will expand our current food allergy panels to cover 95% of all common food allergens. Second, we will automate the ISAP chemistry to reduce labor costs and further improve reproducibility. Third, we will generate and validate quality control and manufacturing protocols to ensure seamless scalability. Finally, we will validate the suitability of ISAP for use with dried blood spot samples to permit even less invasive testing. This Phase II proposal can revolutionize allergy testing and enable therapeutic success by increasing accessibility, accuracy and reproducibility while reducing costs for patients and payors alike.

Public Health Relevance

Food allergy is a growing and potentially fatal condition affecting over 8% of children in the United States. Tests that diagnose or establish risk for allergy guide treatment decisions and support clinical trials for new and innovative prevention therapies. However, current allergy tests are expensive, inaccurate and require large volumes of blood which makes it challenging to test small children. Enable Biosciences is developing a low-cost, next-generation allergy test with much better accuracy that requires only a minute blood sample that can be collected by fingerstick or dried blood spot in the convenience of the home.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
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Special Emphasis Panel (ZRG1)
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Minnicozzi, Michael
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Enable Biosciences, Inc.
South San Francisco
United States
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