# Multiplex food allergy diagnostic based on IgE immunologic markers

> **NIH NIH R44** · ENABLE BIOSCIENCES, INC. · 2021 · $644,600

## Abstract

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.

## Key facts

- **NIH application ID:** 10138935
- **Project number:** 5R44AI141118-03
- **Recipient organization:** ENABLE BIOSCIENCES, INC.
- **Principal Investigator:** David Seftel
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $644,600
- **Award type:** 5
- **Project period:** 2018-08-08 → 2023-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10138935

## Citation

> US National Institutes of Health, RePORTER application 10138935, Multiplex food allergy diagnostic based on IgE immunologic markers (5R44AI141118-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10138935. Licensed CC0.

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