Multiplex food allergy diagnostic based on IgE immunologic markers

食物过敏是一个严重且日益严重的健康问题，目前影响着中国8%的儿童 我们。基于免疫学标记IgE的血液测试有助于评估食物过敏风险， 并被要求建议避免食物或实施新的和创新的 免疫疗法。然而，目前的过敏性血液检测方法昂贵，需要 大量静脉采血，常导致假阳性和假阴性。在我们的第一阶段研究中， Enable Biosciences创造了一种基于同型特异性的高度新颖的过敏免疫测试 凝集聚合酶链式反应(ISAP)技术。这个ISAP过敏小组检测到超过80%的常见 食物过敏原，包括花生、鸡蛋、牛奶、榛子、腰果和虾。与现有的不同 方法，ISAP只需要一微升的血液就可以进行，从而使检测更容易 可能无法忍受大量抽血的儿童。ISAP显示100%的特异性和 与现有方法相比，对所有食物过敏原的灵敏度为75%-100%，而现有方法的灵敏度为38%-60% 特异性和71%-96%的敏感性，使ISAP有可能极大地减少假阳性和 过敏测试呈阴性。ISAP还显示出极低的分析间和分析内变异性 (&lt；15%)。最后，我们演示了ISAP可用于干血斑和 与血浆接近完全相关(R=0.90~0.99)。以这些重要的技术为基础 成就，Enable与汉密尔顿机器人公司建立了关键的业务合作伙伴关系，以 为ISAP检测提供市场和自动化支持。我们正处于CLIA的最后阶段 为我们的南旧金山实验室提供认证，为 ISAP测试的商业化。在此第二阶段提案中，我们寻求对更多产品的支持 致力于为临床市场优化ISAP测试的开发和质量控制。 首先，我们将扩大我们目前的食物过敏专门小组，以涵盖所有常见食物过敏原的95%。 第二，我们将使ISAP化学过程自动化，以降低人工成本并进一步提高 再现性。第三，我们将生成并验证质量控制和制造协议 以确保无缝可伸缩性。最后，我们将验证ISAP是否适合与SDED一起使用 血斑样本允许进行更少的侵入性测试。此第二阶段提案可以 通过提高可获得性，使过敏测试发生革命性变化，并实现治疗成功， 准确性和重复性，同时降低患者和付款人的成本。

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.