Multiplex food allergy diagnostic based on IgE immunologic markers

基于 IgE 免疫标记物的多重食物过敏诊断

• 批准号: 10011621
• 负责人: David Seftel
• 金额: $ 84.58万
• 依托单位: ENABLE BIOSCIENCES, INC.
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-08 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10011621
• 关键词: Achievement; Affect; Agglutination; Agreement; Allergens; Allergic; Automation; Biological Assay; Biological Sciences; Blood; Blood Tests; Blood Volume; Blood specimen; Businesses; Cashew nut; Certification; Chemistry; Child; Childhood; Clinical; Clinical Trials; DNA; Development; Devices; Diagnosis; Diagnostic; Ensure; Evaluation; Exhibits; Food; Food Hypersensitivity; Generations; Hazelnuts; Health; Home environment; Hypersensitivity; IgE; Immunologic Markers; Immunologic Tests; Immunology; Immunotherapy; Infant; Juglans; Laboratories; Liquid substance; Manuals; Marketing; Measures; Methods; Milk; Monitoring Clinical Trials; Output; Patients; Performance; Phase; Plasma; Prevention; Prevention therapy; Process; Protocols documentation; Quality Control; ROC Curve; Reagent; Reproducibility; Risk; Robotics; Sampling; San Francisco; Secure; Sensitivity and Specificity; Shrimp; Signal Transduction; Specificity; Spottings; Technology; Test Result; Testing; Therapeutic; Transportation; United States; Validation; Variant; Venous; Venous blood sampling; Wheat; assay development; base; clinical trial enrollment; cohort; commercialization; cost; cross reactivity; design; egg; food allergen; food avoidance; improved; innovation; manufacturing process; next generation; novel; phase 1 study; product development; quality assurance; research clinical testing; software development; soy; success; testing services

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.

食物过敏是目前严重且日益严重的健康问题，影响了8％的儿童 我们。基于免疫学标志物IgE的血液检查促进食物过敏风险的评估， 并需要推荐避免食物或实施新的和创新的 免疫疗法。但是，过敏血液测试的当前方法很昂贵，需要 大量的静脉切开术，通常会导致误报和负面因素。在我们的阶段研究中， 启用生物科学创建了一个高度新颖的过敏免疫测试，基于同种型特异性 凝集-PCR（ISAP）技术。此ISAP过敏面板可检测到超过80％的普通 食物过敏原，包括花生，鸡蛋，牛奶，榛子，腰果和虾。与现有不同 方法，ISAP仅需要单个微量的血液才能执行，从而促进更轻松的测试 可能无法忍受大量血液的孩子。 ISAP显示100％特异性，并且 与38-60％的现有方法相比，所有食物过敏原的敏感性为75-100％ 特异性和71-96％的敏感性，使ISAP有可能大大减少误报和 过敏测试中的负面因素。 ISAP还显示出非常低的间和内分析变异性 （<15％）。最后，我们证明了ISAP可以适用于与干血点一起使用 与等离子体的完美相关性（r = 0.90-0.99）。以这些重要的技术为基础 成就，Enable已确保了与汉密尔顿机器人技术的关键业务合作伙伴关系 为ISAP分析提供营销和自动化支持。我们正处于克里亚的最后阶段 我们南旧金山实验室的认证，创建了一个新的临床测试渠道 ISAP测试的商业化。在此第二阶段提案中，我们寻求支持进一步的产品 开发和质量控制工作以优化临床市场的ISAP测试。 首先，我们将扩大目前的食物过敏面板，以覆盖所有常见的食物过敏原的95％。 其次，我们将自动化ISAP化学以降低人工成本并进一步改善 可重复性。第三，我们将生成和验证质量控制和制造协议 确保无缝可扩展性。最后，我们将验证ISAP用于干燥的适用性 血点样品可以减少侵入性测试。这个第二阶段的建议可以 通过增加可访问性，彻底改变过敏测试并使治疗成功取得成功 准确性和可重复性，同时降低患者和付款人的成本。