Transforming oral food challenges for gold-standard food allergy diagnosis and management in young children

食物过敏(FA)患病率和住院率正在上升，特别是在幼儿中。患者及其家人可能会因过敏反应、社会排斥、生活质量下降和高额自付费用而死亡。新的治疗方法有望给FA带来革命性的变化，刺激对合作伙伴诊断的强劲需求。今天的金标准FA诊断是双盲、安慰剂控制的食物挑战(DBPCFC)。在这里，患者以递增的量摄入可疑的食物，直到观察到轻微的过敏反应与难以区分的低/零剂量控制挑战。然而，目前的测试是不盲目的、不准确的、可伸缩性差的和不安全的。这使得英国在未来几年面临脆弱的儿科患者所需的大量测试。Reacta Biotech已经为在受控条件下生产的花生过敏的成年患者开发了一种DBPCFC专利配方。该项目建立在这项技术的基础上，开发和验证用于幼儿的新型DBPCFC配方，这些配方将比目前的临床实践更安全、更准确、更广泛适用。这些配方将在该项目之后的人体试验中应用，以充分评估它们的临床效用。由此产生的诊断产品的规模化生产和销售有可能为患者和医疗保健系统直接节省超过12亿GB的资金。

Food allergy (FA) prevalence and hospitalisations are rising, especially in young children. Sufferers and their families face possible death from anaphylaxis, social exclusion, reduced Quality of Life, and high out-of-pocket costs. New treatments promise to revolutionise FA, stimulating strong demand for partner diagnostics. Today's gold-standard FA diagnostic is the double-blind, placebo-controlled food challenge (DBPCFC). Here, patients consume the suspect food, in incrementally increasing amounts, until a mild allergic reaction is observed versus an indistinguishable low/zero dose control challenge. However, current tests are unblinded, inaccurate, poorly scalable, and unsafe. This leaves the UK poorly equipped to face the large numbers of tests that will be required for vulnerable paediatric patients in the coming years.Reacta Biotech have developed a patented DBPCFC formulation for peanut-allergic adult patients produced under controlled conditions. The project builds on this technology by developing and validating novel DBPCFC formulations for young children that will be safer, more accurate, and more widely applicable than current clinical practice. The formulations will be applied in human trials following the project to fully evaluate their clinical utility. Scaled production and marketing of the resultant diagnostic products has the potential to directly save over £1.2Bn for patients and the healthcare system.