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

食物过敏（FA）的患病率和住院率正在上升，特别是在幼儿中。患者及其家属可能因过敏反应、社会排斥、生活质量下降和高昂的自付费用而死亡。新的治疗方法有望彻底改变FA，刺激对合作伙伴诊断的强烈需求。目前FA诊断的黄金标准是双盲、安慰剂对照的食物挑战（DBPCFC）。在这里，患者食用可疑食物，逐渐增加量，直到观察到轻度过敏反应，而不是难以区分的低/零剂量控制挑战。然而，当前的测试是无盲的、不准确的、可扩展性差的和不安全的。这使得英国在面对未来几年将需要为脆弱的儿科患者进行的大量检测时装备不足。Reacta Biotech已经开发了一种专利的DBPCFC配方，用于花生过敏的成人患者在受控条件下生产。该项目以这项技术为基础，开发和验证适用于幼儿的新型DBPCFC配方，这些配方将比目前的临床实践更安全、更准确、更广泛地适用。该配方将在项目后用于人体试验，以充分评估其临床效用。由此产生的诊断产品的规模化生产和营销有可能直接为患者和医疗保健系统节省超过12亿英镑。

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.