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

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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.