Food allergy diagnostics

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Composite blood-based biomarker analysis for accessible, safe and accurate food allergy diagnostics.

About the Technology

Food allergy is a serious, potentially life-threatening immunological response to food that is increasing in prevalence. Current methods for food allergy diagnosis and assessment rely heavily on directly challenging patients with an allergen, as is the case with the skin prick test (SPT) or the current gold standard, the oral food challenge. Routinely run tests, allergen-specific IgE blood test and the SPT, are widely known to be inaccurate. Yet food allergy diagnostics have not changed for over 50 years.

The basophil activation test (BAT) is a powerful ex vivo blood test for food allergy assessment, widely regarded as “a food challenge in a tube”. However, the assay is not broadly available clinically, in part due to the requirement for fresh blood and the complexity of the sample preparation steps before flow cytometry analysis. Conventional BATs rely on overnight shipping of fresh blood to a central lab equipped to perform the assay. However, BAT results become unreliable depending on shipping conditions (i.e., some positive results on day 0 become negative after shipping, and vice versa).

We have developed an automated sample preparation device to address this challenge by performing the most time sensitive steps of the BAT immediately after blood collection, followed by sample stabilization for up to 7 days before the sample needs to be analyzed in a flow cytometer. Our method maintains the BAT's accuracy and enhances its reliability. The HIT Fund will be used for engineering development of our prototypes, and the expertise provided by the HIT Fund advisors will set us on the right path towards commercialization.