Innovative Test for Diagnosis of Food Allergy

Innovative Test for Diagnosis of Food Allergy (GranulEye Test)

Allergios in collaboration with Wageningen University aims to optimize the GranulEye Test into a specific, reliable, safe and cost-effective in vitro allergy test, thereby enabling a proper diagnosis of patients suspected from food allergy.

Classical food allergy diagnosis has some major disadvantages. Skin prick- and IgE serum tests are good to measure sensitization but do not correlate optimally with the clinical status of the patient. The oral food challenge, the gold standard, is burdensome for the patient (time-consuming, side effects) and costly.  The GranulEye Test is a promising diagnostic tool which visualizes degranulation of basophil cells following allergen exposure.

This project involves the development of an AI method for the assessment of GranulEye images, upgrade of the GranulEye prototype to a semi-automatic device and a study of the analytical characteristics of GranulEye food allergy testing. Patients will benefit from the GranulEye Test because clarity about a potential food allergy will be obtained without the need of a burdensome challenge test.  Implementation of the novel test will enable better monitoring of the disease in patients who undergo treatment for their food allergy symptoms. Patients who currently take measures due to a suspected, non-justified food allergy can refrain from these measures in case of a negative GranulEye Test result. For these patients considerable savings in medication, e.g. Epipen, and preventive measures such as diets can be achieved.  Healthcare costs for diagnosis of food allergy will substantially decrease due to the relatively low price GranulEye allergy testing, approximately € 300 per test, compared to € 1,000 - € 1,500 per challenge test.

The ultimate aim of this project is to develop an AI-equipped, semi-automatic GranulEye device for food allergy testing and to demonstrate that its specificity is comparable to the gold standard.  

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Summary
There is currently an unmet need for novel, in vitro food allergy tests that are specific, reliable, safe to use and cost effective. Allergios in collaboration with Wageningen University aims to optimize the innovative GranulEye Test to improve the diagnosis of patients suspected from food allergy.
Technology Readiness Level (TRL)
5 - 7
Time period
24 months
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