SBIR Phase I: Consumer Food Allergen Detection Instrument

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) project is to develop the first consumer hand-held instrument for the accurate and immediate detection of allergens in food. This technology will enable people to test their food immediately prior to consumption for the presence of food allergens that they need to avoid. The target market is the 15 million people in the US and 150 million people worldwide who have food allergies. It is anticipated that this technology will have a significant impact on health and quality of life of these individuals. The novel detection platform under development enables instant detection and has many intrinsic advantages including the ability to be modified using a fast, reproducible, and scalable process. It is small and inexpensive to manufacture, is easily mass produced and is stable over a range of chemical and environmental conditions. All of these make this detection platform optimal for immediate detection in a consumer device. By incorporating this detection platform into an instrument and disposables that will sample food in a controlled way, extract proteins, detect target protein levels and clearly display the result, it is believed that this is a disruptive technology that will fundamentally change how people manage their food allergies. This SBIR Phase I project proposes to develop a food allergen detection platform that is a hand-held consumer instrument that samples food, extracts protein, and detects the presence of an allergen at a clinically defined threshold in under a minute. It is based on designed signaling allergen-specific small molecules that bind with high specificity and selectivity, and are utilized for testing minute concentrations of food allergens. In addition, all subsystems of the detection instrument that can sample food, extract protein by chemical and physical homogenization and test for the presence of food allergens are included in the design. In this Phase I study, the sampling, homogenization, and detection mechanism will be integrated into a hand-held consumer instrument. The three major challenges to be addressed will be 1) Optimize the design, and test the fully functional instrument; 2) Integrate the detection platform with the instrument; and 3) optimize the food sampling mechanism. Successfully addressing these three goals and creating a fully functional prototype will not only enable the commercialization of a consumer product that can instantly detect food allergens but also may serve as proof-of-concept for future point-of-care diagnostic capabilities.