Pain Point: This Small Business Innovation Research Phase II project proposes to develop an unprecedented, all-in-one handheld device that integrates food processing, assay chemistry and data interpretation, thereby allowing consumers to easily test their food for peanut and, in the future, other food allergens. Food allergies are a growing food safety and public health concern in the United States (Gupta, R. JAMA Pediatrics, 2013; Liu, AH. J Allergy Clin Immunol, 2010), affecting 6–8% of the children under 4 and 3.7% of adults (Report of the NIH Expert Panel on Food Allergy Research, 2006). Peanut allergy is the most common cause of food allergy- related fatalities in the US (Bock, S.A. J Allergy Clin Immunol, 2007). Among children, peanut is the most prevalent dietary allergy, accounting for 25% of all food allergies. A strict and lifelong peanut-free diet is the only current treatment for these patients, but it can be difficult to adhere to because of (a) cross-contamination during food manufacturing and preparation processes and (b) inadequate labeling and testing mechanisms (Remington, B.C. Food Chem Toxicol, 2013). Traditional peanut tests are (1) complicated – most kits require 7+ steps and certain steps involve equipment that is not readily available to the user, such as a scale or grinding device; (2) expensive – costing more than $14 per test; and (3) time consuming – taking longer than 18 min per test. Fundamentally, there does not exist a consumer-oriented product that peanut-sensitive individuals can use to proactively ensure the safety of their food. Technological Innovation: Nima is building the first and only rapid and user-friendly solution that enables consumers to test their food for dietary allergens. The all-in-one, handheld device, NimaTM, internally grinds the food, extracts allergen proteins (specifically peanut protein under this proposal) with Nima’s proprietary extraction solution, performs the immunoassay and interprets the result, all within 3 minutes. Performing all of these operations internally significantly simplifies the test, minimizes opportunities for user error and variation and builds confidence in the test result. Further, users will have the option to automatically upload test results via Bluetooth to a mobile app that Nima is building. Results will be collected by both consumers and the Nima team and automatically entered into a database. Nima aims to build the largest living allergen (and gluten) test result database in the US, which will serve as a resource to the community living with food allergies, so that consumers can make smarter decisions about where and what to eat. Broader Impacts of the Technology are to provide food sensitive individuals, their parents or other caregivers, health care providers and food manufacturers with an easy means of testing foods, ensuring food safety and improving health. While Nima’s first product (now on the market) focused on gluten detection and the second will focus on peanut detection, this technology platform is expected to expand to the detection of other common food allergens or irritants, including tree nuts, dairy products, eggs and soy, among others.

Relevance to Public Health: The objective of this project is to develop and commercialize an economical, accurate, fast and portable device for peanut allergen detection in foods, which can be readily used by consumers on a regular basis. It will provide peanut allergy sufferers, parents of children with food allergies, health care providers, food manufacturers and restaurants with a means of testing foods to better ensure safety, thereby improving consumer health and quality of life, as well as reducing long-term medical costs. This product is similar to our recently released first product, a gluten detector, but requires much more sensitive technology and we will ultimately extend this platform to detection of all major food allergens.