NIMA LABS, INC. — Department of Health and Human Services SBIR Phase I: 300

Description

DESCRIPTION provided by applicant An Integrated Accurate Rapid and Inexpensive Handheld Consumer Gluten Detector Pain Point of the US population suffers from celiac disease Han PNAS pp and an additional suffers from some form of intolerance to dietary gluten Sapone BMC Medicine pp In addition of adults and of children under have food allergies Food allergy accounts for of emergency room visits for anaphylaxis NIAID report Specifically for gluten despite the increasing availability of gluten free options consumers continue to become ill from unintentional gluten ingestion largely due to cross contamination of foodstuffs during food manufacturing and preparation processes and inadequate food labeling and testing mechanisms Thompson J Am Diet Assoc pp Traditional gluten tests are complicated with multiple processing steps and results that are difficult to interpret expensive costing $ to $ per test and time consuming taking andgt min per test Currently there is no consumer oriented product that gluten sensitive individuals can use to ensure their food safety Technological Innovation Our solution is an all in one handheld device called the NimaTM which integrates food processing gluten detection result interpretation and data transmission thereby allowing consumers to easily test their food for allergens This test will not only enable consumers to verify the safety of foods while cooking at home or dining out but also allow parents to confidently and safely provide food for their children at home Consumers only need to put a small sample grams into the disposable cassette which is then inserted into the reader The device internally grinds the food extracts the gluten with our propriety extraction solution and performs the immunoassay The built in reader then analyzes the test strip giving the user a binary result which is based upon the FDA defined threshold of ppm gluten Our device is expected to analyze gluten content in both simple and complex food matrices with a Limit of Detection andlt ppm and Overall Detection Time andlt minutes We also aim to build the largest living gluten test result database in the US which will interface with our mobile app as a resource to the gluten free community Test results will be generated by consumers as well as professionals from SensorLabs The database will help consumers identify reliable gluten free foods stores manufacturers and restaurants which will in turn incentivize food manufactures and other food providers to better adhere to gluten free practices 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 our first product will be focused on gluten detection we expect to expand this technology platform to the detection of other common food allergens or irritants including peanuts tree nuts dairy products eggs soy among others in the near future PUBLIC HEALTH RELEVANCE An Integrated Accurate Rapid and Inexpensive Handheld Consumer Gluten Detector Relevance to Public Health The objective of this project is to develop and commercialize an economical accurate fast and portable device for gluten detection in foods which can be readily used by consumers on a regular basis It will provide gluten sensitive consumers 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 Ultimately we plan to extend this platform to the detection of all major food allergens