Phase II Amount
$1,072,272
An Integrated, Accurate, Rapid and Inexpensive Handheld Consumer Gluten Detector Pain Point: 1% of the US population suffers from celiac disease (Han, 2013 PNAS 110: pp.13073), and an additional 6% suffers from some form of intolerance to dietary gluten (Sapone, 2012 BMC Medicine 10: pp.13). In addition, 3.7% of adults and 6-8% of children under 4 have food allergies. Food allergy accounts for 35-50% of emergency room visits for anaphylaxis (NIAID 2006 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, 2010 J Am Diet Assoc 110:pp.937). Traditional gluten tests are (1) complicated - with multiple processing steps and results that are difficult to interpret; (2) expensive - costing $12.5 to $16 per test; and (3) time consuming - taking >15 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 (~0.5 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 20 ppm gluten. Our device is expected to analyze gluten content in both simple and complex food matrices, with a Limit of Detection < 5 ppm and Overall Detection Time < 2 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 6SensorLabs. 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 Statement: 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.
NIH Spending Category: Clinical Research; Food Allergies; Foodborne Illness; Nutrition; Prevention
Project Terms: Accounting; Adult; Affinity; Anaphylaxis; Antibodies; Avena sativa; Barley; base; Biological Assay; Caregivers; Celiac Disease; Cereals; Chemistry; Child; cloud based; Communities; Complex; Consumption; cooking; cost; cross reactivity; Dairy Products; Data Analyses; data exchange; Databases; Detection; detector; Devices; Diet; Economic Development; egg; Emergency department visit; Ensure; Evaluation; Feasibility Studies; Food; food allergen; Food Hypersensitivity; Food Labeling; Food Processing; Food Safety; Funding; Future; Generations; Gliadin; Gluten; Government; handheld equipment; Health; Health Personnel; Home environment; Immunoassay; improved; Individual; Ingestion; Irritants; Label; Lateral; Lead; Life; Manufacturer Name; Medical; Medicine; mobile application; National Institute of Allergy and Infectious Disease; National Institute of Diabetes and Digestive and Kidney Diseases; Nuts; Pain; Parents; Performance; Persons; Phase; Population; Preparation; Price; Process; Program Development; Property; Proteins; prototype; Provider; Public Health; Quality of life; Reader; Reporting; Research; Resources; response; Restaurants; Rice; Rye cereal; Safety; Sampling; sensor; sharing data; Small Business Innovation Research Grant; Small Business Technology Transfer Research; soy; System; technological innovation; Technology; Test Result; Testing; Time; Trees; United States National Institutes of Health; Wheat; Work
