SAFETRACES, INC — Department of Health and Human Services SBIR Phase I: FDA

Description

DESCRIPTION provided by applicant In the CDC estimated that in the U S alone deaths are caused each year due to foodborne illness The cost to treat food poisoning comes to $ billion a year according to a July study published in the Journal of Food Protection including the medical expenses of the who are hospitalized annually The total cost to the U S economy is estimated to exceed $ billion annually One key to reducing foodborne illnesses is proper sanitation and subsequent verification in food processing operations Without effective methods in place microbiological contamination can result in food spoilage reduction in shelf life and food quality and foodborne illnesses Existing sanitation verification methods have significant challenges that impede their effectiveness and create an opportunity for a novel approach Advances in bioengineering have produced a material that enables the development of a highly efficient effective and low cost sanitation verification method This material is DNATrax a biological tracer developed at Lawrence Livermore National Laboratory and exclusively licensed for all fields of use to SafeTraces DNATrax offers an opportunity to verify sanitation in food processing plants by using the product as a pathogen surrogate during the sanitation process These surrogates are short DNA sequences encapsulated in food safe materials of different properties that under sanitation conditions behave in ways that correlate well to the behaviors of their corresponding target pathogens They will be applied before the sanitation process and if found after sanitation serve as indicator that sanitation was not performed properly Detected within minutes DNATrax based surrogates will allow for accurate sanitation verification more quickly than previously possible enabling timely sanitation intervention DNATrax is a safe and versatile material already recognized by the Food and Drug Administration as a Generally Recognized As Safe GRAS food additive This project aims to establish the feasibility of developing a DNATrax based method to rapidly and effectively verify whether sanitation in food processing operations has been executed according to governmental standards Specifically this will entail a the development of DNATrax as a single surrogate for a target pathogen b the laboratory evaluation of the surrogate and benchmarking against the target pathogen and c the development of a LAMP assay for fast low cost detection of pathogen surrogates in collaboration with Diagenetix In addition the project aims to establish that from a cost perspective DNATrax will be a viable technology for different sectors of the food industry including small businesses PUBLIC HEALTH RELEVANCE Food Safe Pathogen Surrogates for Rapid Verification of Sanitation in Food Processing Food related emergencies cause approximately deaths in the USA each year and their impact can be significantly mitigated with the improved ability to verify sanitation in food processing operations Existing sanitation verification methods are not always accurate and may require days to produce results We propose the development food safe pathogen surrogates and a detection method which will allow effective low cost sanitation verification for food processing facilities in a few minutes with very high level of confidence