SAMPLE6 TECHNOLOGIES, INC. — Department of Health and Human Services SBIR Phase I: FDA

Description

DESCRIPTION provided by applicant Foodborne illnesses devastate on the gastrointestinal microflora of millions of Americans each year often resulting in dysbiosis and increase risk of other diseases namely irritable bowel syndrome kidney failure pancreatitis and diabetes Furthermore diabetics are at increased risk of developing a foodborne illness and they often take longer to recover To realize the scale of the impact that foodborne pathogens have on the U S population contemplate these figures million illnesses hospitalizations and at least deaths per year The impact on healthcare business and industry is no less pronounced resulting in annual costs of $ $ billion including direct medical costs and value of time lost to illness Bacteria account for the majority of foodborne pathogens that cause morbidity and mortality More to this point bacteria are four of the top five pathogens that contribute to illness three of the top five that cause hospitalizations and three of the top five that cause mortality Contaminated food is the cause of these illnesses having entered the public supply due to a lack of detection at a manufacturing packaging plant distribution warehouse or retail location Current tests are inadequate because they require a prolonged enrichment step to reduce the likelihood of false negatives and false positives This enrichment causes tremendous delays in providing actionable results to the food processor who are left with one of two choices store the products until the test result comes back resulting in older lower quality food or shipping the food before receiving test results putting the consuming public at increased risk Sample is developing the worldandapos s first enrichment free foodborne pathogen detection system DETECT L is a rapid screening assay that detects a single Listeria spp cell on environmental surfaces in less than one work shift andlt h Our proprietary Bioillumination Platform enables this expeditious turnaround DETECT L enables food manufacturers and packagers to quickly and accurately detect and remediate contaminated environmental surfaces and solely retain product that is at risk of contamination However food can become contaminated internally during production shipping or in wholesale and retail environments downstream in the supply chain It is of vital importance to develop a second testing modality that assays the foodstuff as rapidly and sensitively as DETECT L does for environmental surfaces To this end the proposed Phase I study will adapt the DETECT L assay for finished product testing by directly detecting Listeria on five food products that are especially prone to Listeria contamination deli ham smoked salmon queso fresco spinach and ice cream First the researchers will determine the inhibitory effect that the food can have on DETECT Landapos s sensitivity Next the lower limit of detection LLOD of a gold standard assay USDA or FDA in detecting Listeria will be determined followed by a head to head comparison of DETECT L with the gold standard assays PUBLIC HEALTH RELEVANCE Foodborne pathogens cause million illnesses hospitalizations and at least deaths each year in the U S resulting in annual costs of $ $ billion including direct medical costs and value of time lost to illness These illnesses often result in dysbiosis and increase risk of other diseases namely irritable bowel syndrome kidney failure pancreatitis and diabetes Furthermore diabetics are at increased risk of developing a foodborne illness and they often take longer to recover This project will adapt the DETECT L test to detect Listeria directly on foodstuffs which ultimately will greatly reduce illness and death caused by foodborne pathogens while also increasing product shelf life and delivering fresher food to consumers