SBIR-STTR Award

Adaptation of an Enrichment-Free Listeria Diagnostic to Food Matrices
Award last edited on: 11/25/2019

Sponsored Program
SBIR
Awarding Agency
NIH : NIAID
Total Award Amount
$1,145,149
Award Phase
2
Solicitation Topic Code
855
Principal Investigator
Cesar Nadala

Company Information

Phage Diagnostics Inc (AKA: Sample6)

15300 Bothell Way Ne
Seattle, WA 98155
   (800) 491-7745
   N/A
   N/A
Location: Single
Congr. District: 07
County: King

Phase I

Contract Number: 1R43FD005340-01A1
Start Date: 9/15/2015    Completed: 2/29/2016
Phase I year
2015
Phase I Amount
$150,000
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: 48 million illnesses, 28,000 hospitalizations, and at least 3,000 deaths per year. The impact on healthcare, business and industry is no less pronounced, resulting in annual costs of $14-$16 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. Sample6 is developing the world'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 (<7h). 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/L'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 Statement:


Public Health Relevance:
Foodborne pathogens cause 48 million illnesses, 28,000 hospitalizations, and at least 3,000 deaths each year in the U.S., resulting in annual costs of $14-$16 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.

Project Terms:
No Project Terms available.

Phase II

Contract Number: 2R44AI131952-02
Start Date: 4/1/2017    Completed: 12/31/2017
Phase II year
2017
(last award dollars: 2018)
Phase II Amount
$995,149

Foodborne illnesses devastate 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. Each year, 1 in 6 people in the U.S. are sickened by foodborne pathogens. In 2014, there were 19,542 laboratory confirmed infections, 4,445 hospitalizations and 71 deaths attributed to the 9 major pathogens transmitted commonly through food. Listeria is the one of the most serious offenders, with a 96% hospitalization rate and a 12.9% mortality rate. The impact on healthcare, business and industry is no less pronounced, resulting in annual costs of $14.1 to $16.3 billion, including direct medical costs and value of time lost to illness. Moreover, the cost of keeping food safe from Listeria contamination was estimated to range between $2.4-$2.6 billion. 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. Sample6 is developing the world’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 (<7h). Sample6’s proprietary Bioillumination Platform enables this expeditious turnaround, enabling 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 II study will continue the work begun in Phase I to adapt the DETECT/L assay for finished product testing. First, the researchers will expand the number of Listeria strains to 10. Next, assay development will be completed for the six foods begun in Phase I, plus 30 more foods. Finally, Sample6 will develop high-throughput methods so that food manufacturers and packagers can test multiple food samples at a time for efficiency.

Public Health Relevance Statement:
Narrative Listeria is the one of the most serious foodborne pathogens, with a 96% hospitalization rate and a 12.9% mortality rate. The impact on healthcare, business and industry is no less pronounced, resulting in annual costs of $14.1 to $16.3 billion, including direct medical costs and value of time lost to illness. This project will adapt Sample6’s 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.

Project Terms:
American; Area; assay development; Back; Bacterial Infections; Bacteriophages; Biological Assay; Businesses; Campylobacter; Cantaloupes; Case Study; Categories; Cause of Death; Cells; Centers for Disease Control and Prevention (U.S.); Cessation of life; Clinical; clinically relevant; Collection; Consumption; cost; Data; Detection; Development; Diabetes Mellitus; diabetic; Diagnostic; Disease; Disease Outbreaks; Eating; Engineering; Enteral; Environment; Enzymes; Etiology; Food; Food Contamination; food quality; Food Safety; foodborne; foodborne illness; foodborne pathogen; gastrointestinal; Guidelines; Health; Health Care Costs; Healthcare; Hospitalization; Hospitals; Human; Ice Cream; Incidence; Individual; Industrialization; Industry; Infection; Irritable Bowel Syndrome; Kidney Failure; Laboratories; Left; Life; Listeria; Listeria monocytogenes; Location; Manufacturer Name; Measures; Meat; Medical; Methods; microbial; Modality; mortality; new technology; novel; offender; Packagings; Pancreatitis; pathogen; Pathogen detection; Personal Satisfaction; Persons; Phase; phase 2 study; Plants; Population; Process; Production; Public Health; Reagent; Reporting; Research Personnel; Risk; S-Adenosylmethionine; Safety; safety testing; Salmonella; Sampling; screening; shift work; Shipping; Signal Transduction; Source; Specificity; Surface; surveillance network; System; Technology; Test Result; Testing; Time; United States Food and Drug Administration; Validation; Water; Work