The Collaborative Research and Development Agreement (CRADA) involves the FDA’s Center for Food Safety and Nutrition (CFSAN), Center for Veterinary Medicine (CVM) and Winchester Engineering Analytical Center (WEAC).
The goal is to test the bacteriophage-powered, Listeria pathogen testing system to validate an assay for detection in the environment and in foods.
Work started earlier this year and will continue until late 2018.
It also covers upcoming products such as Salmonella assays for environmental and food product testing and expanding Listeria to cover product testing.
Inclusion in BAM
Michael Koeris, founder and vice president of operations for Sample6, said a CRADA is generated when the FDA wants to work with someone and use the test.
“Another reason is we only have Listeria, but are on the verge of other tests, it gives us the ability to further develop assays. It came about when the FDA reached out to us, we have never done one before," he said.
“It is a multi-centre validation study. One requirement for the FDA is it needs to be an official method in the Bacteriological Analytical Manual (BAM) and for that you need a multi-centre validation study. We might have AOAC but they want to do their own validation.
“One output would be inclusion in the BAM so an official method, the first on-site, in-shift test. Independently, FDA could be a large user, adopter and buyer of this system.
“[The CRADA] will help us in Mexico and Latin America, Canada with Health Canada is its own beast but we are actively pursuing that, but mainly it will help in the US market.”
Koeris said they would publish papers in scientific journals about the performance of the assays.
Sample6 DETECT/L is an in-plant, in-shift pathogen detection for Listeria spp. It is an enrichment-free, on-site, in-shift pathogen diagnostic and works with analytics from Sample6 CONTROL.
The test is certified by the AOAC Performance Tested Method program, and adopted into the USDA FSIS Approved Assay List for Pathogen Tests and plants across the country.
As well as the CRADA work on Salmonella assays for environmental and food and expanding Listeria to cover food product testing, the firm is developing E. coli and Campylobacter assays.
The company is in more than 30 plants in the US and Canada, including ice cream, soy product, fresh produce and consumer packaged meats suppliers.
Sample6 was awarded a patent by the US Patent and Trademark Office (USPTO) strengthening the patent protection of its DETECT/L product.
The US patent discloses a cocktail of bacteriophages that can detect all species of the genus Listeria within one work shift.