The firm said it will provide the specification that will be used for DNA extraction and the modifications to FDA assays so they can be commercialized later this year.
The FDA will establish specifications that dictate the ways in which the final assay performs and will evaluate the performance of the commercial kits.
US Farm Bill legislation states only members of the Ictaluridae family can be legally marketed as catfish within the US.
Industry game changer
Steven Guterman, InstantLabs CEO, told FoodQualityNews the FDA has been developing the test to ensure catfish can be properly identified.
“We will be creating two commercial versions of the test, one that runs on InstantLabs’ Hunter system to take advantage of testing at the point of need and another that can operate on other PCR systems,” he said.
“The test can be used at multiple points in the supply chain. Government regulators, producers, processors and wholesalers have a need for this rapid testing to combat the increasing illegal substitution of cheaper imports that may not meet US production standards.
“The ability to confirm the species of a fish fillet in under two hours is a game changer for the industry.”
InstantLabs’ DNA-based technology will provide an alternative than requiring samples to be sent to centralized labs for sequencing, which often leads to a delay of one to two weeks.
US catfish have ranked among the top eight domestically consumed seafoods for the past several years, but consumption has fallen due to increasing sales of Pangasiidae fish mislabeled as catfish.
The Pangasiid fish family farmed in Southeast Asia is often misrepresented as the more expensive US catfish.
Guterman said health concerns have risen as increasing amounts of potentially contaminated imported catfish are consumed.
“Studies have discovered high concentrations of polybrominated diphenyl ethers (PBDEs) and hexabromocyclododecane (HBCD), a class of brominated flame retardants, in Pangasius catfish,” he said.
“Identification of fish species has become an important topic for consumers and regulators in the seafood industry because of the rising rate of international trade, global consumption, and changes in supply and demand of different species.
“These issues have led to economic fraud and substitution of low-value or potentially hazardous imported fish products being labeled as a more expensive or non-hazardous species.
“It is often difficult to authenticate fish species by traditional methods because processing removes identification features.”
CRADA and other work
InstantLabs entered into a Cooperative Research and Development Agreement (CRADA) with the FDA, which Guterman said was the first time it had done so.
“We meet with the FDA last year and they were interested in developing a commercially available ID test that could be utilized at the point of need,” he said.
“Our goal is provide as broad a range of relevant species ID test kits as possible. The ability to work with the FDA shortens the development cycle and allows us to use resources on additional species tests. It is also important for the US catfish industry to have a test available as soon as possible.”
Pangasiid frozen fillets shipped to the US rose to 215 million pounds in 2014, up from 7 million pounds in 2004, according to the National Oceanic and Atmospheric Administration (NOAA).
Imports are now valued at more than $300m a year and US farm-raised catfish production has fallen by nearly 50% from 630 million pounds in 2004 to 340 million pounds in 2012, according to the most recent data.
InstantLabs has launched DNA-based seafood identification tests under the InstantID brand that offer verification for Atlantic Blue Crab (Callinectes sapidus), Atlantic (Salmo salar) and Coho salmon (Oncorhynchus kisutch).
Additional salmon assays are planned for release in 2015.
The DNA-based seafood tests are developed through a partnership with the University of Guelph.
InstantLabs’ Hunter Real-Time PCR instrument is a portable system which can be used for species identification and food pathogen detection, delivering results quickly, allowing integration into firms’ processes and facilities.