The NESDEP IU system is a portable machine based on technology developed by Dr Hseuh-Chia Chang, at the University of Notre Dame and has several applications, one being food safety.
It can detect pathogens such as Listeria monocytogenes, E. coli O157, Salmonella and Campylobacter and more targets will be added in the future.
The firm said it detects pathogens in less than two hours, from introduction of a raw sample to completion of the assay.
F Cubed has a Cooperative Research and Development Agreement (CRADA) with the US Environmental Protection Agency (EPA) on E. coli and enterococcus and a research contract with Purdue University Food Safety Lab to conduct trials for pathogen testing on produce.
Bob Williams, VP of business development, said the technology is significantly faster than what is on the market now.
“We take a swab of a product, so for poultry you can do a swab of the thigh or breast of the chicken, or the rinse water of produce and you put the swab in the tube from the system,” he told FoodQualityNews.
“My background is in medical diagnostics and you deal with the FDA (US Food and Drug Administration) all the time. In food, FDA and USDA do not endorse products but the AOAC do trails, the problem here is two-fold.
“It takes six months to a year and up to $500,000 to $1m to go through the process. In medical diagnostics, you go to three hospitals and do 50 to 100 tests and turn to the FDA for approval, so it is easier and cheaper.
“We have no plans to go to the AOAC. Purdue Food Research Lab and three poultry firms are doing trials and parallel tests with a third party lab and we can use data we generate from these.”
How the test works
Each NESDEP IU test kit contains a biochip programmed to test for biological material.
It has a carbon nanotube biochip platform so when loaded it runs sample DNA through the carbon nanotube platform prompting a reaction and producing an electrical signal that indicates if the target is present or not.
“This is made possible through the use of an advanced sample preparation process that separates DNA from cellular material and the application of AC Dielectrophoresis to directly identify target DNA, with the ability to identify as few one cell in a sample with two base-pair discrimination,” according to the company.
The privately-funded company is also moving into a 7,000 square foot facility in South Bend, Indiana in April.
Williams said the current plan is to market the system in the US until it grows more and has more resources.
“The trials at Purdue and the companies should take no more than two to three months. We are looking at full production around the September (2016) time frame,” he said.
“Cost per test is comparable to sending it out to a lab, $25 to $50 depending on the volume.
“We started in medical testing only but I visited a produce company and they said food safety testing is going to explode. Eventually we will have multiplexing to run two or three tests on the biochip.”
Williams said there are no peripheral expenses and anyone can be taught to use it.
“You can take it into any business and run the system. The problem with food testing generally is where did the organism actually come from? We have seen this in the Chipotle example recently,” he said.
“In the US there are problems at farm level, those that run sloppy operations. FSMA has made people more aware of the problems and I know in my family, we’ve started to be more careful than in the past.
“The problem is the money and resources it will take to do everything they need to do but that helps highlight technology like ours.”
F Cubed also has a licensing agreement with Technion (The Israeli Institute of Technology) for the "Technion Discovery Platform" to develop molecular probes.
The firm said this agreement will allow it to develop and test new targets for the patented biochip kits in five days.