Vivione Biosciences has received a Letter of No Objection (LNO) for its RAPID-B non-O157 Shigatoxigenic group of E.coli (STEC) test kit.
The US Department of Agriculture Food Safety and Inspection Service (USDA- FSIS) gave the LNO for the kit intended for rapid screening of beef trim and ground beef that may contain O-antigen positive Non-O157 STEC.
The test kit is used with Vivione's RAPID-B platform and is designed to provide companies with a faster result than existing options.
How it works
The RAPID-B system looks at each bacterium's physical properties (including size, shape, and transparency) and analyzes responses to probes and DNA dyes.
It allows testing of food products in seven hours or less, including sample preparation versus other commercial systems that take up to 48 hours to provide results.
Bacteria detection, data collection, and analysis results are provided after 60 seconds, not including sample preparation.
Testing is accomplished by adding RAPID-B proprietary reagents to an enriched sample and then running the sample on the instrument.
Kevin Kuykendall, chief executive officer, said the LNO was an important step for as it continues to expand in the food safety market.
"The designation is highly valued in the food industry because the testing is performed by an independent laboratory and the data is reviewed by the USDA,” he said.
“With this validation, our customers now have the assurance that they need to move forward with the RAPID-B system.
“As they do, they lower their inventory risk, get their product to market faster, help contribute to the safety and security of the global food supply chain, and increase consumers' confidence in the industry's commitment to food safety."
The firm also has a three-year Cooperative Research and Development Agreement (CRADA) with the FDA’s National Center for Toxicological Research (NCTR).
Deal inked with CMS Technology
Meanwhile, Vivione signed a definitive purchase agreement for the RAPID B system from CMS Technology Inc.
CMS Technology is a New York-based firm focused on developing and delivering products to mitigate pathogen risks in food, packaging and material applications.
Kuykendall described the deal as a ‘win-win’ for both companies.
"Vivione benefits by receiving both initial and recurring revenue under this agreement but also the opportunity for the RAPID-B system to be introduced into CMS's food producing customer base.
“CMS benefits by being able to scale its platform and immediately initiate real-time assessments of its antimicrobial treatments and coverings that the firm is developing."
Vivione said the agreement provides commercial validation of the RAPID-B system by demonstrating its benefits to the market and joint development and promotional opportunities.
John Meccia, CEO of CMS, said it surveyed the market and RAPID-B system met its microbial detection requirements.
“We can now clearly distinguish between live and dead microbes and we have clear enumeration which allows us to show real-time efficacy in our products and services,” he said.
“This cutting edge technology will enhance and accelerate our ability to develop solutions that make the food we eat and the products we use safer, longer lasting and more environmentally friendly."