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Vivione Receives Go Ahead from US Department of Agriculture for Its Rapid E. coli STEC Kit

Vivione Biosciences Inc. ("Vivione") is pleased to announced that, following a lengthy and vigorous process, the USDA FSIS (US Department of Agriculture Food Safety & Inspection Services) has issued Vivione a Letter of No Objection ("LNO") for its RAPID-B non-O157 Shigatoxigenic group of Escherichia coli ("STEC") Test Kit, intended for the 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. Testing is accomplished by adding RAPID-B proprietary reagents to an enriched sample and then running the sample on the RAPID-B instrument. Analysis of the sample by the instrument is accomplished in minutes. The decision to adopt a new diagnostic testing platform is a serious decision for any company and the process needs to be absolutely trustworthy. Today's USDA FSIS designation enables companies to acquire and deploy the RAPID-B process with complete confidence that RAPID-B meets some of the world's toughest, most demanding testing standards. The LNO process involves the assessment of key platform parameters to ensure satisfactory performance and the ability to consistently produce accurate results.

According to the CDC (Center for Disease Control), an estimated 265,000 STEC infections occur each year in the United States. The importance of speed and sensitivity in detecting the presence of certain E. coli bacteria cannot be overestimated. E. coli contamination can have very serious economic and safety consequences to the meat industry, as well as immense public health implications. Any product containing these bacteria that inadvertently reaches the market would be subject to recall, with the likelihood of producers suffering both significant financial and reputational harm. As a result, meat producers currently hold inventory sufficiently to ensure that the product is not contaminated. The sooner a negative result is received, the faster the product can be released for shipment. The bottom line for producers is that the faster a result is received, the faster a producer can respond or ship their product to market.

"This LNO designation is an important step for us as we continue to expand in the food safety market," said Vivione's Chief Executive Officer Kevin Kuykendall. "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. 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."

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