Industry News

Our news page will keep you informed of press releases and news articles on rapid and alternative microbiological method technologies and updates from technology suppliers.

Please click here to submit your news.

FDA and Vivione Biosciences Enter into a 3-Year Cooperative Diagnostic R&D Agreement

Vivione Biosciences Corporation announced a new three-year Cooperative Research and Development Agreement (CRADA) with the Food and Drug Administration's (FDA) National Center for Toxicological Research (NCTR). The focus of the CRADA is to expand the capability of Vivione's RAPID-B(TM) diagnostic system.

The Vivione RAPID-B(TM) system is a revolutionary high-performance diagnostic system for detecting bacterial pathogens. Unlike other systems that look at a gross response of an entire sample to provide information, the RAPID-B(TM) system looks individually at each bacterium's physical properties (including size, shape, and transparency) and analyzes unique responses to probes and DNA dyes. RAPID-B(TM) allows the 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. Moreover, single shift results are achieved without the need for labor intensive sample preparation steps including centrifugation and immuno-magnetic separation.

The implication for the general public is that RAPID-B(TM) can yield better and faster micro results than current methods, making food and consumer products safer. "New research contemplated under the CRADA will augment the present RAPID-B(TM) assays for food safety," said Ted Moskal, Vivione's President and Chief Science Officer. "We are developing new methods that can rapidly identify the pathogens responsible for disease outbreaks beyond food-borne illnesses." Moskal further explained that the new research will expand to include the tiniest disease-causing agents known to man, particularly viruses and prions, for which there are no current detection methods available.

CEO of Arkansas Research Alliance, Jerry Adams said, "I'm very pleased NCTR-FDA has entered into a CRADA with Vivione. The relationship between government research and commercial entities is important for the development of new technologies and employment. The development of better, faster and less expensive diagnostics is both key to maintaining a safer food supply and also to yield better outcomes for identification of infectious disease in clinical settings. The Research Alliance is hopeful that this collaboration will lead to the development of new diagnostics, the growth of biosciences in the state and more knowledge-based jobs."

In both clinical as well as food safety settings, very low pathogen levels can cause human morbidity and mortality, particularly in such susceptible populations as the elderly, children and immune-suppressed individuals. RAPID-B(TM) has the ability to detect extremely low levels of infectious agents in complex biological matrices, thus potentially increasing early diagnoses, specifically in time-critical situations.

Overall the research under the CRADA will strive to expand the utility of RAPID-B(TM) to a greater variety of locations and contexts, including field settings and clinical venues. According to Moskal, the goal is to design and test new RAPID-B(TM) assays capable of real-time detection of diverse pathogens directly from the native sample thus reducing the steps associated with typical sample preparations and yielding faster, simpler and cost-effective diagnostic tests.

Arkansas Governor Beebe said, "The State of Arkansas applauds the new Cooperative Research and Development Agreement between the FDA National Center for Toxicological Research and Vivione Biosciences. Public-Private partnerships for research are critical to the development of new products that benefit the public and keep America competitive. The biotech sector is increasingly more important to the generation of knowledge-based jobs. We're so proud that both organizations are located in the state of Arkansas."

Post a Comment

Previous Post Next Post

Contact Form