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    FDA Signs CRADA with Vivione Biosciences

    By Global Biodefense StaffNovember 20, 2013
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    Vivione Biosciences Corporation this week 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 diagnostic system.

    The Vivione system detects bacterial pathogens by looking individually at each bacterium’s physical properties (including size, shape, and transparency) and analyzes unique responses to probes and DNA dyes.  RAPID-B 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.

    The RAPID-B system 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.

    “New research contemplated under the CRADA will augment the present RAPID-B 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.

    “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,” said Jerry Adams, CEO of Arkansas Research Alliance.  “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.”

    The research under the CRADA will strive to expand the utility of RAPID-B to a greater variety of locations and contexts, including field settings and clinical venues.

    Agro-Defense Food Safety
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