BD Diagnostics, a segment of global medical technology company BD (Becton, Dickinson and Company), and Diagenode SA, an international biotech company based in Belgium, announced today the availability of the CE-marked Diagenode Enteric Viral Panel primers and probes kit that is used with the BD MAX™ RNA extraction kit RNA3 and BD MAX™ PCR Cartridges. In addition, BD announced the availability of the CE-marked BD MAX™ Enteric Bacterial Panel for use on the BD MAX™ System.
The Diagenode Enteric Viral Panel primers and probes kit is an automated in vitro diagnostic (IVD) test for the qualitative detection of norovirus (genogroups I and II) and rotavirus species in stool specimens. The BD MAX Enteric Bacterial Panel is a qualitative IVD test detecting DNA from Campylobacter spp. (jejuni and coli), Salmonella spp., Shigellosis disease (Shigella spp./Enteroinvasive E. coli [EIEC]) as well as Shiga-toxin Types 1a and 2a in stool specimens.
“The expanding BD MAX System product menu and open system capabilities, full automation and standardized workflow will enable laboratories to consolidate and standardize a broad range of molecular tests to build programs that meet both their current and future clinical needs,” said Tom Polen, President, BD Diagnostics Diagnostic Systems. “BD’s suite of enteric assays on the BD MAX System will allow for targeted testing needs based on patient and clinical presentation, optimizing both clinical and economic outcomes.”
Infectious gastroenteritis accounts for 1 billion cases of diarrhea globally and more than 2 million deaths annually. These infections may be caused by viruses, bacteria or parasites and often take two to three days to identify in the clinical laboratory using conventional methods. Enteric viruses are the most common cause, accounting for millions of gastroenteritis cases annually across the European Union. During 2012 several countries across the European Union saw an increase of as much as 83 percent in the number of cases reported as compared to last year. Early and rapid diagnosis is critical in stopping the transmission of this highly contagious disease.
These new products available on the BD MAX System provide laboratory technicians with a fully automated system that standardizes the extraction process and offers ease-of-use and improved laboratory workflow. “The Diagenode Enteric Viral Panel kit offers the capability to test for both norovirus and rotavirus as part of a fully validated, CE-marked product on the BD MAX System. This further leverages the unique open system capability of the instrument as well as our IVD development expertise to provide a diagnostic offering for the enteric disease syndrome,” stated Didier Allaer, CEO of Diagenode.
In addition to panels detecting enteric viral and bacterial pathogens, a BD MAX™ Enteric Ovum and Parasite Panel is currently in development for the qualitative detection of parasitic enteric pathogens Giardia lamblia, Cryptosporidium spp. (C. hominus andC. parvum), and Entamoeba histolytica directly from stool specimens in patients with signs and symptoms of gastroenteritis and/or colitis.
BD plans to continue expanding the BD MAX molecular testing menu through internal development and the Diagenode collaboration by launching additional assays throughout 2013.
BD (bd.com) is a leading global medical technology company that develops, manufactures and sells medical devices, instrument systems and reagents. The Company is dedicated to improving people's health throughout the world. BD is focused on improving drug delivery, enhancing the quality and speed of diagnosing infectious diseases and cancers, and advancing research, discovery and production of new drugs and vaccines. BD's capabilities are instrumental in combating many of the world's most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs nearly 30,000 associates in more than 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, the pharmaceutical industry and the general public.
Diagenode (diagenodediagnostics.com) is a leading developer and marketer of innovative life-science tools and systems for epigenetics and molecular diagnostics. Diagenode is developing novel products for the infectious disease diagnostic market, but is also providing a complete solution for epigenetics research. Diagenode’s customers include leading epigenetics researchers, academic institutions, molecular diagnostics, pharmaceutical and biotechnology companies. Diagenode’s products provide customers with the best quality and performance and allow scientists to produce consistent, cost-effective and robust results.
Eurosurveillance, Volume 18, Issue 1, 03 January 2013