Bio-Rad Receives FDA Clearance for New BioPlex(R) 2200 System
Bio-Rad Laboratories, Inc., a multinational manufacturer and distributor of life science research products and clinical diagnostics, announced today that it has received marketing clearance from the U.S. Food and Drug Administration (FDA) for its new BioPlex(R) 2200 system, a revolutionary new immunoassay platform that employs multiplexing technology to analyze for multiple disease states from single patient samples. It is the first clinical diagnostics platform to offer multiplexing technology on a fully-automated, fully-integrated random access platform. The system was unveiled last July at the American Association of Clinical Chemistry meeting and will soon be available in the U.S.
“We are excited about receiving FDA clearance for this important new technology and look forward to making it available to clinical laboratories. This unique system will improve the quality of patient testing, decrease turnaround time and eliminate the traditionally labor-intensive processes involved in specialty diagnostics. The development of the BioPlex 2200 system is another example of Bio-Rad’s commitment to providing valuable tools that enable laboratories to improve testing methods, maximize efficiencies and lower costs,” said John Goetz, Vice President of Bio-Rad’s Clinical Diagnostics Group.
The BioPlex 2200 system is a fully automated bead-based multiplexing immunoassay platform that can deliver up to 2200 results per hour. The system will initially include a panel of assays targeting autoimmune diagnostics. Future assays in development are in the areas of serology, infectious disease, cardiac and toxicology.
Bio-Rad Laboratories, Inc. ( http://www.bio-rad.com ) is a multinational manufacturer and distributor of life science research products and clinical diagnostics. It is based in Hercules, California, and serves more than 70,000 research and industry customers worldwide through a network of more than 30 wholly owned subsidiary offices.
