Bio-Rad gets FDA approval of software that supports FDA-approved BioPlex System

By E. Janene Geiss

Philadelphia, Nov. 16 - Bio-Rad Laboratories, Inc. announced Wednesday that it received FDA approval for its Medical Decision Support Software designed for use with the company's FDA-cleared BioPlex 2200 ANA Screen and BioPlex 2200 System, interpretive software used to correlate patient antibody results with specific autoimmune diseases.

Using the Medical Decision Support Software (MDSS) with the Bioplex screen, autoimmune laboratories now will be able to provide physicians with valuable information on possible disease associations for patient antibody profiles, information that has never before been available through a clinical diagnostic system, according to a company news release.

"This unique collection of products will help clinical laboratories improve their autoimmune testing processes and further enhance the quality of service they provide to doctors and patients," John Goetz, vice president of Bio-Rad's Clinical Diagnostics Group, said in the statement.

Bio-Rad said the BioPlex 2200 System is the first and only fully automated random access multiplex testing system available, providing clinical laboratories with the technology to rapidly process, or "multiplex" multiple individual tests, traditionally processed separately, using a single small volume patient sample.

The system is capable of generating up to 1,200 autoimmune test results per hour. Also in development are additional panels for autoimmune and infectious diseases, cardiac diseases and diabetes.

Bio-Rad is a Hercules, Calif., manufacturer and distributor of life science research products and clinical diagnostics.

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