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Bio-Rad Laboratories Announces FDA Approval For ToRC IgG And HSV-1 & HSV-2 IgG Kits

Bio-Rad Laboratories, Inc. announced the FDA clearance of two new multiplex infectious disease serology panels for use on the BioPlex 2200 system: the BioPlex ToRC IgG panel and the BioPlex HSV-1 & HSV-2 IgG panel. The BioPlex 2200 system is a fully automated, random access platform that employs multiplexing technology to analyze multiple disease markers from a single patient sample.

The ToRC IgG kit simultaneously detects IgG class antibodies to Toxoplasma gondii (T. gondii), Rubella, and Cytomegalovirus (CMV). T. gondii, Rubella, and CMV can cause a variety of serious conditions in an unborn fetus including blindness, retardation, and death. The HSV-1 & HSV-2 IgG kit utilizes type-specific proteins to simultaneously detect and differentiate IgG class antibodies to the two most common herpes subtypes, HSV-1 and HSV-2. The ToRC IgG kit is available for sale and the HSV kit is pending launch.

The launch of the ToRC IgG kit and upcoming launch of the HSV-1 & HSV-2 IgG kit are two significant steps in expanding the BioPlex 2200 serology testing menu, said John Goetz, Bio-Rad Vice President and Group Manager Clinical Diagnostics. Using these two products, laboratories will be able to take advantage of the power and efficiency of multiplexing. Later this year we look forward to launching additional panels, further expanding our infectious disease serology and autoimmune menu for the platform.

The BioPlex 2200 system is the first and only fully-automated, random access multiplex testing system and provides clinical laboratories with the capability to rapidly process or multiplex multiple individual tests that are traditionally processed separately using a single small volume patient sample.