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BioGenex Laboratories, Inc.
U.S. Food and Drug Administration approves InSite HER-2/neu (CB11) monoclonal antibody
November 4th, 2005
BioGenex Laboratories, Inc., has received premarket approval from the U.S. Food & Drug Administration (FDA) for its InSite HER-2/neu (CB11) monoclonal antibody. This antibody is used in tests to identify breast cancer patients eligible for treatment with the cancer drug Herceptin (Trastuzumab). InSite HER-2/neu (CB11) is available as a ready-to-use reagent, in manual and automated formats, and is allowed for use with BioGenex Super Sensitive Detection Systems. The automated format is approved for use on the BioGenex i6000 Automated Staining System and the Optimax Plus Consolidated Staining System. Both manual and automated versions of InSite...
Source: Biotech Law Weekly (2005-11-04)
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