Women's Health Weekly
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Breast Cancer
FDA approves InSite Her-2/neu Kit
March 3rd, 2005
BioGenex Laboratories, Inc., has received the premarket approval from U.S. Food and Drug Administration (FDA) for its InSite Her-2/neu Kit. This in vitro diagnostic kit is used to identify breast cancer patients eligible for treatment with the cancer drug Herceptin (Trastuzumab). InSite Her-2/neu is a complete kit, in manual and automated format, containing all components required for the performance of immunohistochemistry (IHC) staining of breast cancer tissue. 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 the InSite...
Source: Women's Health Weekly (2005-03-03)
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