FDA Approves BioGenex InSite Her-2/neu Kit

BioGenex Laboratories has received the premarket approval from 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 staining of breast cancer tissue.

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