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For In Vitro Diagnostic Use. The Prostate-63 Cancer Diagnostic Test features a mouse monoclonal antibody, clone 4A4, that recognizes the human p63 protein in the nucleus of prostatic basal cells and urothelial tissues. This test is intended for laboratory use to qualitatively identify by immunohistochemistry the p63 antigen in histological sections from formalin-fixed paraffin-embedded tissue of normal and/or pathological prostate tissue obtained by needle biopsy or surgical procedures. The presence or absence of p63 staining aids the pathologist in the differential diagnosis of prostate cancer in conjunction with morphological findings seen with hematoxylin and eosin staining complemented by proper controls. The clinical interpretation of any staining or its absence should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

The Prostate-63 Cancer Diagnostic Test features a mouse monoclonal antibody, clone 4A4, that recognizes the human p63 protein in the nucleus of prostatic basal cells and urothelial tissues. The 4A4 anti-p63 monoclonal antibody is provided at a working dilution in a buffer containing 50 mM Tris-HCl, pH 7.2, and 15 mM sodium azide. The immunogen is p63 recombinant protein comprising amino acids 1-205 of the N-terminal portion of human △Np63 protein.