Methods and compositions for determining HER-2/neu expression
AssigneeAmgen Inc.
InventorRaymond A. Koski
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Abstract
Anti-p185HER-2/neu antibodies which are useful in the detection of HER-2/neu oncogene overexpression in biological samples are described. The antibodies are accurate and reliable in immunocytochemical or immunohistochemical assays of cell and tissue samples. Also described are methods for detecting HER-2/neu oncogene expression in a biological sample using the antibodies of the invention and a diagnostic kit comprising the antibodies. The reagents provide an accurate means of identifying certain cancer patients who have the greatest probability of relapse and/or the least likelihood of survival.
Claims19
A monoclonal antibody, or fragment thereof, which binds to a denatured epitope comprising a subset of amino acid residues 96-191 of the HER-2/neu protein as shown in FIG. 1B (SEQ ID NO:3), wherein the antibody detects HER-2/neu protein overexpression in cells or tissues with 80% or greater sensitivity.
A hybridoma cell line having ATCC accession no. HB11861.
A hybridoma cell line having ATCC accession no. HB11862.
Dependencies are inferred from the claim text.