Patent ID: 8580926

Claim:
An assay for determining if a patient diagnosed with colon cancer is a responder to treatment with irinotecan comprising (a) a means for determining expression levels in a tumor cell or tumor tissue, a sample which has been mounted in a tissue microarray (TMA), from the patient of each of ERBB2 consisting of the amino acid sequence of SEQ ID NO. 23, GRB7 consisting of the amino acid sequence of SEQ ID NO. 24, JNK1 kinase consisting of the amino acid sequence of SEQ ID NO. 26, BCL2 consisting of the amino acid sequence of SEQ ID NO. 27, MK167 consisting of the amino acid sequence of SEQ ID NO. 33, phospho-Akt consisting of the amino acid sequence of SEQ ID NO. 35, CD68 consisting of the amino acid sequence of SEQ ID NO. 36, and BAG 1 consisting of the amino acid sequence of SEQ ID NO. 37; wherein the means for determining the expression levels consist of one antibody for each protein; and (b) a system for predicting at least one of response to irinotecan therapy (RR), late recurrence (LRec) or disease-related death (DRD), comprising a database storing information of differential expression of the proteins of (a) in a tumor cell or tumor tissue from the patient as compared to normal colon tissue or cells, along with clinical information of the patient from whom the sample is obtained, an algorithm to correlate the differential expression of proteins to the patient information, and scoring criteria based on total percentage of staining by each antibody.