Patent ID: 7908091

Claim:
An assay method for predicting the response of a subject diagnosed with a gastrointestinal stromal tumor (GIST) or renal cell carcinoma (RCC) to treatment with sunitinib (Sutent®), said method comprising: (a) analyzing a sample obtained from said subject to determine the presence or absence of an activating mutation in the c-KIT, PDGFRA, and VEGFR-1 genes and the level of c-KIT, PDGFRA, and VEGFR-1 protein expression in said sample, wherein said activating mutation in the c-KIT gene comprises a deletion, insertion, or single nucleotide substitution in exon 9, 11, 13, or 17 of the c-KIT gene, wherein said activating mutation in the PDGFRA gene comprises a deletion, insertion, or single nucleotide substitution in exon 12, 14, or 18 of the PDGFRA gene, and wherein said activating mutation in the VEGFR-1 gene comprises a deletion, insertion, or single nucleotide substitution in the juxtamembrane domain or the tyrosine kinase domain of the VEGFR-1 gene; and (b) predicting an increased likelihood that said subject will respond to treatment with sunitinib when said activating mutation in at least one of the c-KIT, PDGFRA, and VEGFR-1 genes is present, when at least one of the PDGFRA and VEGFR-1 proteins is overexpressed, and when the c-KIT protein is overexpressed.