Abstract: Disclosed are markers, methods and assay systems for the identification of patients suspected of having cancer and/or cancer patients who are predicted to respond, or not respond to the therapeutic administration of specific chemotherapeutic regimens. Particularly, the invention provides a testing paradigm based on tumor cell samples to select cancer patients who will benefit from chemotherapy including one or more kinase inhibitor(s), as well as a paradigm to select cancer patients who will not benefit from such chemotherapy regimen.

Abstract: Disclosed are biomarkers, methods and assay kits for the identification of cancer patients who are predicted to benefit, or not to benefit, from the therapeutic administration of an epidermal growth factor receptor (EGFR) inhibitor. The biomarkers of the present invention include detection of EGFR and HER 2 gene amplification and polysomy, EGFR protein expression, EGFR mutations, phosphorylated Akt protein expression, and various combinations of such biomarkers, as well as the combination of these biomarkers with mutations in the tyrosine kinase domain of the EGFR gene. Increased EGFR gene copy number, increased HER2 gene copy number, increased EGFR protein expression, activated AKT protein expression (phosphorylated AKT) and EGFR mutations are all associated with better outcome for cancer patients treated with EGFR inhibitors.

Abstract: Disclosed are methods to obtain an expression score to evaluate gene expression in a tissue specimen obtained from a person having or suspected of having cancer.

Abstract: Disclosed are markers, methods and assay systems for the identification of patients suspected of having lung cancer and/or cancer patients who are predicted to respond, or not respond to the therapeutic administration of specific chemotherapeutic regimens. Particularly, the invention provides a testing paradigm based on tumor cell samples to select cancer patients who will benefit from chemotherapy including one or more kinase inhibitor(s), as well as a paradigm to select cancer patients who will not benefit from such chemotherapy regimen.

Abstract: Disclosed are biomarkers, methods and assay kits for the identification of cancer patients who are predicted to benefit, or not to benefit, from the therapeutic administration of an epidermal growth factor receptor (EGFR) inhibitor. The biomarkers of the present invention include detection of EGFR and HER 2 gene amplification and polysomy, EGFR protein expression, EGFR mutations, phosphorylated Akt protein expression, and various combinations of such biomarkers, as well as the combination of these biomarkers with mutations in the tyrosine kinase domain of the EGFR gene. Increased EGFR gene copy number, increased HER2 gene copy number, increased EGFR protein expression, activated AKT protein expression (phosphorylated AKT) and EGFR mutations are all associated with better outcome for cancer patients treated with EGFR inhibitors.

Abstract: Disclosed is the identification, provision and use of biomarkers predictive of sensitivity or resistance to EGFR inhibitors such as gefitinib and products and processes related thereto. Specifically, a method is described for selecting a cancer patient who is predicted to benefit from therapeutic administration of an EGFR inhibitor, an agonist thereof, or a drug having substantially similar biological activity as EGFR inhibitor. Also described is a method to identify molecules that interact with the EGFR pathway to allow or enhance responsiveness to EGFR inhibitors, as well as a plurality of polynucleotides or antibodies for the detection of the copy number or expression of genes that are indicative of sensitivity or resistance to EGFR inhibitors, an agonist thereof, or a drug having substantially similar biological activity as EGFR inhibitors. A method to identify a compound with the potential to enhance the efficacy of EGFR inhibitors is also described.

Abstract: Disclosed are biomarkers, methods and assay kits for the identification of cancer patients who are predicted to benefit, or not to benefit, from the therapeutic administration of an epidermal growth factor receptor (EGFR) inhibitor. The biomarkers of the present invention include detection of EGFR and HER 2 gene amplification and polysomy, EGFR protein expression, EGFR mutations, phosphorylated Akt protein expression, and various combinations of such biomarkers, as well as the combination of these biomarkers with mutations in the tyrosine kinase domain of the EGFR gene. Increased EGFR gene copy number, increased HER2 gene copy number, increased EGFR, protein expression, activated AKT protein expression (phosphorylated AKT) and EGFR mutations are all associated with better outcome for cancer patients treated with EGFR inhibitors.