The present disclosure generally relates to methods and compositions for identifying and/or treating cancer patients harboring one or more molecular alterations in clinically important biomarkers, preferably in multiplexed assays, such that multiple biomarkers can be assayed simultaneously. In one embodiment, the disclosure relates to methods for rapid screening large populations of biological samples by using a high-throughput multiplexed assay to assess relative prevalence of multiple indications, optionally followed by a second analytical assay with higher sensitivity and specificity.

The present invention provides uses of cytokeratins as markers for diagnosing epithelium derived cancers. The present invention provides cancer-related epitopes of cytokeratins and monoclonal antibodies which specifically recognize the epitopes. The present invention also provides methods for the early screen, diagnosis or prognosis of epithelium derived cancers in subjects, methods for the evaluation of therapeutic effect of related medicaments or therapies, and kits for accomplishing the methods.

Disclosed herein are methods for identifying a subject as having NSCLC that is predicted or is likely to respond to treatment with an ALK inhibitor, for example crizotinib. The methods include identifying a sample including NSCLC tumor cells as ALK-positive or ALK-negative using immunohistochemistry (IHC) and scoring methods disclosed herein. A subject is identified as having NSCLC likely to respond to treatment with an ALK inhibitor if the sample is identified as ALK-positive and is identified as having NSCLC not likely to respond to treatment with an ALK inhibitor if the sample is identified as ALK-negative. According to certain embodiments of the methods, subjects predicted to respond to an ALK inhibitor may then be treated with an ALK inhibitor such as crizotinib.

The use of genomic tests shows variability between the primary tumor and the metastases in most circumstances referred to as tumor heterogeneity. Since it is unduly invasive and difficult to obtain samples from the primary and metastatic tumors within a patient, a need exists for a method of testing chemotherapeutic effectiveness in a patient that is applicable to both primary tumor and metastases. Provided are methods of using the MiCK assay to determine the most effective drug candidate(s) for an individual patient by testing a single tumor site. In a further embodiment, the kinetic unit (KU) value obtained by analysis of cancer cells from a tumor site in an individual patient in the presence of a drug candidate is within two standard deviations of the KU value obtained by analysis of a different tumor site in the patient in the presence of the same drug candidate.

This disclosure relates to methods of assaying and scoring PD-L1 expression in tumors. Tumor samples are labeled with an antibody or antibody fragment that specifically binds to human PD-L1 and binding is detected. Binding intensity is compared to background, and tumor cells having membrane staining above background are counted. The percentage of tumor cells containing membrane staining of PD-L1 is determined and the tumor is classified as “PD-L1 positive” if the percentage of tumor cells falls above a predefined level.

The present invention relates to a biomarker composition for diagnosing radiation-resistant cancer comprising PMVK as an active ingredient and a method of diagnosing radiation-resistant cancer using the same, and when the PMVK is knocked down, it is confirmed that the survival rate of cancer cells decreases during radiation treatment, and based on this, the possibility as a factor related to radiation therapy resistance to cancer was suggested, and the PMVK can be used as a new target to enhance the effect of radiation therapy on human cancer cells.

The invention provides PRKC gene fusions, PRKC fusion proteins, and fragments of those genes and polypeptides. The invention further provides methods of diagnosing and treating diseases or disorders associated with PRKC fusions, such as conditions mediated by aberrant PRKC expression or activity, or overexpression of PRKC.

Isolated or recombinant EphA5 or GRP78 targeting antibodies are provided. In some cases, antibodies of the embodiments can be used for the detection, diagnosis and/or therapeutic treatment of human diseases, such as cancer. A method of rapidly identifying antibodies or antibody fragments for the treatment of cancer using a combination of in vitro and in vivo methodologies is also provided.

Provided is a method for screening a compound that can specifically suppress the formation of caveolae of cancer cells and can inhibit the activity of various RTKs using a single compound all at once. A method for screening a compound specifically suppressing the formation of caveolae of cancer cells wherein the screening method includes a step for bringing a test compound into contact with a system capable of detecting suppression of the binding of Cavin-1 and CAV1 and a step for selecting a compound having activity to suppress the binding of Cavin-1 and CAV1.

A method for predicting whether a patient will be a long-term survivor on treatment of a disease by adoptive cell transfer (ACT), is disclosed comprising: (i) analysing a blood-derived sample obtained from the patient for one or more prognostic markers of long-term survival on treatment of a disease by ACT, and; (ii) based on the analysis of step (i), predicting whether the patient will be a long-term survivor on treatment of the disease by ACT. Also disclosed are methods for treating a patient by ACT, methods for selecting a patient for treatment by ACT, and methods for selecting a patient for treatment of a disease by ACT.