Standardized evaluation of therapeutic efficacy based on cellular biomarkers
AssigneeCell Work, Inc.
InventorsStephen A. Lesko, Paul O.P. Ts'o
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Abstract
The present invention provides materials and methods for predicting the response of a disease state to a therapeutic agent. A targeting moiety specific for a biological marker is labeled with a reporter moiety and used to analyze cells characteristic of the disease state. The output of the reporter moiety, which may be fluorescence intensity, is compared to the output of reference standard analyzed under similar or identical conditions. The use of a reference standard allows biomarker reporting to be normalized. Biomarker values can then be correlated from sample to sample and from laboratory to laboratory based on quantitative calibration on a universal reference standard.
Claims23
A method of selecting a therapeutic agent for treatment of a disease state in a patient, comprising:
- obtaining a cell sample from the patient, wherein the sample comprises cells characteristic of the disease state and the cells comprise one or more biomarkers;
- contacting the cells with a test compound that specifically binds to one or more biomarkers and comprises a fluorescent moiety;
- measuring the intensity of the fluorescence of the cells;
- and
- comparing the intensity of the fluorescence of the cells to a fluorescence intensity of a reference standard, wherein the ratio of the intensities correlates to the effectiveness of the therapeutic agent against the disease state.
A method of selecting a therapeutic agent for the treatment of cancer, comprising:
- obtaining a cell sample from a patient, wherein the sample comprises circulating cancer cells and said cancer cells comprise one or more biomarkers;
- contacting the cells with a test compound that specifically binds to one or more biomarkers and comprises a fluorescent moiety;
- measuring the intensity of the fluorescence of the cells;
- and
- comparing the intensity of the fluorescence of the cells to that of a reference standard, wherein the ratio of the intensities correlates to the effectiveness of the therapeutic agent against the cancer.
A kit for determining the susceptibility of a cancer cell to a therapeutic agent, comprising a targeting moiety coupled to a fluorescent moiety.
Dependencies are inferred from the claim text.