Standardized evaluation of therapeutic efficacy based on cellular biomarkers
OwnerStephen A. LESKO, Paul O.P. Ts'oinventors
Life of this patent
Estimating the term…
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.
Claims12
A method for predicting efficacy of a therapeutic agent, comprising:
- calibrating a first fluorescent microscope using a reference standard;
- calibrating a second fluorescent microscope using the reference standard;
- measuring a first reference standard intensity using the first fluorescent microscope;
- measuring a second reference standard intensity using the second fluorescent microscope;
- measuring a first sample intensity of a fluorescent binding moiety in a first sample using the first fluorescent microscope;
- measuring a second sample intensity of the fluorescent binding moiety in a second sample using the second fluorescent microscope,
- wherein the fluorescent binding moiety binds to one or more biomarkers that are associated with efficacy of the therapeutic agent;
- comparing the first sample intensity to the first reference standard intensity to determine a first efficacy of the therapeutic agent;
- and
- comparing the second sample intensity to the second reference standard intensity to determine a second efficacy of the therapeutic agent.
Dependencies are inferred from the claim text.