Patent Document ID: 9785752
Application ID: 14986512
Patent Flag: 1

Claim One:
1. A method or stratifying and selecting candidates for receiving a specific therapeutic approach, the method comprising: a. obtaining digital images of stained tissue sections mounted on glass slides; b. identifying one or more regions of analysis (ROAs); c. extracting data associated with one or more staining and morphometric features, said features including one or more of: image pixels, cell objects, and tissue structure objects within each digital image, wherein said extracting includes applying a digital image analysis algorithm process implemented by a computer for each image; d. storing the data for each cell or tissue structure in computer memory or a database; e. visualizing the distribution of one or more of the staining or morphometric feature data analyzed by the algorithm process implemented by the computer; f. calculating a function which captures the distribution of data for one or more staining or morphometric features for all of the analyzed pixels, cells objects or tissue structure objects within one of the ROAs; g. deriving a summary score for the function which captures the distribution for said one or more staining or morphometric features; h. evaluating said summary score relative to one or more pre-defined reference values and associated patient stratification and selection criteria; and i. selecting a patient as a candidate for a specified therapy based on said evaluation of a summary score value relative to the reference values and accompanying selection criteria, wherein the tissue is stained for a single biomarker or multiple biomarkers within the same tissue section or in multiple tissue sections from the same patient and wherein the morphometric and staining features are evaluated by the algorithm process in an object-based or pixel-based manner.