Flagship Biosciences, Inc.

Joshua C Black

Joseph Krueger

Nathan T Martin

Holger Lange

Logan Jerome Cerkovnik

Cris L Luengo Hendriks

Famke Aeffner

Kristin Wilson

Carsten Schnatwinkel

One type of tissue-based assay, the companion diagnostic ('CDx') allows for the identification of individuals within a larger patient population who are more likely to respond to a therapy. The CDx paradigm typically applies to drugs that target a specific gene product or biologic pathway involving a gene product of interest. It is possible, especially for popular therapeutic targets, for multiple drugs and multiple associated CDx to be developed for a single gene product or biologic pathway involving the gene product. Currently, each of these similar CDx must be applied to identify the best therapy. The present invention can determine the outcome of one CDx using an image of a tissue section used for another CDx. Using a single tissue section and a single CDx, it becomes possible to obtain the outcome of multiple, related CDx.

Method for digitally generating scores for multiple diagnostic tests from tissue assayed with a single test

The disclosure concerns a method for extracting geographic distribution statistics from patient tissue samples assayed with a tissue-based test for the purpose of scoring the patient tissue samples and guiding treatment based on the score(s). The method described herein utilizes digital image analysis of an image of one or more tissue sections to extract object-based (e.g., cells) features to generate a data array representing said tissue numerically in image analysis feature space. The numerical representation of the image of the tissue section in image analysis feature space is further processed using one or more algorithm processes to extract sophisticated geographical distribution features of one or more object type or sub-type in the tissue. Statistics describing the geographic distribution features are summarized to generate a patient-specific diagnostic score, and this score can be evaluated to guide patient treatment decisions.

Method for scoring pathology images using spatial statistics of cells in tissues

The disclosure concerns a method for patient stratification and selection of patients who are candidates for a specific therapy is described which is based on quantifying one or more digital image analysis feature distributions from stained tissue. The method extends beyond the abilities of a manual observer and a microscope, and generally comprises: acquiring digital images of stained tissue sections from patients submitted for evaluation, applying an algorithm process to said images with a computer to extract the morphometric and staining features of image pixels and tissue objects, deriving one or more distribution function for one or more image analysis features, calculating a summary statistic of the one or more distribution functions, and using said summary statistic along with an associated predefined patient stratification paradigm to separate a patient cohort into distinct strata which correspond to a decision to include or exclude a patient for a specific therapy.

Method for stratifying and selecting candidates for receiving a specific therapeutic approach

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Aurora, CO, United States of America

Joshua C Black