Ventana Medical Systems, Inc.

The Cleveland Clinic Foundation

The University of Melbourne

Crystal Schemp

Shalini Singh

Michael S Barnes

Thomas M Grogan

Esteban Roberts

Penny Towne

Hiro Nitta

June F Clements

Srinivas Chukka

Anindya Sarkar

Olcay Sertel

Raymond Tubbs

Paul Waring

Nikolaus Wick

Paul Michael Waring

Michael Barnes

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.

Method of identifying treatment responsive non-small cell lung cancer using anaplastic lymphoma kinase (ALK) as a marker

Heterogeneity for biomarkers in a tissue sample can be calculated. A heterogeneity score can be combined with an immunohistochemistry combination score to provide breast cancer recurrence prognosis. Heterogeneity can be based on percent positivity determinations for a plurality of biomarkers according to how many cells in the sample stain positive. An immunohistochemistry combination score can be calculated. An imaging tool can support a digital pathologist workflow that includes designating fields of view in an image of the tissue sample. Based on the fields of view, a heterogeneity metric can be calculated and combined with an immunohistochemistry combination score to generate a breast cancer recurrence prognosis score.

Image analysis for breast cancer prognosis

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 (IBC) 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.

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Tucson, AZ, United States of America

Crystal Schemp