Molecular profiling of tumors
Inventors
Von Hoff, Daniel D. • Loesch, David M. • Alarcon, Arlet • Penny, Robert J. • Wright, Alan • McGinniss, Matthew J. • Bender, Ryan P. • Pawlowski, Traci
Assignees
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Abstract
Provided herein are methods and systems of molecular profiling of diseases, such as cancer. In some embodiments, the molecular profiling can be used to identify treatments for a disease, such as treatments that were not initially identified as a treatment for the disease or not expected to be a treatment for a particular disease.
Core Innovation
The invention provides a system for generating a report identifying at least one therapeutic agent for an individual with colorectal cancer. The system uses at least one nucleic acid sequencing device configured to assay a plurality of molecular targets in a biological sample to determine molecular profile test values, and the plurality of molecular targets comprises BRAF, PIK3CA, EGFR and PTEN.
The system further includes at least one computer database comprising a reference value for each of the plurality of molecular targets and a listing of available therapeutic agents for each of the plurality of molecular targets. A computer-readable program code inputs the molecular profile test values and compares each molecular profile test value with a corresponding reference value from the database.
The comparison is used to identify at least one therapeutic agent in which the comparison indicates a likely benefit, and the system generates a report that comprises a listing of the molecular targets for which the comparison indicated a likely benefit of the at least one therapeutic agent and the at least one therapeutic agent identified. The document describes report logic and database mappings that relate biomarker states and test values to therapeutic benefit.
Claims Coverage
Independent claim coverage centers on a report-generating system for colorectal cancer that assays a plurality of molecular targets, compares molecular profile test values to reference values in a database, identifies therapeutic agents whose comparison indicates a likely benefit, and generates a report linking likely-benefit molecular targets to identified therapeutic agents. Four inventive features are recited.
Multi-target sequencing for molecular profile test values
At least one nucleic acid sequencing device configured to assay a plurality of molecular targets in a biological sample from the individual with colorectal cancer to determine molecular profile test values for the plurality of molecular targets, wherein the plurality of molecular targets comprises BRAF, PIK3CA, EGFR and PTEN.
Reference values and therapeutic agent listings in a computer database
At least one computer database comprising a reference value for each of the plurality of molecular targets and a listing of available therapeutic agents for each of the plurality of molecular targets.
Database-driven comparison of molecular profile test values to reference values
Input the molecular profile test values and compare each molecular profile test value with a corresponding reference value from the at least one computer database.
Report generation listing likely-benefit molecular targets and corresponding therapeutic agents
Generate a report that comprises a listing of the molecular targets for which the comparison to the reference value indicated a likely benefit of the at least one therapeutic agent and the at least one therapeutic agent identified.
The inventive concepts center on sequencing a defined plurality of molecular targets, using database-provided reference values and therapeutic agent listings, comparing test values to the reference values to indicate likely benefit, and generating a report that links likely-benefit molecular targets to identified therapeutic agents.
Stated Advantages
Improved progression free survival (PFS).
Improved disease free survival (DFS).
Improved overall survival (OS).
Lifespan extension.
Documented Applications
Identifying a therapeutic agent for an individual with colorectal cancer by generating a report based on molecular profile test values compared to reference values in a database.
Identifying likely lack of benefit for at least one additional therapeutic agent by generating a report that lists additional molecular targets where comparisons to a reference indicate a likely lack of benefit.
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