System and method for determining individualized medical intervention for a disease state
Inventors
Von Hoff, Daniel D. • Penny, Robert J.
Assignees
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Publication Number
US-9383365-B2
Publication Date
2016-07-05
Expiration Date
Abstract
A system and method for determining individualized medical intervention for a particular disease state, and especially for cancers, that includes the molecular profiling of a biological sample from the patient, determining whether any molecular findings including one or more genes, one or more gene expressed proteins, one or more molecular mechanisms, and/or combinations of such exhibit a change in expression compared to a reference, and identifying a non-specific disease therapy or agent capable of interacting with the genes, gene expressed proteins, molecular mechanisms, or combinations of such molecular findings that exhibited a change in expression.
Core Innovation
The invention relates to a molecular-profiling-based, disease-lineage-independent system and method for determining individualized medical intervention for an individual with a cancer. Molecular profiling of biological sample(s) is performed to determine molecular profile test values for a plurality of molecular targets, including EGFR, KIT, TOP1, MLH1, PTEN, PDGFRA and ERBB2, and the molecular profile test values are used to generate individualized patient intervention information.
The system compares the molecular profile test values against a normal reference value for each of the plurality of molecular targets in order to identify significant expression changes and likely benefit relationships. Reference values are stored in at least one computer database, and a listing of available therapeutic agents is also stored for each molecular target.
A comparison indicating likely benefit is used to identify at least one therapeutic agent for the individual. A patient profile report is generated that includes a listing of the molecular targets for which the comparison to the reference value indicates a likely benefit of the at least one therapeutic agent, and the at least one therapeutic agent identified based on that comparison.
Claims Coverage
The independent claim covers an integrated report-generating system that assays a plurality of cancer molecular targets in a biological sample, compares molecular profile test values to reference values stored in databases, and identifies and reports at least one therapeutic agent predicted to likely benefit the individual based on the comparison. The inventive features center on multi-target molecular profiling, target-specific reference/value databases, comparison logic, therapeutic-agent identification logic, and report generation listing targets and agents.
Assaying a plurality of molecular targets including specified cancer targets
At least one device configured to assay a plurality of molecular targets in a biological sample to determine molecular profile test values for the plurality of molecular targets, wherein the plurality of molecular targets comprises EGFR, KIT, TOP1, MLH1, PTEN, PDGFRA and ERRB2.
Target-specific reference values and listings of therapeutic agents 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.
Comparing molecular profile test values to corresponding database reference values
Computer-readable program code comprising instructions to input the molecular profile test values and to compare each of the molecular profile test values with a corresponding reference value from the at least one computer database.
Identifying therapeutic agents based on comparison indicating likely benefit
Computer-readable program code comprising instructions to access the at least one computer database and to identify at least one therapeutic agent from the listing of available therapeutic agents for the plurality of molecular targets wherein the comparison to the reference values indicates a likely benefit of the at least one therapeutic agent.
Generating a report listing target(s) and identified therapeutic agent(s)
Computer-readable program code comprising instructions to 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.
Overall, the claim coverage ties together multi-target molecular profiling, database-stored reference values and therapeutic-agent listings, comparison to determine likely benefit, therapeutic-agent identification, and report generation listing both molecular targets and therapeutic agents.
Stated Advantages
Generates a patient profile report identifying at least one therapeutic agent for an individual with a cancer based on comparison of molecular profile test values to reference values.
Provides a listing of the molecular targets for which the comparison indicates a likely benefit of the identified therapeutic agent(s).
Documented Applications
Clinical decision support for individualized medical intervention by generating a report identifying therapeutic agents for an individual with a cancer using molecular profiling and database comparisons.
Drug therapy identification/validation within a host-server architecture using drug/gene/disease libraries and biospecimen tracking (LIMS).
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