MOLECULAR PROFILING OF TUMORS
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.
1 . A system for generating a report identifying a therapeutic agent for an individual with lung cancer comprising:
a. at least one nucleic acid sequencing device configured to assay a plurality of molecular targets in a biological sample from the individual to determine molecular profile test values for the plurality of molecular targets, wherein the molecular targets comprise BRAF, EGFR, PDGFRA, and PI3K;
b. at least one computer database comprising:
i. a reference value for each of the plurality of molecular targets;
ii. a listing of available therapeutic agents for the plurality of molecular targets;
c. a computer-readable program code comprising instructions to input the molecular profile test values and to compare the molecular profile test values with a corresponding reference value from the at least one computer database in (b)(i);
d. a 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 in (c) indicates a likely benefit of the at least one therapeutic agent; and
e. a computer-readable program code comprising instructions to generate a report that comprises a listing of all the molecular targets for which the comparison to the reference value indicated a likely benefit of the at least one therapeutic agent in (d) and the at least one therapeutic agent identified in (d).
2 . The system of claim 1 , wherein the molecular profile test values are input into the system from a location that is remote from the at least one computer database.
3 . The system of claim 1 , wherein the molecular profile test values are input into the system over an internet connection.
4 . The system of claim 1 , wherein the report is in electronic or paper format.
5 . The system of claim 1 , wherein the at least one computer database further comprises data corresponding to at least one clinical trial of a molecular target.
6 . The system of claim 1 , wherein the reference value for each of the plurality of molecular targets comprises a nucleic acid sequence.
7 . The system of claim 1 , wherein the test values for the plurality of molecular targets are determined after the individual has received drug therapy for the lung cancer.
8 . The system of claim 1 , wherein the molecular profile test values are determined by assessing a cell, tissue sample, blood sample or combination thereof.
9 . The system of claim 1 , wherein the molecular profile test values are determined by performing a test for a gene and/or protein.
10 . The system of claim 1 , wherein each reference value is obtained from at least one normal individual without lung cancer.
11 . The system of claim 1 , wherein the individual has been treated by and failed to respond to at least one cancer therapeutic.
12 . The system of claim 1 , wherein the report further comprises a listing of at least one additional molecular target for which the comparison to the reference value indicates a likely lack of benefit of at least one additional therapeutic agent and the at least one additional therapeutic agent.
13 . The system of claim 1 , further comprising a computer-readable program code comprising instructions to prioritize the list of the at least one therapeutic agent.
14 . The system of claim 1 , wherein the report provides a prioritized list of the at least one therapeutic agent.
15 . The system of claim 1 , wherein the molecular target EGFR is further assessed by protein testing.
16 . The system of claim 1 , wherein the plurality of molecular targets further comprises MGMT and/or AR.
17 . The system of claim 16 , further comprising determining molecular profile test values using immunohistochemistry of the molecular targets PDGFRA, EGFR, MGMT and AR.
18 . The system of claim 1 , wherein the molecular targets PDGFRA and EGFR are further assessed by protein testing.
19 . The system of claim 1 , wherein the at least one nucleic acid sequencing device is configured to perform at least one of polymerase chain reaction (PCR), pyrosequencing, real-time PCR, Sanger sequencing, NextGen sequencing, methylation specific PCR (MSPCR), restriction fragment length polymorphism (RFLP analysis), a single nucleotide polymorphism (SNP) microarray, in-situ hybridization (ISH), fluorescent in-situ hybridization (FISH), and a proteomic array.
20 . The system of claim 1 , wherein the at least one nucleic acid sequencing device is configured to identify at least one of a mutation, polymorphism, deletion, insertion, substitution, translocation, fusion, break, duplication, amplification or repeat in a nucleic acid sequence corresponding to each of the plurality of molecular targets.