In regards to the Caris Target Now, it is a tumor analysis coupled with clinical literature search, which matches therapies to patient-specific biomarker information to generate a treatment approach. Caris Target Now testing provides information that may help when considering "potential" treatment options.
Caris Target Now begins with an immunohistochemistry (IHC) analysis. An IHC test measures the level of proteins in cancer cells providing clues about which therapies are "likely" to have clinical benefit and "then what additional tests should be run." They never actually test your tumor specimen against any drug agents.
If there is access to a frozen sample of patient tissue available, Caris Life Sciences may also run a gene expression analysis by microarray. The microarray test looks for genes in the tumor that are associated with treatment options. IHC testing examines "dead" tissue. One gets more accurate information when using intact RNA isolated from "live" fresh tissue than from using degraded RNA, which is present in paraffin-fixed tissue.
As deemed appropriate based on each patient, Caris will run additional tests. Fluorescent In-Situ Hybridization (FISH) is used to examine gene copy number variation in the tumor. Polymerase Chain Reaction (PCR) or DNA sequencing is used to determine gene mutations in the DNA tumor.
Caris takes the results from each test and applies the published findings from thousands of clinical trials. Based on this analysis, Caris Target Now identifies "potential" therapies for patients and their treating physicians to discuss. Again, never measuring any of the therapies against your individual cancer cells.
Caris Target Now was developed and its performance characteristics were determined by Caris Life Sciences, a medical laboratory CLIA-certified in compliance with the U.S. Clinical Laboratory Amendment Act of 1988 and all relevant U.S. state regulations. It has not been approved by the United States Food and Drug Administration. It says it right on the report.
Their molecular profiling need only obtain a small biopsy of tissue to identify the targets "most likely" to respond to available agents. However, their investigators invented a criterion of response: 1.3 fold improvement in time to progression. Patients who receive an ineffective therapy and showed disease progression, need only improve upon that short response by a mere 30% to be counted among the responders. No wonder none of the molecular assay results make sense.
A patient who fails a therapy after 10 days could theoretically be counted among the successes if their subsequent response to directed therapy was a meager 13 days in duration (J Clin Oncol 28:4877-4883. 2010). The NCI has concluded (J Natl Cancer Inst. March 16, 2010), molecular tests cannot determine treatment plans for patients. It cannot test sensitivity to any of the targeted therapies. It just tests for "theoretical" candidates for targeted therapy.
In fact, they are running 100-120 different markers and charging for each one, with relatively no clinical relevancy to justify this.