[gdpawel]

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 regards to Rational Therapeutics and Weisenthal Cancer Group, both use the functional profiling platform (just call it differently), It takes the tumor with the surrounding tissue intack and then puts chemo on it to see which chemos (actually) kill the cancer cells.

The ability to monitor cell "function" provides scientists with a vital method to characterize and compare activity of cells. Programmed cell death, or apoptosis, is critical in embryonic development, cancer formation, and lowering inflammatory response and is often used to determine if cells are functioning properly.

There is much research devoted to measuring gene expression. A key challenge is differentiating changes in gene expression caused by changes in primary DNA sequence, versus those caused principally by modifications to histones and methylation of DNA.

Understanding the structural and functional relationships of cells and tissues is critical to advancements in key research disciplines, including molecular biology, genetics, reproductive function, immunology, cancer and neurobiology.

Now that the human genome has more or less been sequenced and the technologies developed to analyze numerous genes and gene products simultaneously (microarray technologies), the focus of scientific query will switch from simply identifying the gene/protein to investigating the function(s) and inter-relationships between specific gene products and specific cellular activities (drug selection).

No technology is more well suited to the investigation and simultaneous analysis of the relationships between specific target molecules, cell functions and cell sub-populations than cytometry and cytometric analysis of cell phenotype and function provides a very comprehensive overview of this ever-broadening field (function cytometric profiling).

And some inside information. Precision Therapeutics has a complement assay to their ChemoFx, which is run on a "population" of tumors. They identify the responsive, intermediately responsive, and nonresponsive patients. Then take the molecular markers and find out what these patients have in common with respect to 150 different genes.

Then they work on eliminating the genes that are irrelavent. What they get is a multi-gene predictor. It can't work without ChemoFx working. ChemoFx is the backbone of BioSpeciFx. The thing that is unique about BioSpeciFx is that the oncologist can pick and choose which markers he/she want to see. An ala carte selection if you will.

Caris' Target Now does not do this. In fact, they are running 100-120 different markers and charging for each one, with relatively no clinical relevancy to justify this.