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Feasibility study with US Oncology Research will evaluate the practicality of multiple biomarker testing
Calling the concept “pre-profiling,” Quintiles (Research Triangle Park, NC) is collaborating with US Oncology Research (the research arm of McKesson Specialty Health) to test the value of running multiple biomarker tests at once for cancer patients—in this case those with metastatic colorectal cancer (mCRC). Either for initial therapy, or as a step to selecting candidates for clinical trials, the current practice is to look for genomic data that is relevant to one type of therapy; if the suitable genomic variant is found, the clinician then knows that the patient is a good trial candidate, or that the patient could benefit from a specific therapy. Quintiles is suggesting to look at many variants or makers initially and then make treatment or trial recruitment decisions.
In practice, says Dr. Jeffrey Spaeder, CMO at Quintiles, a biopsy would be retrieved from the patient, DNA and other genomic information sequenced, abnormalities identified, and bioinformatics analysis conducted, then returning the results back to the clinician. “All these steps sound intuitively straightforward, but they involve complex handoffs of information and clinical decisions,” he says. Understanding what the clinician can do with the data needs to be determined; what choices the patient might have for one therapy or another; and in the final analysis, whether better outcomes could be achieved remain to be evaluated. Eventually, the multiple-biomarker process could become a step in the clinical pathways that various organizations have developed for treatment of cancers. “Early indications from this study suggest that we can provide physicians and patients with early visibility on potentially clinically actionable biomarkers within a rapid two-week timeframe. This level and speed of analysis has promise to save valuable time in administering potentially life-saving therapies to patients, and reduce the development times of precision medicines.”
The biomarker field, while demonstrating exciting new potential and spurring the evolution of personalized (or “precision”) medicine, is fraught with operational difficulties. Insurers are selective about what biomarker tests they are willing to pay for; practitioners have varying enthusiasm for the tests, and the clarity around which tests lead to beneficial outcomes are not clear. Even so, this study could be one of a series of medical innovations to make biomarkers a standard element of cancer therapy.