Quintiles, a North Carolina-based provider of biopharmaceutical development and outsourcing services, announced that it will conduct a study to explore how pre-profiling and genomic sequencing data could help physicians identify appropriate new treatments and clinical trials for cancer patients, according to a statement released by the company on Tuesday.
The study, entitled “Feasibility Study of Biomarker Analysis for Patients with Metastatic Colorectal Cancer,” will be conducted in partnership with US Oncology Research and with support by McKesson Specialty Health and The US Oncology Network. The objective is to determine the number of genetic changes that occur within mCRC patients that are targeted by FDA-approved therapies, as well as those targeted by therapies in development. The study will perform a broad-based biomarker analysis on mCRC patients, and the results will be reported to the treating physicians.
“Today, the industry’s approach to stratifying patients through genomic screening is sequential – testing for oncology biomarkers one at a time, and often only as part of screening for participation in a single clinical trial,” Jeffrey Spaeder, M.D., chief medical and scientific officer for Quintiles, said in the statement. “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.”
According to the company, pre-profiling may accelerate early testing of new biomarker-targeted therapies by allowing researchers to focus on molecules with high potential for safety and effectiveness, thus, enabling the efficient matching of the right patients to the right clinical studies. “Our work is taking a critical step toward making precision medicine a reality,” Spaeder said.
Other biopharmaceutical companies that have studied or are making use of pre-profiling include India-based GVKBIO and London-based AstraZeneca, according to Outsourcing-Pharma.com. Spaeder told the online news service earlier this year that some biomarker analysis hasn’t always been successful, but “we needed them for earlier assessments of efficacy and safety and to make go and no decisions.”
Edited by
Alisen Downey
