Comprehensive gene panel testing, one of the exciting new tools in cancer diagnostics, warrants greater scrutiny—as does a federal program aimed at speeding up the review process for proposed new medical technologies. Those are the conclusions of Yale medical experts who studied both and published a report in the JNCI: Journal of the National Cancer Institute on Sept. 18.
"Over the past decade, we have seen tremendous technological leaps forward in the realm of genetic testing and cancer ," said senior author Dr. Cary P. Gross, professor of medicine and of epidemiology, and director of Cancer Outcomes, Public Policy and Effectiveness Research (COPPER) Center, part of Yale Cancer Center at Yale School of Medicine.
"We can now test a tumor sample for hundreds of genetic mutations at a time," Gross said. "In some ways, our ability to develop powerful new testing technologies has leap-frogged ahead of our ability to determine whether they are helping people. "This is a particularly important issue now, because new genetic tests are being developed not only for patients with cancer, but as an approach to screening healthy patients.
" In the report, the Yale researchers evaluated 113 peer-reviewed scientific studies cited in support of the Centers for Medicare and Medicaid Services (CMS) decision to follow the Food and Drug Administration (FDA) in approving a new genomic profiling platform. CMS approval meant it would cover comprehensive genomic profiling as part of treatment for .