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As Number of Targeted Cancer Drugs Grows, Commentary in JCO Precision Oncology Proposes Expanded Definition of Clinical Utility for Genetic Testing in Cancer Care

In a commentary article published yesterday in JCO Precision Oncology, authors Daryl Pritchard, Ph.D., of the Personalized Medicine Coalition, Clifford Goodman, Ph.D., of the Lewin Group, and Lincoln Nadauld, M.D., Ph.D., of Intermountain Healthcare, advocate for an updated definition of clinical utility for genetic testing in cancer care to account for a wider scope of benefits and risks that accrue from the use of more comprehensive genomic tests.

Although more than 90 cancer therapies on the market and 55 percent of cancer drugs in development involve biomarker-based strategies, studies show that many cancer patients never receive wide-ranging genomic tests that can shed light on the full scope of their treatment options. Data also indicate that only 60 – 75 percent of patients who test positive for actionable genetic mutations receive the targeted treatments indicated by their test results. By acknowledging a wider range of purposes for genomic sequencing, the recommendations in the article, if widely adopted, should prompt changes to the ways in which genomic sequencing-based tests are used in clinical settings.

In their commentary article, Pritchard and his co-authors report on a roundtable discussion including 18 leaders from multiple sectors of the health care system. The group acknowledged the importance of understanding how genomic sequencing can improve clinical outcomes, which are the focus of previous definitions of clinical utility. But in the cancer context, the group concluded that genomic sequencing also delivers population benefits associated with data compilation and analysis; better access to prevention and treatment strategies; and more opportunities for shared decision-making between patients and their providers.

“This watershed paper underlines the importance of integrating a more comprehensive definition of clinical utility into clinical care to better serve the interests of cancer patients and the future of research in this rapidly evolving era of personalized medicine,” said PMC President Edward Abrahams.