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Robin K. Kelley, Chloe Atreya, Alan P. Venook and Phillip G. Febbo

Because of a surge in molecular testing capabilities concurrent with the rising numbers of targeted therapies in clinical development, the commercial use of predictive biomarkers before clinical validation is available is a topic of growing relevance to medical oncologists. Increasingly, patients will present questions about, requests for, and results from commercial biomarker tests for their oncologists to address. The sheer numbers of tests reaching the market, along with forecasted American Medical Association reforms in current procedural terminology coding and increasing FDA oversight of in vitro companion diagnostic device development, are likely to draw intense scrutiny to the regulation of commercial molecular testing in the near future, which will also require clinicians to remain abreast of the level of clinical validation of the biomarker tests available in practice. In addition to the direct risks of novel biomarker testing, including financial cost and ethical issues, the indirect risks encompass those associated with any clinical decision based on the biomarker test results. A great need exists for comprehensive and dynamic practice guidelines for all types of biomarker testing according to tumor type.

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Paul F. Engstrom, Mara G. Bloom, George Daniel Demetri, Phillip G. Febbo, William Goeckeler, Marc Ladanyi, Bryan Loy, Kate Murphy, Michael Nerenberg, Paul Papagni, Mark Robson, Robert W. Sweetman, Sean Tunis, Jessica DeMartino and Jonathan K. Larsen

Personalized medicine in oncology is maturing and evolving rapidly, and the use of molecular biomarkers in clinical decision-making is growing. This raises important issues regarding the safe, effective, and efficient deployment of molecular tests to guide appropriate care, specifically regarding laboratory-developed tests and companion diagnostics. In May 2011, NCCN assembled a work group composed of thought leaders from NCCN Member Institutions and other organizations to identify challenges and provide guidance regarding molecular testing in oncology and its corresponding utility from clinical, scientific, and coverage policy standpoints. The NCCN Molecular Testing Work Group identified challenges surrounding molecular testing, including health care provider knowledge, determining clinical utility, coding and billing for molecular tests, maintaining clinical and analytic validity of molecular tests, efficient use of specimens, and building clinical evidence.

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Phillip G. Febbo, Marc Ladanyi, Kenneth D. Aldape, Angelo M. De Marzo, M. Elizabeth Hammond, Daniel F. Hayes, A. John Iafrate, R. Kate Kelley, Guido Marcucci, Shuji Ogino, William Pao, Dennis C. Sgroi and Marian L. Birkeland

The molecular analysis of biomarkers in oncology is rapidly advancing, but the incorporation of new molecular tests into clinical practice will require a greater understanding of the genetic changes that drive malignancy, the assays used to measure the resulting phenotypes and genotypes, and the regulatory processes that new molecular biomarkers must face to be accepted for clinical use. To address these issues and provide an overview of current molecular testing in 6 major malignancies, including glioma, breast cancer, colon cancer, lung cancer, prostate cancer, and acute myelogenous leukemia, an NCCN Task Force was convened on the topic of evaluating the clinical utility of tumor markers in oncology. The output of this meeting, contained within this report, describes the ways biomarkers have been developed and used; defines common terminology, including prognostic, predictive, and companion diagnostic markers, and analytic validity, clinical validity, and clinical utility; and proposes the use of a combination level of evidence score to aid in the evaluation of novel biomarker tests as they arise. The current state of regulatory oversight and anticipated changes in the regulation of molecular testing are also addressed.