NCCN Task Force Report: Evaluating the Clinical Utility of Tumor Markers in Oncology

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.

Target Audience

This educational program is designed to meet the needs of oncologists, advanced practice nurses, and other clinical professionals who treat and manage patients with cancer.

Learning Objectives

After completion of this CME/CE activity, participants should be able to:

  • Distinguish between a prognostic factor and a predictive factor as they apply to oncology
  • Define the term “clinical utility” as it applies to the incorporation of tumor markers into clinical practice guidelines
  • Describe the factors considered in the evaluation of the clinical utility of a tumor marker in oncology
  • Describe the complementary roles played by pathologists and clinicians in ensuring accurate testing of tumor markers
  • Explain the difference between the terms “laboratory certification” and “laboratory accreditation” as they apply to pathology laboratories performing tumor marker testing
  • Describe the importance of pathologic expertise, internal quality control standards, and external quality assurance monitoring in determining the reliability of tumor marker testing
  • Explain the significance of FDA approval as it applies to a diagnostic test
  • Summarize initiatives for transitioning basic and translational research findings on tumor markers into clinical practice
Additional information

The distribution of this task force report is supported by educational grants from Dendreon Corporation, Genomic Health, Inc., Genoptix Medical Laboratory, and Pfizer.

The National Comprehensive Cancer Network® (NCCN®) appreciates that supporting companies recognize NCCN’s need for autonomy in the development of the content of NCCN resources. All NCCN content is produced completely independently. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) are not intended to promote any specific therapeutic modality.

Course summary
Available credit: 
  • 0.75 Participation
  • 0.75 Nurse
  • 0.75 Physician
Course opens: 
Course expires: 

Phillip G. Febbo, MD/Co-Chair
UCSF Helen Diller Family Comprehensive Cancer Center

Marc Ladanyi, MD/Co-Chair
Memorial Sloan-Kettering Cancer Center

Kenneth D. Aldape, MD
The University of Texas MD Anderson Cancer Center

Robert L. Becker, Jr., MD, PhD
U.S. Food and Drug Administration

Marian Birkeland, PhD
National Comprehensive Cancer Network

Barbara Conley, MD
National Cancer Institute

Angelo M. De Marzo, MD, PhD
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

M. Elizabeth Hammond, MD
Huntsman Cancer Institute at the University of Utah

Daniel F. Hayes, MD
University of Michigan Comprehensive Cancer Center

A. John Iafrate, MD, PhD
Massachusetts General Hospital and Harvard Medical School

R. Kate Kelley, MD
UCSF Helen Diller Family Comprehensive Cancer Center

Guido Marcucci, MD
The Ohio State University Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute

Shuji Ogino, MD, PhD, MS
Dana-Farber Cancer Institute; Brigham and Women’s Hospital; Harvard Medical School

William Pao, MD, PhD
Vanderbilt-Ingram Cancer Center

Dennis C. Sgroi, MD
Massachusetts General Hospital

Available Credit

  • 0.75 Participation
  • 0.75 Nurse
  • 0.75 Physician


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