Recorded Presentation from the NCCN 2017 Congress Series™: Biomarkers 101 - What Are Biomarker Tests and How Are They Approved?

Join Long Phi Le, MD, PhD, Massachusetts General Hospital for this webinar What Are Biomarker Tests and How Are They Approved? in the NCCN 2017 Congress Series™: Biomarkers 101.

The science and practice of oncology are rapidly evolving based on more complete knowledge of cancer genomes and the specific genetic events that drive cancer. This knowledge, coupled with advances in medicinal chemistry, has ushered in an era of precision oncology. Use of molecular testing followed by therapies tailored to the particular molecular landscape of a patient’s disease can allow appropriate therapies to be given to patients who are most likely to benefit, while avoiding unnecessary treatment of patients who are unlikely to benefit.  Although the availability of new cancer biomarkers is encouraging for diagnosis, prognosis and treatment decision-making, determining the clinical usefulness and selection of the appropriate testing methodologies can represent a daunting challenge for practitioners.  With the field of biomarkers rapidly advancing, clinical research directly affects how oncologists manage patients. Keeping up with advances in biomarker testing allows clinicians to offer state-of-the-art care to their patients with cancer and to better identify patients that are appropriate for biomarker-directed clinical trials.

Target Audience

This educational program is designed to meet the educational needs of oncologists, nurses, pharmacists, and other healthcare professionals who manage patients with cancer.

Learning Objectives

Following this activity, participants should be able to:

  • Distinguish between diagnostic, prognostic, and predictive biomarkers in oncology.
  • Describe several different biomarker testing methodologies.
  • Explain the significance of FDA approval, Clinical Laboratory Improvement Amendments (CLIA) approval, and Molecular Diagnostic Services Program (MolDX) coverage recommendations as they apply to biomarker tests in oncology.
Additional information

This activity is supported by educational funding provided by Amgen.

This activity is supported by independent educational grants from AbbVie and Merck & Co., Inc.

This activity is supported by an independent medical education grant from Bristol-Myers Squibb.

This activity is supported by educational grants from:

  • AstraZeneca
  • Daiichi Sankyo, Inc.
  • Foundation Medicine
  • Genomic Health, Inc.
  • Lilly
  • Novartis
Course summary
Available credit: 
  • 1.00 ACPE contact hours
  • 1.00 AMA PRA Category 1 Credit™
  • 0.93 ANCC contact hours
  • 1.00 Participation
Course opens: 
Course expires: 

Long Phi Le, MD, PhD
Massachusetts General Hospital


Disclosure of Relevant Financial Relationships
All faculty and activity planners participating in NCCN continuing education activities are expected to disclose any relevant financial relationships with a commercial interest as defined by the ACCME’s, ANCC’s, and ACPE’s Standards for Commercial Support. All faculty presentations have been reviewed for adherence to the ACCME’s Criterion 7: The provider develops activities/educational interventions independent of commercial interests (SCS 1, 2, and 6) by experts on the topics. Full disclosure of faculty relationships will be made prior to the activity.

The faculty listed below discloses the following relevant financial relationships:
Long Phi Le, MD, PhD
ArcherDX, Inc.: Consulting Fees, Honoraria; Equity Interest/Stock Options

The NCCN Activity Planning staff listed below discloses no relevant financial relationships:
Kim Bayer; Melissa Esplen; Mark Geisler; Kristina M. Gregory, RN, MSN, OCN; Kristin Kline Hasson; Donald Harting, ELS, CHCP; Rose Joyce; Karen Kanefield; Lisa Kimbro, MBA, CPA; Rashmi Kumar, PhD; Joan S. McClure, MS; Diane McPherson; Deborah Moonan, RN, BSN (employed by NCCN until 2/7/17); Melanie Moletzsky; Heather Matt; Lisa Perfidio; Liz Rieder; Shannon K. Ryan; Kathy Smith; Melinda Somasekhar, PhD (employed by NCCN until 10/30/17)

The NCCN Clinical Information staff listed below, who has reviewed content, discloses no relevant financial relationships:
Deborah Freedman-Cass, PhD; Lisa Gurski, PhD

The NCCN Compendia Program staff listed below discloses no relevant financial relationships:
Marian Birkeland, PhD

The ACCME/ANCC/ACPE defines “conflict of interest” as when an individual has an opportunity to affect CE content about products or services of a commercial interest with which he/she has a financial relationship.

ACCME, ACPE, and ANCC focuses on financial relationships with commercial interests in the 12-month period preceding the time that the individual is being asked to assume a role controlling content of the CE activity. ACCME, ACPE, and ANCC have not set a minimal dollar amount for relationships to be significant. Inherent in any amount is the incentive to maintain or increase the value of the relationship. The ACCME, ACPE, and ANCC defines “relevant’ financial relationships” as financial relationships in any amount occurring within the past 12 months that create a conflict of interest.

All faculty for this continuing education activity are competent in the subject matter and qualified by experience, training, and/or preparation to the tasks and methods of delivery.

Faculty presentations may include discussion of off-label use.  Faculty will disclose that the use in question is not currently approved by the FDA per the product labeling.

National Comprehensive Cancer Network (NCCN) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

NCCN designates this enduring material for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Physician Assistants
AAPA accepts certificates of participation for educational activities certified for AMA PRA Category 1 Credit™ from organizations accredited by ACCME or a recognized state medical society. PAs may receive a maximum of 1.0 hour of Category I credit for completing this activity.

National Comprehensive Cancer Network (NCCN) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.

NCCN designates this educational activity for a maximum of 0.93 contact hours.


National Comprehensive Cancer Network (NCCN) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

NCCN designates this knowledge-based continuing education activity for 1.0 contact hour (0.1 CEUs) of continuing education credit. UAN: 0836-0000-17-117-H01-P

Available Credit

  • 1.00 ACPE contact hours
  • 1.00 AMA PRA Category 1 Credit™
  • 0.93 ANCC contact hours
  • 1.00 Participation


Please login or register to take this course.

Required Hardware/software

To complete this activity, users will need:

  • A device with an Internet connection and sound playback capability
    • One of the two latest versions of Google Chrome, Mozilla Firefox, or Safari
    • Internet Explorer is no longer supported
  • Adobe Reader or other PDF reader software for certificate viewing/printing