Recent definitions for clinical utility of molecular tests focus on whether a test result will alter treatment. This definition neglects other uses of molecular testing to diagnose disease, manage symptoms, prognosticate or predict future disease. The fullest realization of precision medicine will require embracing all aspects of clinical utility. This three-part webinar series, supported by AMP, presents the discussions of AMP’s Framework for the Evidence Needed to Demonstrate Clinical Utility (FEND) working group, and its resulting publication, “The Spectrum of Clinical Utilities in Molecular Pathology Testing Procedures for Inherited Conditions and Cancer: A Report of the Association for Molecular Pathology” (Joseph L, et al. J Mol Diagn. 2016;18[5]:605–619).

 

Part 1 - An Overview of AMP’s Framework for the Evidence Needed to Demonstrate Clinical Utility

Speakers: Loren Joseph, MD; Elaine Lyon, PhD

Host: Roger Klein, MD, JD

 

Part 2 - AMP’s Framework for the Evidence Needed to Demonstrate Clinical Utility – Oncology Cases

Speakers: Pranil Chandra, DO, FCAP, FASP; Rajyasree Emmadi, MD, FCAP

Host: Loren Joseph, MD

 

Part 3: AMP’s Framework for the Evidence Needed to Demonstrate Clinical Utility – Inherited Conditions

Speakers: Stephanie Hallam, PhD, FACMG, MBA; Victoria Pratt, PhD, FACMG

Host: Elaine Lyon, PhD

 

Total Duration: 3 hr

 

Note: Members of AMP can access this webinar at no cost. Join the AMP Family!

Course Information
Course Date:
September 28, 2016
Course Objectives
  • Discuss how different definitions of clinical utility apply to molecular tests.
  • Discuss the utility of testing in the absence of an established treatment plan.
  • Describe a modified ACCE model for determining clinical utility for genetic tests.
  • List types of evidences that demonstrate clinical utility.
  • Discuss the background and future of cancer genomics testing.
  • Recognize the breadth of clinical utility in the molecular testing of solid tumors and hematologic malignancies.
  • Recognize the limitations of current definitions of clinical utility for inherited conditions.
  • Define clinical validity and utility for inherited conditions.
  • Identify the efficiencies and economies of molecular oncology testing.
  • Identify a more inclusive view of clinical utility for inherited conditions.
An Overview of AMP's Framework for the Evidence Needed to Demonstrate Clinical Utility

This webinar discusses the current landscape of definitions for clinical utility, and then present a modified Analytical Validity, Clinical Validity, Clinical Utility and Associated Ethical, Legal and Social Implications (ACCE) framework. With this model the speakers explore the spectrum of clinical utilities, and evidences needed to demonstrate utility for all stakeholders, with a focus on patient-centered utility.

 

Speakers: Loren Joseph, MD; Elaine Lyon, PhD

Duration: 1.0hr

Level of Instruction: Basic

 

Speaker Information
Birgit Funke PhD, FACMG
Elaine Lyon PhD  [ view bio ]
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AMP's Framework for the Evidence Needed to Demonstrate Clinical Utility - Oncology Cases

The spectrum of clinical utility in solid tumor and hematologic malignancies will be discussed, focusing on diagnostic, prognostic, predictive and therapeutic options. In addition, the importance of diagnosis in the absence of an established treatment plan and the overall efficiency to the health care system will also be addressed.

 

Speakers: Pranil Chandra, DO, FCAP, FASP; Rajyasree Emmadi, MD, FCAP

Duration: 1.0hr

Level of Instruction: Intermediate

 

Speaker Information
Pranil Chandra DO, FCAP, FASP  [ view bio ]
Rajyasree Emmadi MD, FCAP  [ view bio ]
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Part 2
AMP Regular Member: $0.00
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Non-member Price: $195.00
AMP's Framework for the Evidence Needed to Demonstrate Clinical Utility - Inherited Conditions

This webinar will focus on an understanding of clinical utility in molecular pathology testing for inherited disease. We will review the limitations of the clinical utility models as they are currently defined and applied. We will then discuss a more comprehensive and pragmatic view that ensures appropriate access to care for those with inherited conditions.

 

Speakers: Stephanie Hallam, PhD, FACMG, MBA; Victoria Pratt, PhD, FACMG

 

Duration: 1.0hr

Level of Instruction: Intermediate

 

Speaker Information
Stephanie Hallam PhD, FACMG, MBA  [ view bio ]
Victoria Pratt PhD, FACMG  [ view bio ]
Tags
Newborn screening
Carrier screening
Pharmacogenomics
Hereditary Cancer Syndromes
Deafness
hearing loss
Neurologic disease
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Part 3
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Non-member Price: $195.00
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