Report from AMP: "The Spectrum of Clinical Utilities in Molecular Pathology Testing Procedures for Inherited Conditions and Cancer"

The Association for Molecular Pathology (AMP) has set important standards for how clinical utility is defined and assessed as it relates to molecular diagnostic testing procedures for inherited conditions and cancer. The report, published in the September issue of The Journal of Molecular Diagnostics (JMD), recommends a fundamental shift to achieve the proactive, patient-centered approach necessary for modern healthcare.

In the manuscript, the AMP Framework for the Evidence Needed to Demonstrate (FEND) Clinical Utility task force makes numerous specific recommendations in the following areas:

• Adopting patient-centered definitions of clinical utility
• Recognizing an accurate diagnosis has inherent clinical utility
• Recognizing that clinical utility for molecular diagnostics is context dependent
• Supporting multiple modalities of evidence generation, including appropriate alternatives to randomized clinical trials
• Utilizing a modified ACCE Model
• Recognizing the critical role of the molecular professional
• Supporting professional organization-driven practice guidelines