Genomics and Next-Generation Sequencing

Knowledge of the human genome is expanding and technologies supporting it are improving both in accuracy and speed. This combination of improved technology and knowledge will allow genomic medicine to become an integral part of clinical practice.

Pathologists are critical to integrating laboratory-based genomic diagnostics into clinical practice. As genomic medicine evolves, the CAP believes it will become a cornerstone of medical diagnostics, requiring specialized medical knowledge in test selection, interpretation and integration of test results with patients' medical history.

The CAP's Council On Government and Professional Affairs (CGPA) is working to advance the organization’s genomic strategic goals, in particular, ensuring a conducive operating environment and sufficient economic incentives for genomic testing. A cross-council workgroup comprised of the CGPA and Council on Scientific Affairs has been formed to focus on genomic issues and is working to address many of the challenges including (but not limited to) research limitations posed by regulatory and payment uncertainty, precision medicine, and evidence generation.

Ongoing Efforts

The CAP believes genomic medicine is a continuation of pathologists’ practice of medicine, and impacts all areas of pathology. We are working to assure that pathologists may continue to practice medicine in the best interest of their patients.

Learn more on the CAP's advocacy and read comments to regulatory agencies on genomic issues.

• CMS Addresses the CAP’s Concerns on NGS Coverage (March 21, 2018)
• CAP Comments on Proposed NCD for NGS for Medicare Beneficiaries with Advanced Cancer (January 17, 2018)
• CAP Participates at White House ‘Cancer Moonshot’ Event to Announce New Initiatives (October 18, 2016)
• Precision Medicine Update: FDA Publishes Guidance Documents on NGS Tests (July 12, 2016)
• CAP Engages with FDA on NGS Oncology Panels, Precision Medicine (April 12, 2016)
• CAP Comments to FDA on NGS-Based Oncology Panels (March 28, 2016)
• CAP Engages with FDA on Standards for NGS (January 19, 2016)
• CAP Comments to FDA on Standards-Based Approach to Analytical Performance of NGS In Vitro Diagnostic Tests (December 24, 2015)