2016 AMP: Integration of Risk Assessment Strategies and Quality Control Plans for Next-Generation Sequencing-based Assays at a Time of Evolving Quality Assurance and Regulatory Frameworks
Next generation sequencing (NGS) is key for the implementation of personalized medicine into diagnostics. Most NGS diagnostics assays are developed as Laboratory Developed Test (LDTs). The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations remains the main regulatory framework for LDT testing. Professional stakeholders and regulatory agencies are actively working on evolving NGS assays Quality Assurance (QA) frameworks and regulatory requirements. As the U.S. Food and Drug Administration (FDA) continues its work on a NGS LDTs Policy, parallel discussions on modernizing CLIA LDT oversight are in progress by additional stakeholders such as the Centers for Medicare & Medicaid Services (CMS), the College American of Pathologist (CAP), the American College of Medical Genetics (ACMG), the American Medical Association (AMA), and the Association for Molecular Pathology (AMP).