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AMP Weighs In on Regulation of Next-Generation Sequencing

By Stephanie Murg, Managing Director, G2 Intelligence As the U.S. Food and Drug Administration (FDA) evaluates its role in regulating next-generation sequencing (NGS)-based diagnostic tests, a range of stakeholders have responded to the agency’s request for feedback in the wake of its February 20 public workshop on the topic. Among the notable submissions are written comments submitted recently by the Association for Molecular Pathology (AMP; Bethesda, Md.). The non-profit organization urged FDA to focus on helping to ensure the performance characteristics of NGS instruments, reagents, and related software. AMP also recommended that FDA partner with private sector organizations and experts to set standards for FDA-cleared or approved instruments, test kits, and software. “While we see the value for FDA to help ensure performance consistency of NGS diagnostic tests, we stand firm that the assay design, validation, and interpretation of NGS procedures are essential medical services performed by highly qualified professionals, and that these central practices of medicine must remain outside the purview of FDA,” said AMP NGS Working Group Chair Andrea Ferreira‐Gonzalez, Ph.D., Chair of the Division of Molecular Diagnostics in the Department of Pathology at the Virginia Commonwealth University Health System. Directly addressing several points highlighted in the FDA’s […]

By Stephanie Murg, Managing Director, G2 Intelligence

As the U.S. Food and Drug Administration (FDA) evaluates its role in regulating next-generation sequencing (NGS)-based diagnostic tests, a range of stakeholders have responded to the agency’s request for feedback in the wake of its February 20 public workshop on the topic. Among the notable submissions are written comments submitted recently by the Association for Molecular Pathology (AMP; Bethesda, Md.). The non-profit organization urged FDA to focus on helping to ensure the performance characteristics of NGS instruments, reagents, and related software. AMP also recommended that FDA partner with private sector organizations and experts to set standards for FDA-cleared or approved instruments, test kits, and software.

“While we see the value for FDA to help ensure performance consistency of NGS diagnostic tests, we stand firm that the assay design, validation, and interpretation of NGS procedures are essential medical services performed by highly qualified professionals, and that these central practices of medicine must remain outside the purview of FDA,” said AMP NGS Working Group Chair Andrea Ferreira‐Gonzalez, Ph.D., Chair of the Division of Molecular Diagnostics in the Department of Pathology at the Virginia Commonwealth University Health System.

Directly addressing several points highlighted in the FDA’s preliminary discussion paper as requiring further study, the AMP’s NGS Working Group has emphasized its view that new regulatory initiatives should utilize an approach that is flexible enough to accommodate the ongoing technological developments and exponentially increasing body of medical and scientific knowledge that characterizes NGS-based diagnostic tests in a timely manner. Adds Roger D. Klein, M.D., J.D., Chair of AMP’s Professional Relations Committee, “It is critical that FDA recognize the promise these new technologies hold for patients and health care providers, and refrain from taking actions that could impair this progress.”