Need Better Regulation for Next Gen Sequencing Tests, AMP Urges the FDA

The Association for Molecular Pathology has provided comments to the FDA, urging increased regulation of next generation sequencing diagnostic tests to ensure consistent and proper performance of the tests.

The Association for Molecular Pathology (AMP), the premier global, non‐profit organization serving molecular diagnostic professionals, submitted written comments on March 20 to the FDA in response to the agency’s request for feedback in association with its February 20, 2015 public workshop entitled, “Optimizing FDA's Regulatory Oversight of Next Generation Sequencing Diagnostic Tests.” In its comments, AMP urged FDA to focus its attention on helping to ensure the performance characteristics of next generation sequencing (NGS) instruments, reagents, and related software. AMP further recommended that FDA partner with private sector organizations and experts to set standards for FDA‐cleared or approved instruments, test kits, and software.

Link to the complete press release:

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