The Association for Molecular Pathology (AMP), the premier global, non-profit organization serving molecular diagnostic professionals, today announced that it looks forward to working with the U.S. Food and Drug Administration (FDA) to determine the best adaptive approach to regulating Next-Generation Sequencing (NGS) tests. AMP plans on submitting formal comments to the two new draft guidance documents, "Use of Standards in FDA's Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases" and "Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics, which were issued on July 6, 2016 as part of President Obama's Precision Medicine Initiative.
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