AMP looks forward to working with FDA to determine optimal approach to regulating NGS tests

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 AMP plans on submitting formal comments to the two new draft guidance documents, "Use of Standards in FDA's Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline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.

"AMP believes that FDA can best contribute to patient care and public health by helping to assure the analytical validity of NGS instruments, software, and analyte-specific reagents sold to customer laboratories," said Charles Hill, MD, PhD, President of AMP. "We look forward to continuing to work together with the FDA and other experts in the genomics community to determine the most optimal approach that utilizes both design concept and performance standards in order to accommodate rapid technological developments and exponentially increasing medical and scientific knowledge in a timely manner."

AMP will analyze these drafts guidances thoroughly and will continue to engage FDA in discussion, particularly regarding several AMP guidelines and recommendations on NGS validation. The AMP NGS Working Group, which has formulated AMP's position statements and presentations while FDA was contemplating these draft guidances, will prepare AMP's formal comments prior to the 90-day comment period deadline.