AMP Looks Forward to Working with FDA on Guidance for Next-Generation Sequencing-Based Tests
Organization’s NGS Working Group will submit formal comments
to two new draft guidances designed to advance Precision Medicine Initiative
Bethesda, MD - July 7, 2016 - 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 AMP plans on submitting formal comments to the two new draft guidance documents, "Use of Standards in FDA’s Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline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.
The Association for Molecular Pathology (AMP) was founded in 1995 to provide structure and leadership to the emerging field of molecular diagnostics. AMP's 2,300+ members practice in the various disciplines of molecular diagnostics, including infectious diseases, inherited conditions and oncology. They include individuals from academic and community medical centers, government, and industry; including pathologist and doctoral scientist laboratory directors; basic and translational scientists; technologists; and trainees. Through the efforts of its Board of Directors, Committees, Working Groups, and members, AMP is the primary resource for expertise, education, and collaboration in one of the fastest growing fields in healthcare. AMP members influence policy and regulation on the national and international levels, ultimately serving to advance innovation in the field and protect patient access to high quality, appropriate testing. For more information, visit www.amp.org.