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Sept. 8 — The FDA will hold two workshops to get stakeholder input about next-generation sequencing (NGS) and how it can help advance precision medicine, two agency officials said Sept. 8 in an FDA Voice blog post.
The workshops will focus on analytical performance evaluation of NGS diagnostic tests and challenges in clinical validation of these tests.
The FDA wrote that the workshops are part of President Obama’s Precision Medicine Initiative, which envisions a day when the genetic, environmental and lifestyle differences between people will be used to customize the health care they receive.
Many efforts toward achieving this goal, including NGS, have focused on analyzing and interpreting a person’s unique genetic makeup, including the identification of genetic alterations that may affect his or her health, the FDA said.
The article, “FDA Taking Genomic Testing to the Next Level,” was written by Adam C. Berger, senior staff fellow on the personalized medicine staff at the Center for Devices and Radiological Health's Office of In Vitro Diagnostics and Radiological Health, and Zivana Tezak, the CDRH's associate director for science and technology.
NGS refers to the sequencing of millions of small fragments of DNA at the same time, creating a massive pool of data that can be used for medical diagnostics. Berger and Tezak wrote that the FDA is developing regulatory strategies for NGS-based clinical tests to ensure that these tests provide accurate, reproducible and meaningful results relevant to someone’s medical condition while continuing to foster innovation.
The first of the workshops, titled “Standards-Based Approach to Analytical Performance Evaluation of Next Generation Sequencing In Vitro Diagnostic Tests,” will be held Nov. 12 at the FDA White Oak campus in Silver Spring, Md.
It will focus on analytical performance evaluation standards, including potential ways to develop them, which can be used by test developers to ensure that their tests produce accurate and reliable results.
The second workshop, titled “Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants,” will be held Nov. 13 at the same location.
“A single company, lab, or institution is unlikely to have enough information to definitively determine the clinical importance of test results,” Berger and Tezak wrote. “The aggregation of clinical information in curated databases will create a 'data commons' that could serve as a reliable source of scientific evidence that test developers could use to demonstrate that NGS test results are relevant to a person’s disease or outcome.”
The workshop will highlight how scientists, patient groups and private industry can work together to develop high-quality, curated clinical databases of genomic information that associate specific genetic changes with various diseases, such as cardiovascular disease or diabetes.
In advance of these workshops, the authors wrote, the FDA will release additional discussion papers informed by public input, which also will include some general questions for stakeholder consideration.
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