Establishing protocols for ensuring the safety and quality of next-generation sequencing (NGS)-related information without sacrificing scientific merit or interfering with innovative processes.The purpose of the workshop is to engage NGS stakeholders in a forum to discuss the current use of the technology and the development of data standards of NGS-related information.
This is the third or fourth FDA event on Next Generation Sequencing. The FDA held a one-day discusssion on June 23, 2011 (see the agenda and powerpoint presentations here and an official meeting summary here). In early 2014, the FDA also held a meeting on NGS for micriobiology (here). And there was a considerable flurry in the press when the FDA began approving NGS platforms later in 2014 (typical press here and here, and a joint NIH/FDA article in the New England Journal of Medicine here.)
Last January, the Center for Medical Technology Policy in Baltimore announced the launch of a year-long effort to study guidelines for NGS clinical utility evidence (press release here; news at the proprietary website Genomeweb, here). The "paradigm shift" for integrating NGS into clinical testing in oncology was also a topic this month at the American Associatoin for Cancer Research (AACR) meeting in San Diego (also from Genomeweb, here).
