Tuesday, April 22, 2014

FDA Announces Another Workshop on Next-Gen Sequencing - September 24-25, 2014

The FDA has just announced another workshop on policy for next-generation sequencing.  (See the meeting announcement here.)  According to the announcement, two-day event will focus on:

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).