CDRH has scheduled two next generation sequencing (NGS) workshops on November 12 and 13, 2015 (see here and here for the Federal Register announcements) to further advance the conversation with stakeholders on the Agency’s development of new regulatory strategies for NGS-based clinical tests.  These workshops will build upon a discussion paper published in December 2014, which we summarized in a previous blog post, and a public workshop with stakeholders held earlier this year.

As we discussed in our previous blog post, NGS refers to technologies that can perform sequencing of large segments of an individual’s DNA, and even the individual’s entire genome.  NGS tests pose regulatory challenges to FDA, because they can “generate large amounts of data and consequently may have relatively broad or undefined intended uses or indications.”  79 Fed. Reg. 78092, 78093 (Dec. 29, 2014).  The agency states in a blog post that FDA seeks “to ensure that these tests provide accurate, reproducible, and meaningful results relevant to a person’s medical condition while continuing to foster innovation so that people have access to the best available results generated by the most cutting-edge medical technologies.”

The first of the two workshops held in November will focus on obtaining feedback on “possible analytical standards and approaches to develop or build on existing standardization efforts in order to optimize FDA’s regulatory approach to NGS-based in vitro diagnostic tests.”  The second workshop will address current challenges in clinical validation of NGS tests.  According to FDA’s blog post, the workshop will discuss 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.”

FDA plans to publish additional discussion papers in advance of these two workshops.  These papers will include general questions for stakeholder consideration and also provide a “high level overview” of regulatory considerations for the two issues to be covered by the workshops.  We will provide updates when the two papers are published.