Looking to advance personalized medicine and customize patient care, the FDA is seeking stakeholder input on the challenges and opportunities of next-generation sequencing-based clinical tests to guide its regulatory approach toward these products.
That feedback will help shape discussions during two back-to-back workshops on NGS tests, scheduled for Nov. 12 and 13 at the agency’s White Oak campus in Silver Spring, Md. Both workshops are aimed at advancing the White House’s Personalized Medicine Initiative, which President Barack Obama introduced earlier this year. The goal is to approach disease treatment and prevention with an individual’s genes, environment and lifestyle in mind.
The workshops will build on findings from a February meeting that convened a range of experts on NGS technology.
The first workshop will focus on analytical performance evaluation standards that developers can use to ensure the accuracy and reliability of their tests’ results. According to a Federal Register notice, topics for discussion include an example of a possible performance standard and a general framework that utilizes existing guidelines.
Day two will examine current challenges in the clinical validation of NGS tests and how stakeholders can develop curated databases that associate genetic changes with different conditions and diseases, such as diabetes.
“A single company, lab, or institution is unlikely to have enough information to definitively determine the clinical importance of test results,” say Adam Berger, senior staff fellow on CDRH’s personalized medicine staff, and Zivana Tezak, associate director for science in the Office of In Vitro Diagnostics, in an FDA Voice blog.
“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 FDA plans to post papers ahead of the meetings detailing its thinking on issues slated for discussion.
Interested parties may submit comments on both workshop topics through Nov. 25. Read the Federal Register notices here: www.fdanews.com/FDA-NGS-Day1.pdf and here: www.fdanews.com/FDA-NGS-Day2.pdf. —Elizabeth Hollis