FDA to Build New Regulatory Framework for Genomic Tests

What makes next-generation sequencing-based diagnostic tests alluring also makes them complicated to regulate, but changes to the regulatory framework could ease the adoption of such tests, the Broad Institute’s Eric Lander wrote in a Perspective article in the New England Journal of Medicine this week. Lander said that it would take time to build the necessary regulatory framework at the FDA to deal with NGS-based tests, but he noted that the agency had “already taken small, but significant steps” when it approved Illumina’s MiSeqDx sequencing platform, two associated assays, and a library prep kit in 2013. In its preliminary discussion paper, the FDA asked the community for feedback and will hold a public workshop to discuss these potential new regulatory approaches for next-generation sequencing-based tests.

Source: https://www.genomeweb.com/regulatory-news/nejm-lander-lauds-steps-fda-build-new-regulatory-framework-genomic-tests?utm_source=SilverpopMailing&utm_medium=email&utm_campaign=Daily%20News%3A%20In%20NEJM%2C%20Lander%20Lauds%20Steps%20at%20FDA%20to%20Build%20New%20Regulatory%20Framework%20for%20Genomic%20Tests%20-%2002/18/2015%2011%3A05%3A00%20AM