FDA Holding More Workshops Focused on Genetic Testing and NGS Technology

Last year the FDA held workshops to discuss analytical standards for next-generation sequencing (NGS) and use of curated databases for establishing clinical relevance of genetic variants. The FDA continues its engagement with stakeholders regarding NGS technology, this year fostering public discussion regarding patient and provider perspectives about what to do with genetic test results.  Recognizing the vast amount of information that can be yielded from NGS, the difficulty in interpreting results, and lack of evidence in some cases linking genetic variants to specific diseases, the FDA March 2 workshop will discuss how best to make use of the results of genetic testing—based on patient and provider preferences. The goal, the notice of the workshop announced, is “to learn, when results are generated in a CLIA-compliant laboratory, which results are of importance to patients and providers, how these results should be returned and how much and what types of evidence supporting interpretation of those results is necessary.” Registration is free for the workshop but advance registration for in person attendance is recommended. Live streaming webcast is offered for the workshop.