The Regulatory Landscape for Clinical NGS: Where Are We and Where Should We Be Going?
Gail H. Javitt, Member of the Firm, will present "The Regulatory Landscape for Clinical NGS: Where Are We and Where Should We Be Going?" at the Cambridge Healthtech Institute’s Next Generation Dx Summit.
Clinical integration of NGS is quickly becoming a reality, but without a clear roadmap, or consensus on how best to achieve it. Thus far, federal regulatory bodies have played a limited role in regulating NGS-based assays, while the private sector has been experimenting with a variety of business models to facilitate the provision of NGS services. This session will describe various approaches to clinical integration of NGS assays currently being used, identify key challenges facing clinical laboratories, physicians and patients, and discuss the current and potential future roles of FDA and CMS in facilitating the delivery of clinically valid and useful NGS-based assays to patients.