Friday, January 9, 2015
Evans and co-author Michael S. Watson, PhD, executive director of the American College of Medical Genetics, suggest that the FDA’s current plan for regulation is unnecessary and could inadvertently stifle the development of genomic medicine.
The substantial expansion in genetic testing and advances in sequencing technology have improved individualized diagnosis and treatment for cancer. Evans and Watson argue that the FDA’s proposal to regulate laboratory-developed genetic tests as “medical devices” would unnecessarily burden the current nimble and competitive landscape of genetic testing laboratories at the expense of innovation.
Read the commentary, Overregulation Threatens the Emergence of Genomic Medicine, which was published online January 5, 2015.