Monday, June 6, 2022
Cathy Sharkey, Xiaohan Wu, Michael Walsh, and Kenneth Offit have posted to SSRN Regulatory and Medical Aspects of DTC Genetic Testing. The abstract provides:
The recent Food and Drug Administration (FDA) marketing authorizations granted for testing mutations associated with hereditary breast and colon cancer, as well as pharmacogenomic susceptibilities, provide an opportunity to reexamine the medical as well as regulatory underpinnings of direct-to-consumer genetic testing (DTC-GT). In this chapter, we make the case for federal regulation of DTC-GT at two levels: protecting consumers/patients who access particular tests and building an informational environment for genetic testing that supports innovation in the aggregate.