Michael Manganelli Associate Editor Loyola University Chicago School of Law, JD 2021 In October 2019, The Department of Justice (“DOJ”) announced a multi-agency and multi-state coordinated law enforcement action against 35 individuals involved in an alleged $2.1 billion genetic cancer testing scheme. The alleged scheme involved the payment of illegal kickbacks and bribes to medical professionals …
Direct-to-consumer genetic testing kits have exploded in popularity over the last decade. Ancestry.com and 23andMe proudly state they have had ten million and five million customers, respectively, using their DNA testing services. One study projects that improvements in technology and popularity will cause DNA testing to increase tenfold by 2021. Many experts in the field of genetics and bioethics have expressed concern regarding the ability of regulators and privacy infrastructure to keep pace with the expansion of these types of genetic services. We may not be at a point where we understand the full implications of having such large banks of genetic information, but here are five reasons to be concerned.
In recent years, the FDA has examined a record number of revolutionary medical devices, many of which have been genetic tests. Genetics has taken the world by storm. The medical world continues to look toward genetics as a promising next step in revolutionizing treatment, while the American public has shown a growing interest in learning more about themselves through services like Ancestry and 23andMe. In an effort to gain a foothold on the rapidly developing field of technology, the FDA has recently made efforts to modernize its approach by issuing new guidance to ensure the validity of these tests.