Competition in human genetic technologies: The current US legal landscape

Competition plays a crucial role in driving innovation in the industry of human genetics and genomics technologies. However, the US's policy on competition (such as enforcement of antitrust laws) has shifted over time, affecting the level of regulatory scrutiny that business decisions in the industry will receive. Here, we offer an overview of this changing legal landscape, noting key policy changes at the Federal Trade Commission (FTC) and Department of Justice (DOJ) relevant to the human genetics and genomics industry. Focusing on the regulatory challenge of Illumina's acquisition of Grail as a case study, we highlight how shifting anti-competition enforcement policy could affect spin-offs, startups, and industry consolidations. Balancing competition and consumer protection policies remains essential for the continued advancement of human genetic and genomic technologies. We offer this perspective in the hopes that it will help inform scientists in the field of the relevant legal considerations and stimulate discussions to shape policy-public and private alike-in ways that promote responsible innovation in genetic and genomic science and technology.