Color's software and services platform for the Return of Personalized Value to the All of Us Research Program participants

ABSTRACT The All of Us Research Program (the Program) aims to accelerate health research and medical breakthroughs by establishing a rich cohort of at least one million participants across the US. To maximize scientific value, the cohort will draw from all parts of the country, and will contain scientifically relevant variation in terms of health conditions, genetics, health care interactions, and health needs. Color Health, Inc. (Color) is an organization that improves health through best-in-class diagnostic genetic testing, scalable clinical services, and user-centered software. Over the past five years, Color has developed a custom return of results platform for the All of Us Research Program, and has provided high-quality clinical services as the Program’s Genetic Counseling Resource (GCR). To date, Color’s software and professional services have made research DNA results available to more than 240,000 All of Us participants nationwide, and has provided more than 3,500 genetic counseling appointments. Here, we outline our proposal to transition to a higher-quality and lower cost approach to providing participant value: specifically, enabling clinical genetic testing for All of Us Research Program participants. We describe our technical approach and capabilities to ensure the success of the Program as it tackles new partner integrations, enrolls new participant cohorts, and launches ancillary studies. Color's technical approach includes scaled services including distributed biospecimen collection, high capacity, clinical genetic testing in our CAP/CLIA high-complexity genetic testing laboratory, expert clinical interpretation, genetic counseling, and participant facing software for registration eligibility checking, appointment scheduling and results delivery. Our experience in software development, regulatory compliance, and participant-centric design ensures high-quality, scalable, and secure services, meeting immediate Program needs and supporting future expansions, including new genomic results and other information types. Finally, Color proposes to support the program through this transition period by being an active part of the consortium and by incorporating input from stakeholders across Program Staff and partners. Through these efforts, Color aims to advance the All of Us Research Program's ultimate goal of driving outcomes: faster, more transparent precision medicine research, to enable better health for all Americans.