All Of Us Program Begins Returning Genetic Results to Participants - medtigo



All Of Us Program Begins Returning Genetic Results to Participants

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The All of Us Research Program of the National Institutes of Health has begun returning personalized health-related DNA results to more than 155,000 participants, including reports indicating whether participants have an increased risk for specific health conditions and how their bodies may process medications.

This is an important milestone for the program, fulfilling its goal to exchange information and provide participants with value.  

“Knowledge is effective. By returning health-related DNA information to participants, we are changing the research paradigm, turning it into a two-way street – fueling both scientific and personal discovery that could help individuals navigate their own health,” said Josh Denny, M.D., M.S., CEO of the All of Us Research Program.

This type of engagement with our participants is essential for fostering trust and delivering on our promise to conduct research that can bring valuable insights to all. All of Us intends to expedite medical breakthroughs in collaboration with at least one million individuals who reflect the diversity of the United States.

Approximately 80% of All of Us participants are from historically underrepresented communities in medical research, and approximately 50% of All of Us participants identify as members of a racial or ethnic minority group.

In December of 2020, the program began returning genetic ancestry and trait findings to participants. More than 175,000 participants have received genetic ancestry and trait results to date, and the program continues to yield approximately 6,000 results every month.  

In this initial round of returning health-related DNA data, participants who accepted to receive genomic information and gave a blood sample are being personally invited to obtain their results. They may select whatever health-related outcomes they desire if any. Those who opt to obtain their findings will be notified several weeks later when they are ready.

In addition, genetic counselors are available to meet with participants, their family members, or their health care practitioner to evaluate their results and discuss their implications.  

Informed by guidelines from the American College of Medical Genetics and Genomics, the program’s Hereditary Disease Risk report covers 59 genes and variations that are associated with significant, medically actionable health disorders. These genes are associated with an elevated risk of a variety of malignancies, heart problems, and blood diseases.

The initiative expects 2% to 4% of participants to receive a result indicating a pathogenic or potentially pathogenic mutation in one of the genes included in the report.


Those whose findings indicate an elevated risk of a significant health problem will be offered a free clinical DNA test through the program’s genetic counseling facility, which will be administered outside of the program. Color Health, which provides genetic counseling services to All of Us participants, will provide this DNA test.  

Participants may also elect to receive a Medicine and Your DNA report that covers seven genes known to influence how the body processes particular medications.

On the basis of these data, nearly all participants will learn more about how their bodies process pharmaceuticals; nonetheless, participants are urged to visit a health care practitioner and undertake the proper clinical tests before to making any adjustments to their prescriptions.  

“Our volunteers are concerned about both their own health and medical research. This intentional focus can serve as a catalyst for change to increase representation in medical research.  

“Returning information in research projects is the ethical thing to do, but it must be done properly and fairly,” said Alicia Zhou, Ph.D., chief science officer of Color Health, the Genetic Counseling Resource for the All of Us Research Program. All of Us establishes a new standard for longitudinal research initiatives.  

All of Us collaborates with a consortium of national and community partners across the United States to help collect DNA samples and data from surveys, physical measures, electronic health records (EHRs), and wearables. The Data and Research Center, Participant Technology Systems Center, and Genetic Counseling Resource of the program collaborated closely with the program and other partners to design the procedure for returning health-related genetic results.

The Biobank and Genome Centers of the initiative partnered to produce the genomic data that informs the tailored outcomes. Throughout 2023, the initiative intends to increase the number of participants invited to get genetic health-related results, including new participants. 

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