NIH funds genetic counseling for PMI cohort participants

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Genetic counseling will be provided to participants in the National Institutes of Health’s All of Us research program who may get actionable results under the Precision Medicine Initiative.

NIH has awarded $4.6 million in initial funding—part of a multi-year $25 million project—to health technology vendor Color to establish the program’s nationwide genetic counseling and technological infrastructure.

“The All of Us research program is a prime example of using technology to support geographically distributed and diverse research volunteers,” said Color CEO Othman Laraki. “This ambitious program relies on a deeply unified process, which includes engaging participants, gathering health information, sequencing genomes, interpreting data and securely and responsibly returning results.”

According to Laraki, Color will “provide the technological backbone—software and services including our genetic counseling program—to extend the reach of this groundbreaking effort across all 50 states and showcase a scalable model for the integration of genomics into public health.”

“A genetic counseling award of this size is a first for NIH,” said Brad Ozenberger, genomics program director of the All of Us research program. “We look forward to working with Color and our entire consortium to discover ethical and effective ways to deliver genetic counseling at this very large scale across diverse communities.”

The All of Us program intends to sequence the genomes of one million Americans. As of last month, the program has recruited about 250,000 volunteers.

The plan is to make research results from the program accessible to participants and protocols are currently being developed for the return of genetic, laboratory-assay, as well as electronic health record data.

“We are prioritizing the return of information regarding two classes of health-related, actionable genetic variants to participants who have elected to receive such results,” stated the leaders of the All of Us program in a NEJM article published last week.

“Pharmacogenomic results will be returned according to the guidance of the Clinical Pharmacogenetics Implementation Consortium,” according to the authors. “In addition, participants will be informed if they have highly penetrant genetic variants known to cause serious diseases for which there are established interventions; this reporting will be consistent with the recommendations of the American College of Medical Genetics and Genomics for reporting of incidental findings related to 59 genes.”

The All of Us program anticipates that about 30,000 participants will receive actionable findings for American College of Medical Genetics and Genomics genes, and that more than 90 percent may learn of actionable pharmacogenomic variants.

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