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WASHINGTON--The United States has proposed analyzing genetic information from more than 1 million American volunteers as part of a new initiative to understand human disease and develop medicines targeted to an individual's genetic make-up.
At the heart of the "precision medicine" initiative, announced on Friday by President Barack Obama, is the creation of a pool of people - healthy and ill, men and women, old and young - who would be studied to learn how genetic variants affect health and disease. Officials HOPE genetic data from several hundred thousand participants in ongoing genetic studies would be used and other volunteers recruited to reach the 1 million total.
"Precision medicine gives us one of the greatest opportunities for new medical breakthroughs we've ever seen," Obama said, promising that it would "lay a foundation for a new era of life-saving discoveries."
The near-term goal is to create more and better treatments for cancer, Dr. Francis Collins, director of the National Institutes of Health (NIH), told reporters on a conference call on Thursday. Longer term, he said, the project would provide information on how to individualize treatment for a range of diseases.
The initial focus on cancer, he said, reflects the lethality of the disease and the significant advances against cancer that precision medicine has already made, though more work is needed.
The president proposed $215 million in his 2016 budget for the initiative. Of that, $130 million would go to the NIH to fund the research cohort and $70 million to NIH's National Cancer Institute to intensify efforts to identify molecular drivers of cancer and apply that knowledge to drug development.
A further $10 million would go to the Food and Drug Administration to develop databases on which to build an appropriate regulatory structure; $5 million would go to the Office of the National Coordinator for Health Information Technology to develop privacy standards and ensure the secure exchange of data.
The effort may raise alarm bells for privacy rights advocates who have questioned the government's ability to guarantee that DNA information is kept anonymous. Obama promised that "privacy will be built in from day one."
The funding is not nearly enough to sequence 1 million genomes from scratch. Whole-genome sequencing, though plummeting in price, still costs about $1,000 per genome, Collins said, meaning this component alone would cost $1 billion.
Instead, he said, the national cohort would be assembled both from new volunteers interested in "an opportunity to take part in something historic," and existing cohorts that are already linking genomic data to medical outcomes.
The most ambitious of these is the Million Veteran Program, launched in 2011 by the Department of Veterans Affairs. Aimed at making genomic discoveries and bringing personalized medicine to veterans, it has enrolled more than 300,000 veterans and determined DNA sequences of about 200,000. The VA was a pioneer in electronic health records, which it will use to link the genotypes to vets' medical histories.
Academic centers have, with NIH funding, also amassed thousands of genomes and linked them to the risk of disease and other health outcomes. The Electronic Medical Records and Genomics Network, announced by NIH in 2007, aims to combine DNA information on more than 300,000 people and look for connections to diseases as varied as autism, appendicitis, cataracts, diabetes and dementia.
