WASHINGTON, Jan 30 (Reuters) – 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.”
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Collins conceded that mingling the databases would be a challenge but insisted it is doable.
“It is something that can be achieved but obviously there is a lot that needs to be done,” he said.
Collating, analyzing and applying the data to develop drugs will require changes to how products are reviewed and approved by health regulators.
Dr. Margaret Hamburg, the FDA’s commissioner, said precision medicine “presents a set of new issues for us at FDA.” The agency is discussing new ways to approach the review process for personalized medicines and tests, she added. (Reporting by Toni Clarke in Washington; Editing by Cynthia Osterman and Leslie Adler)
