WASHINGTON – The White House announced on Wednesday measures aimed at advancing President Barack Obama's precision medicine initiative, including plans to speed the development of tests used to identify genetic mutations and guide medical treatment.
The U.S. Food and Drug Administration said it planned to issue a proposal on Wednesday to create performance standards to guide development of next generation sequencing (NGS) tests. These tests scan a person's DNA and identify genetic differences that could be responsible for a patient's symptoms.
The standards would be designed to assess how accurately a test identifies a genetic variant. The developer would certify that it had met those standards. Currently the FDA itself determines the test's accuracy.
"We believe that the use of standards is the best way to allow regulation to keep pace with the evolution of NGS technology," Dr. Robert Califf told reporters on a conference call.
A second FDA proposal would allow test developers to use data from publicly accessible genetic databases, not just their own data, to demonstrate that the test accurately predicts disease. Califf said the approach could potentially get rid of the need for the FDA to review the tests before they reach the market.
"Taken together, these guidances will foster innovation, assure the quality and reliability of NGS-based tests and promote their adoption into clinical practice," he said.
The FDA's action is part of a broader government initiative to promote the development of individually tailored medicines. Obama introduced the initiative in his State of the Union address last year, saying he wanted the United States to lead a new era of medicine, "one that delivers the right treatment at the right time."
As part of the project, the National Institutes of Health will invest $55 million to build the infrastructure needed to collect genetic data from more than 1 million volunteers, its director, Dr. Francis Collins, said on the conference call.
Collins said it will take three to four years to assemble the desired amount of genetic material, which will then be available to researchers to help develop drugs for cancer and other disease. Anyone, he said, can participate.
"This is about all of us," he said. "Participants will be true partners, not subjects, not patients." Data sharing, he added, will be "swift."