White House proposes measures to speed
genomic test development
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[July 07, 2016]
By Toni Clarke
WASHINGTON (Reuters) - 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
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
"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."
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A DNA double helix is seen in an undated artist's illustration
released by the National Human Genome Research Institute to Reuters
on May 15, 2012. REUTERS/National Human Genome Research
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
(Editing by Matthew Lewis)
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