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White House proposes accelerated development for gene mutations testing

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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.

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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.

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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.

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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.”

(Reporting by Toni Clarke; Editing by Matthew Lewis)

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Enjoy this piece?

… then let us make a small request. Like you, we here at Raw Story believe in the power of progressive journalism — and we’re investing in investigative reporting as other publications give it the ax. Raw Story readers power David Cay Johnston’s DCReport, which we've expanded to keep watch in Washington. We’ve exposed billionaire tax evasion and uncovered White House efforts to poison our water. We’ve revealed financial scams that prey on veterans, and efforts to harm workers exploited by abusive bosses. We’ve launched a weekly podcast, “We’ve Got Issues,” focused on issues, not tweets. Unlike other news sites, we’ve decided to make our original content free. But we need your support to do what we do.

Raw Story is independent. You won’t find mainstream media bias here. We’re not part of a conglomerate, or a project of venture capital bros. From unflinching coverage of racism, to revealing efforts to erode our rights, Raw Story will continue to expose hypocrisy and harm. Unhinged from corporate overlords, we fight to ensure no one is forgotten.

We need your support to keep producing quality journalism and deepen our investigative reporting. Every reader contribution, whatever the amount, makes a tremendous difference. Invest with us in the future. Make a one-time contribution to Raw Story Investigates, or click here to become a subscriber. Thank you.



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‘Mental midget’ Stephen Miller absolutely demolished in MSNBC blast at Trump’s ‘misfit’ advisers

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Given the opportunity to discuss two profiles on White House adviser Stephen Miller -- published by the Washington Post and the New York Times late Saturday -- Democratic consultant Don Calloway jumped in with both feet to trash the man he called a "mental midget"."

Asked p on MSNBC about the controversial Miller's outsized influence on Donald Trump, Calloway didn't hold back.

"What goes through your head when you hear how much influence Stephen Miller has on immigration policy?" host Alex Witt asked.

"Stephen Miller is a mental midget, that's the best thing I can say," Calloway began to the sounds of laughter offscreen.

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Black woman reveals how Trump is ruining her marriage: ‘My white Republican husband is starting to hate me’

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A black woman revealed over the weekend how President Donald Trump and right-wing media are straining her marriage.

In a Twitter rant on Saturday, a woman going by the name Glass Butterfly hit a nerve by starting a discussion about the challenges of interracial marriage in the age of Trump.

"My white Republican husband is starting to hate me because the longer we live through this administration the 'BLACKER' I become," she revealed. "Any interracially and opposing politically affiliated couples going through this? Like...I have NO idea how to balance who we are..or are becoming."

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Lawmaker Rashida Tlaib calls for boycott of Bill Maher’s ‘Real Time’ over Israel comments

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Rep. Rashida Tlaib, D-Mich., suggested a boycott against HBO host Bill Maher after he denounced the international movement to boycott Israel as a "bullshit purity test by people who want to appear woke but actually slept through history class."

This article first appeared on Salon.

"Maybe folks should boycott his show," Tlaib wrote in a tweet on Saturday. "I am tired of folks discrediting a form of speech that is centered on equality and freedom. This is exactly how they tried to discredit & stop the boycott to stand up against the apartheid in S. Africa. It didn't work then and it won't now."

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