US 'standing at doorstep of discovery' with new PMI announcements

The White House is looking to start enrolling patients in the Precision Medicine Initiative by November--and that’s going to take a lot of work from government and provider organizations.

In a slew of announcements on the project made late Wednesday, one of the biggest is $55 million in awards for fiscal year 2016 from the National Institutes of Health to build infrastructure for the program.

The national research cohort of 1 million people will take about three to four years to assemble, NIH Director Francis Collins said during a press call on the announcement.

Bringing together doctors and data is “one of the greatest opportunities we’ve ever seen for new medical breakthroughs, but it only works if we collect enough information first,” President Barack Obama, who announced the PMI during his 2015 State of the Union Address, wrote in an op-ed at the Boston Globe.

“[W]e’re working to ensure more people will also have access to the information that makes their healthcare more effective. It won’t happen overnight, but we’re standing once again at the doorstep of discovery,” he wrote.

NIH’s Collins added during the call that a big goal is setting the cohort up so it empowers “anyone in the United States to be able to raise their hand and volunteer to participate.

“That means people from all walks of life. Rich and poor, young and old, urban and rural, and all races and ethnicities. This is about all of us,” he said.

The $55 million in NIH awards will go toward:

  • A network of healthcare provider organizations operated by the Veterans Affairs Department to get vets enrolled in the program. It includes four initial participants: Columbia University Health Sciences, New York City; Northwestern University, Chicago; University of Arizona, Tucson; and the University of Pittsburgh. More will be added in the coming months, Collins said. 
  • A pilot through the Health Resources Services Administration to determine infrastructure needs at community health centers to enroll patients. Six centers have been chosen.
  • A Data and Research Support Center, awarded to Vanderbilt University Medical Center, in Tennessee, the Broad Institute in Massachusetts and Verily Life in California. It will “acquire, organize and provide secure access to what will be one of the world’s largest and most diverse datasets for precision medicine research,” according to NIH.
  • A Participant Technologies Center, which through the work of Scripps Research Institute and Vibrent Health in Fairfax, Virginia, will create ways for participants to enroll in the program via computer, smartphone or call center.

Meanwhile, the U.S. Food and Drug Administration's role, Commissioner Robert Califf said during the call, will be focused on genomic testing and, specifically, next generation sequencing (NGS).

Two new guidances have been released by the FDA on NGS to “provide the basis for a flexible and streamline approach to the oversight of NGS-based tests,” Califf said.

The first will address how accurately a test is able to ID a genetic variant. The second describes an approach for using evidence from publicly-accessible, FDA-recognized genetic databases to determine that the test is clinically valid in predicting a disease or condition, according to Califf.

“Precision medicine gives us the chance to marry what’s unique about America--our spirit of innovation, our courage to take risks, our collaborative instincts--with what’s unique about Americans,” Obama wrote in his op-ed. “In doing so, we can keep ourselves, our families and our nation healthier for generations to come.”

To learn more:
- here's the NIH announcement
- check out the FDA's guidances  
- read President Obama's op-ed
- here's a White House fact sheet