A National Institutes of Health effort to establish a cohort of at least 1 million volunteers to boost understanding of diseases could be imperiled if Congress passes a continuing resolution to keep the government running into the new fiscal year.

 House and Senate appropriators included a $200 million request by President Barack Obama to advance precision medicine in their fiscal 2016 Labor-HHS-Education spending measures, $130 million of which would go toward building the national research cohort.

 A House-passed biomedical innovation bill (HR 6) also addresses the use of diagnostic tests to identify biologic markers in individuals that may better identify which medical treatments work best. The Senate is in the process of drafting its own legislation that could also touch on the issue.

Kathy Hudson, deputy director for science, outreach and policy at NIH, said that her agency briefed Obama last week on their precision medicine efforts and will have a more detailed plan that outlines the logistics of assembling the cohort by the middle of next month.

 “Volunteers would provide their health information, genetic information and biological specimens that would be widely available to researchers in order to explore the molecular underpinnings for health and disease and use that information to develop new approaches and treatments,” Hudson said at a Capitol Hill briefing Thursday. “Presuming that we put together a compelling plan for this cohort, [NIH Director] Francis Collins will adopt that and we will be off to the races in the beginning of the fiscal year.”

 But Hudson acknowledged plans could change if lawmakers end up passing a continuing resolution starting Oct. 1. A CR could extend fiscal 2015 enacted funding levels anywhere from a couple days or weeks to longer.

 “We hope that we are in a time of regular order, but in the event that doesn’t happen, we can go ahead and put out funding opportunity announcements to the community, people can be developing their ideas and applications and bring those back to us. We can do merit review," Hudson said. “And by that time, we hope we have an appropriation.” 

Precision medicine is an emerging field, which advocates say can spare patients from expensive, painful and unnecessary treatments. The Food and Drug Administration approved nine targeted therapies last year, its greatest number yet. Personalized medicine can not only help treat diseases, but also has the potential to identify individuals who are at risk for certain diseases.

 “Precision medicine got a lift from the president talking about it in the State of the Union, but we need to continue on that,” said Sen. Amy Klobuchar, D-Minn., at the briefing. “We need to increase the money we invest in research.”

 Although Obama and Congress have expressed interest in addressing personalized medicine, research advocates on Thursday said challenges remain, which they hope will be addressed in the Senate version of the medical innovation bill.

 Barriers include difficulty in delivering precision medicine services across state lines to areas that don’t have such tools available, regulatory hurdles in using a drug approved for one disease on a different indication and insurance limitations in the coverage of diagnostic testing.


“There’s a very small number of people that can afford these tests, and many cannot access these life saving technologies,” said Keith Stewart, director of Mayo Clinic‘s center for individualized medicine.