President Barack Obama used some of his State of the Union oratory to lay out a grand vision for “precision medicine” and announce an initiative to realize it.
“I want the country that eliminated polio and mapped the human genome to lead a new era of medicine—one that delivers the right treatment at the right time,” he said. The initiative would help to “give all of us access to the personalized information we need to keep ourselves and our families healthier.”
According to a White House document accompanying the speech, the initiative would involve increased investment, though it's unclear what agencies the money would be channeled through.
“Precision medicine” typically refers to the use of genomics to tailor treatments to the individual based on an analysis of one's DNA. Indeed, Obama referred in the speech to Kalydeco, a cystic fibrosis drug from Vertex Pharmaceuticals, which helps treat the root causes of the disease in a subset of patients with a specific genetic mutation.
The term, however, can be broader than that. Dr. Jeff Shuren, director of the Food and Drug Administration's Center for Devices and Radiological Health, pointed out in a July 2014 roundtable discussion on precision medicine that many device manufacturers hope to unveil devices that are tailored to a patient's physiology, such as 3-D printed implants that conform to a patient's body.
The White House has revealed few details on the initiative. HHS Secretary Sylvia Mathews Burwell said in a Jan. 15 speech to the New America Foundation that she hoped to “work with the Congress to scale up the initial successes we have seen in this promising avenue of scientific endeavor.” Obama's speech, however, did not suggest that the administration planned to pursue the initiative through legislation. The White House's media team had not responded to queries at deadline.
Precision medicine has been part of the focus of the House Energy & Commerce Committee's ongoing 21st Century Cures initiative, which is expected to yield a broad legislative package that will propose regulation changes and promote investments in healthcare delivery and technologies. Energy & Commerce Chairman Rep. Fred Upton (R-Mich.) said in a statement before the State of the Union that he hoped the president would be able to work with him on delivering 21st Century Cures.
Lynn Etheredge, director of the Rapid Learning Project, an effort to use big data and electronic health records to assess the effectiveness of medical treatments, said that he's very hopeful about precision medicine's impact. “Mostly our science has been built around testing response to average patients. In fact we know that for most of our chronic diseases, there's a wide range of response to the same treatment,” he said. More research will allow clinicians to make more-precise diagnoses, which will in turn drive better treatments.
Delivering on precision medicine's promise is the culmination of many previous technological and policy efforts, noted Colin Hill, co-founder and CEO of GNS Healthcare, a company specializing in precision analytics.
Delivering the right treatment at the right time, he said, requires cheap sequencing technology and actual patient outcomes data, delivered through an EHR. That allows researchers and clinicians to more closely observe the real-world effect of their precision-guided treatments.
Hill said it's “about time” for the government to push precision medicine. But there is a risk, he said. “Money does a lot of things” in spurring research and development, he said. But genomics data needs to be married to real-world impact data. “There's more data-sharing that needs to happen,” he said, though he added that he's encouraged by recent progress in that area.
Dr. David Shaywitz, the chief medical officer of cloud-based genomic analysis startup DNAnexus, agreed with some of Hill's caution. “A lot can be accomplished by extensive sequencing if paired with rich phenotyping (outcomes data),” he said. Success in that area, however, means more robust data-sharing—and he hopes that that will be accomplished through the cloud.
The news proved to be a financial buoy to some firms in the genetics space. Illumina, the top manufacturer of genome sequencers, saw a leap in its stock price. Its shares closed at roughly $183 on Jan. 16 and leapt 7% to a high of $196 on Jan. 20 as the White House revealed that the initiative was part of the president's speech. The stock has given back some of its gains, however, falling to roughly $190 Wednesday afternoon.
Follow Darius Tahir on Twitter: @dariustahir