![]() But the prospect of applying this concept broadly has been dramatically improved by the recent development of large-scale biologic databases such as the human genome sequence powerful methods for characterizing patients such as proteomics, metabolomics, genomics, diverse cellular assays, and even mobile health technology and computational tools for analyzing large sets of data.” “Blood typing, for instance, has been used to guide blood transfusions for more than a century. “The concept of precision medicine-prevention and treatment strategies that take individual variability into account-is not new,” says NIH Director Francis Collins, PhD. Genomics has been an area of research at the National Institutes of Health (NIH) for years. The President has essentially resuscitated the legislation’s main provisions. ![]() 3 Among other things, that bill would have established a national biobanking distributed database for the collection and integration of genomic data and associated environmental and clinical health information, made information available on the safety and efficacy of genetic tests, and commissioned a study of improvements to federal oversight and regulation of such tests. In 2007, as a senator from Illinois, he introduced the Genomics and Personalized Medicine Act of 2007. President Obama has long been interested in pushing genetic diagnostic testing into a new era. But the tests often lack specificity, in part because they are unable to drill down deep enough into a patient’s genome-because the patient’s genetic code cannot yet be read due to insufficient technology, and because the testing technology that does exist is immature. Most of the genetic diagnostic tests used to determine whether a patient will benefit from a drug such as imatinib have been developed by the company selling that drug. Imatinib precisely targets the cancer cells. There are already “targeted” treatments such as imatinib mesylate (Gleevec, Novartis), available for the past decade, which is highly effective against a form of blood cancer known as chronic myeloid leukemia. Nonetheless, the draft bill, which will be revised on its way to what the committee hopes will be congressional passage by the end of 2015, is supported by both Democrats and Republicans, at least at this early stage. The bill has a number of sections that to some extent parallel the President’s research focus, but many of its provisions go way beyond research-to Medicare payment policy, for example. Diana DeGette (D-Colorado) are the prime movers behind the bill, which they acknowledge is “far from perfect” in draft form. ![]() 2 Committee Chairman Fred Upton (R-Michigan) and Rep. That new funding would be part of the fiscal 2016 budget, which begins on October 1, 2015-but only if Congress approves the money.Īt about the same time, the House Energy and Commerce Committee released a draft of legislation that is a compilation of bills arising from the committee’s series of “21st Century Cures” hearings in 2014. ![]() 1 A proposed $215 million budget increase spread across three agencies backed up the rhetoric. President Barack Obama highlighted the emerging effort when he announced a “Precision Medicine” initiative as part of his 2015 State of the Union speech. Democrats and Republicans in Washington apparently agree on one thing: the need to initiate a vigorous effort to develop genetic tests and targeted, genomic medicines that reach small populations within specific disease groups. ![]()
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