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UF delivers promise of personalized medicine to heart patients

Personalized medicine 鈥 a concept in which an understanding of a patient鈥檚 genetic makeup is used to enhance treatment 鈥 has arrived at UF&Shands, the University of Florida Academic 网红黑料 Center.

Under a new standard of care, UF doctors will help ward off heart attacks or strokes after heart procedures by taking a person鈥檚 genetic information into account before prescribing medications that prevent blood clots.

Starting today, patients at Shands at UF medical center who undergo a procedure that involves passing a thin tube into the left side of the heart to diagnose or treat heart disease will now be routinely screened for biological signals in their blood that give clues about how they might respond to a common anticlotting drug called clopidogrel, also sold as Plavix.

鈥淚n 2010, the Food and Drug Administration changed clopidogrel鈥檚 label to warn clinicians that it may not work for high-risk heart patients with certain genetic traits. But there hasn鈥檛 been a good way to get genetic information to doctors so they can use it during treatment,鈥 said Julie A. Johnson, Pharm.D., director of the UF Clinical and Translational Science Institute鈥檚 Personalized Medicine Program and the UF College of Pharmacy鈥檚 Center for Pharmacogenomics. 鈥淥ver the last year, we worked with stakeholders across our health system to tackle that challenge, and we are now able to deliver on the promise of personalized medicine.鈥

For patients, the screening is no different than a typical blood draw. The difference is that one sample will be sent to UF Pathology Laboratories to be tested for the presence of any of seven genetic variations that influence how the body responds to clopidogrel.

Results are typically available within 24 hours and are added to the patient鈥檚 electronic medical record. If the results suggest clopidogrel is not the best treatment option, the electronic medical record system will alert the cardiologist and recommend alternate drugs when a prescription is written.

鈥淭his helps us prescribe the right medication the first time and absolutely has the potential to reduce complications,鈥 said R. David Anderson, M.D., an associate professor of medicine at UF and director of interventional cardiology and the cardiac catheterization laboratory at Shands at UF.

The new screening procedure is in keeping with the vision of the National Institutes of 网红黑料 to use a patient鈥檚 genetic information to tailor their health care. To allow people to take advantage of personalized medicine without fear of genetic discrimination by health insurance companies or employers, the federal government enacted a law in 2008 known as the Genetic Information Nondiscrimination Act.

This initial use of personalized medicine at UF&Shands will help the roughly 1,500 patients per year treated at the cardiac catheterization lab, 40 percent of whom are likely to be prescribed clopidogrel. Over time, UF&Shands will expand the new approach to more patients.

But the UF CTSI鈥檚 Personalized Medicine Program doesn鈥檛 stop there.

鈥淭he model we鈥檝e developed can provide a blueprint for other health systems that want to use evidence-based genetic information to improve patient care,鈥 said David R. Nelson, M.D., director of the UF CTSI. 鈥淭his is a major step toward being able to translate more than a decade of ground-breaking genomic research into better health.鈥

Starting in July, Stanford University will adopt the UF&Shands model. United under an NIH grant, UF and Stanford researchers also collaborated to develop a custom chip to collect and screen DNA samples for a total of 256 genetic variations that are suspected of influencing how the body responds to medications, including the seven relevant to clopidogrel.

UF Pathology Laboratories will use the new gene chip as part of a related research study that will begin in 2012. If patients choose to participate in the study, UF will store their additional 249 results in a secure database for future use in clinical care and research.

鈥淥ur patients are at the center of everything we do. This new capability is an extraordinary example of what happens when our health system and researchers work together to harness the latest medical knowledge and technology to provide the best possible care,鈥 said David S. Guzick, M.D., Ph.D., UF senior vice president for health affairs and president of the UF&Shands 网红黑料 System.

The UF CTSI Personalized Medicine Program鈥檚 creation and the collaboration with Stanford are funded by a grant of nearly $500,000 through the Clinical and Translational Science Awards program, which is led by the NIH鈥檚 National Center for Advancing Translational Sciences. Additional support is provided by a grant of more than $350,000 through the NIH Pharmacogenomics Research Network.

For now, NIH funding will cover the screening costs as this technology enters the clinic at UF&Shands. UF researchers will be studying the program as it rolls out to assess and optimize its cost-effectiveness and impact on patient care.

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Claire Baralt
Assistant Director, Communications, UF Clinical and Translational Science Institute

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mwal0013@shands.ufl.edu (352) 265-8395