Pathologists are helping care team interpret genetic laboratory test results for patients in the cardiac catheterization laboratory
Genetic tests will be part of the regular care protocols for some cardiology patients at both the University of Florida (UF) Clinical and Translational Science Institute (CTSI) and Stanford University Medical Center. Among other factors, it is faster time-to-answer and the lower cost of certain genetic technologies that make it feasible to use genetic tests in this care setting.
In particular, the genetic tests will be used to guide cardiologists as they make therapeutic decisions. Assisting in the interpretation of these tests will be pathologists and clinical laboratory professionals.
According to a CTSI news release, over the summer, UF&Shands launched a new care protocol in its cardiac catheterization laboratory. Cath lab physicians will now routinely review a cardiac catheterization patient’s genetic information before prescribing medications.
The physicians will test the patients for seven genetic variations that signal how a patient might respond to the anti-platelet drug clopidogrel. Clopidogrel is commonly sold under the trade name Plavix.
Scientists suspect that a total of 256 genetic variations influence how the body responds to medications. Seven of those variations are relevant to clopidogrel.
“In 2010, the Food and Drug Administration changed clopidogrel’s label to warn clinicians that it may not work for high-risk heart patients with certain genetic traits,” stated Julie A. Johnson, Pharm.D., F.C.C.P., B.C.P.S, Director of the UF CTSI Personalized Medicine Program and the UF College of Pharmacy’s Center for Pharmacogenomics.”[T]here hasn’t been a good way to get genetic information to doctors so they can use it during treatment.”
The UF CTSI created the Personalized Medicine Program in June 2011, according to the program’s website. Johnson led a multidisciplinary team to develop the necessary infrastructure to generate electronic medical record (EMR) alerts based on genetic testing. Additionally, the team developed a process by which the health system can determine when sufficient evidence exists for pharmacogenetic findings to be considered clinically actionable.
New Personalized Medicine Practice Model
With the new procedure, the UF&Shands cath lab sends a sample of the patient’s blood to UF Pathology Laboratories (UFPL) for genetic testing. UFPL tests the sample for the presence of any of seven genetic variations that influence the body’s response to clopidogrel. Test results, usually available within 24 hours, are added to the EMR.
Thanks to the efforts of Johnson’s team, the EMR system then alerts the cardiologist if clopidogrel is contraindicated. Based on an algorithm that looks at lab test results and the first prescription, the EMR guides the doctor to the right therapeutic drugs.
“[The model] helps us prescribe the right medication the first time and absolutely has the potential to reduce complications,” declared R. David Anderson, M.D., Associate Professor of Medicine at UF and Director of Interventional Cardiology and the Cardiac Catheterization Laboratory at Shands at UF.
UF&Shands treats about 1,500 patients annually at its cardiac catheterization lab. Clinicians will likely prescribe clopidogrel to 40% of them. “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,” said David S. Guzick, M.D., Ph.D., UF Senior Vice President for Health Affairs and President of the UF&Shands Health System.
Stanford Adopts Same Model for Genetic Testing
The CTSI news release noted that the new UF screening procedure aligns with the National Institutes of Health (NIH) goal of using a patient’s genetic information to customize health care decisions.
“The model we’ve developed can provide a blueprint for other health systems that want to use evidence-based genetic information to improve patient care,” observed David R. Nelson, M.D., Director of the UF CTSI. “This is a major step toward being able to translate more than a decade of ground-breaking genomic research into better health.”
One such health system is Stanford University.This summer, Stanford adopted the UF&Shands model for routine genetic testing for cath lab patients. Also, the two universities collaborated to develop a custom chip for use in testing a patient’s response to clopidogrel. The chip is used to collect and screen DNA samples for the seven suspected genetic variations.
A Clinical and Translational Science Awards grant of nearly $500,000 funded the creation of the UF CTSI Personalized Medicine Program. It also funded the collaboration with Stanford. The awards program is led by the NIH’s National Center for Advancing Translational Sciences. Additional grant funding of more than $350,000 came through the NIH Pharmacogenomics Research Network.
This is another example of how advances in diagnostic technology, such as proteomics and genetic testing, can be seen as opportunities for pathologists and clinical laboratory managers to add value to physicians and directly improve diagnosis, choice of therapy, and patient outcomes.
—Pamela Scherer McLeod