The First Gene Based Project to be conducted in the Rio Grande Valley

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Edinburg, TX – Can a medical tool predict the risk of certain medications based on a patient’s genetics, and, if so, could this information lead to doctors customizing a patient’s drug therapy? The tool being studied at DHR Health Institute for Research & Development to answer these questions is Cipherome’s Xentinel® Lighthouse, and this pilot study will also evaluate the resulting savings in health-care costs.

After a stroke or heart attack, the standard treatment is Percutaneous Coronary Intervention (PCI), or stent placement. A stent opens blood vessels in the heart that have narrowed due to the buildup of plaque. Following PCI, doctors typically prescribe aspirin and a P2Y12 inhibitor, such as clopidogrel (Plavix), to reduce the risk of stent thrombosis, which is the formation of a blood clot on the surface of the stent.

Lighthouse is a support tool that allows physicians to predict how a patient will respond to drug therapies based on that patient’s genetic makeup. Cipherome, Inc. chose South Texas for this pilot project to better understand how the genetic differences in Hispanic/Latino patients relate to the effectiveness and safety of medications used to treat them.

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“Most prior studies to anticipate major bleeding caused by this drug therapy have been based on data collected from Caucasian patients, have not been based on a  patient’s individual risk profile, and have not been strong predictors of thrombosis risk,” says Dr. Herschl Silberman, a cardiologist at DHR Health and a Clinical Research Scientist, DHR Health Institute for Research & Development. “This lack of effective clinical tools has resulted in high numbers of emergency room visits and patients being readmitted to the hospital with stent thrombosis, bleeding, and other complications.”

In 2019 alone, over 1.5 million patients visited an emergency room or were hospitalized due to unexpected reactions to drug therapies, and 174,000 people in the U.S. lost their lives due to these adverse reactions. Recent studies show the possibility of an 80-percent reduction in PCI 90-day complications by using a patient’s personalized genetic information.

“Personalized medicine brings great promise to improve outcomes for our patients and we are focused on pioneering innovative practical solutions that can produce better results for our clinicians and patients,” says Dr. Sohail Rao, CEO of DHR Health Institute of Research and Development (DHR IRD). “DHR IRD’s credibility and service to the large Hispanic population in South Texas is the ideal place for our first deployment of clinical decision support systems,” says Ilsong Lee, Cipherome CEO.

This study is open to patients 18 years of age and older who have been prescribed clopidogrel, prasugrel (Effient®), or ticagrelor (Brilinta®) after a PCI with at least one stent placement. There are two study arms, or groups, one receiving clopidogrel but no genotyping to identify the patient’s genetic makeup and the other receiving genotype-guided therapy. Patients in the study will be evaluated for a period of one year.

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