UAB Cardiogenomics Clinic and Allelica to perform polygenic risk score clinical implementation study

The Cardiogenomics Clinic at the University of Alabama at Birmingham and Allelica are partnering to perform a clinical implementation study to assess how polygenic risk score integration changes clinical management and health outcomes in a US health system.

NEW YORK, Nov. 29, 2022 /PRNewswire/ -- The UAB Cardiogenomics Clinic, led by Dr. Pankaj Arora, is partnering with the industry leader for polygenic risk score (PRS) analysis and reporting, Allelica Inc., to perform a clinical implementation study on PRS application for coronary artery disease. The aim of the study is to develop a clear path forward for the clinical implementation of PRS in cardiovascular disease prevention.

This study will assess the real world value of PRS analysis for the most prevalent life-threatening common disease around the world, coronary artery disease (CAD). While scientific evidence of the potential of PRS to improve CAD prevention has been demonstrated through years of extensive clinical research, widespread adoption of PRS in US health systems has not yet become mainstream. Some of the main barriers to widespread adoption include lack of education, unclear clinical implementation guidelines and concerns about PRS applicability across ancestries.

The results of this study will help to establish a clear pathway for providers for the clinical implementation of PRS in cardiovascular disease risk management and prevention.

The UAB Cardiogenomics Clinic will offer PRS testing for CAD to a cohort of healthy patients who are interested in learning more about their personal health profiles and actively taking control of prevention. PRS testing services will be provided by Allelica through the collaboration of their CLIA, CAP laboratory partner, Eurofins Clinical Enterprise, in Framingham, MA. PRS for CAD will be calculated on Allelica's software.

The Allelica software performs PRS analyses using Allelica's proprietary multi ancestry PRS for CAD, developed and validated in prospective datasets comprising individuals of multiple ancestries. The results are delivered to providers through a secure portal. Providers then deliver the results to the patients and discuss prevention strategies.

The UAB Cardiogenomics Clinic, a leading innovator and provider of precision medicine, has had PRS on their radar as a method for increasing precision in CAD risk assessment for some time. The Cardiogenomics Clinic guides patients through their unique genetic risk profile and offers genetic counseling services. The study will expand the Clinic's current service portfolio and provide evidence and recommendations for using CAD PRS in the standard of care.

"This is a unique opportunity for the patients in the southeast to get a personalized genetic risk assessment for their lifetime risk of developing heart attacks. The southeast US, including Alabama, has the highest rates of heart disease related deaths in the nation. The main goal for us is to utilize PRS to create a personalized prevention plan for the patients to reduce their risk of developing a potentially fatal heart disease event. We are now one of the few sites in the entire United States where patients can get this one-time assessment of their genetic risk of developing heart attacks," explained Dr. Pankaj Arora. Dr. Arora, who also directs the UAB Cardiovascular Clinical and Translational Research program, highlighted the importance of clinical research in developing a state-of-the-art precision cardiovascular medicine center for the patients in the southeastern US. He added, "Clinical research is central to improving the implementation of such nuanced personalized tools. Hence, we are collaborating with leaders across the nation to bring the advances in genomic medicine such as the PRS to the doorstep of every patient."

As part of a study, both patients and providers will be surveyed through a digital questionnaire one month after result delivery to assess their reactions and perceived usefulness of the PRS results. After one year, patients' biophysical and lifestyle measures will be evaluated to determine if the integration of PRS analysis and reporting in the clinical pathway had any impact on the patient's personal risk mitigation actions.

Allelica CEO, Giordano Bottà, sees this study as a crucial step in the widespread adoption of PRS. "This study enables us to produce evidence of the real world value of PRS in the prevention of common disease. The physicians at UAB will be setting new standards for healthcare providers across specialties for the incorporation of PRS."

Allelica and UAB plan to expand the study by partnering with multiple preventive cardiology sites across the US. Expansion of the study will enable more robust results through the participation of more diverse patients and a wider pool of physicians.

For more information on the study or to find out how to participate as a study site, please contact Allelica at [email protected].

Allelica is a leading genomic software company that specializes in secure and scalable solutions to implement clinical-grade polygenic risk scores (PRSs) in multiple ancestries. Allelica's technology combines world-class datasets with the most advanced algorithms to build PRSs with the highest predictive power for estimating disease risk. Allelica's tools translate the enormous potential of genomic data into practical tools that can be used to identify individuals with a high genetic susceptibility for life-threatening diseases. Through the incorporation of genetics into disease risk assessments, Allelica is helping to build the foundations of preventive medicine by helping to identify those for whom early intervention and behavior modification could help reduce lifetime risk. To learn more, visit allelica.com.

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SOURCE Allelica, Inc.