Allelica Partners with Mass General Brigham for PROACT 3 Trial Testing Polygenic Risk Score Impact on Cardiovascular Prevention
核心洞察
Allelica (搜索) has been selected as the polygenic risk score testing collaborator for the PROACT 3 clinical trial at Mass General Brigham (搜索), led by Dr. Akl Fahed.
The randomized trial will enroll 500 adults without cardiovascular disease to evaluate how coronary artery disease polygenic risk score disclosure influences LDL cholesterol levels and preventive behaviors.
PROACT 3 addresses a critical question in preventive genomics by testing real-world implementation of genetic risk scoring in a large health system setting.
Allelica (搜索), the global leader in multi-ancestry clinical polygenic risk score (PRS) testing, has been selected as the PRS testing collaborator for the PROACT 3 clinical trial at Mass General Brigham (搜索). Led by principal investigator Dr. Akl Fahed of Massachusetts General Hospital and Harvard Medical School, the trial represents a significant step forward in evaluating the real-world clinical utility of genetic risk assessment for cardiovascular disease prevention.
Trial Design and Objectives
PROACT 3 will evaluate how the disclosure of coronary artery disease (CAD) polygenic risk score influences LDL cholesterol levels, cardiovascular health, preventive behaviors, and engagement with care. The randomized trial will enroll 500 adults without cardiovascular disease who are not currently on LDL cholesterol lowering therapy, recruited through the Mass General Brigham (搜索) primary care network.
All participants will receive Allelica (搜索)'s multi-ancestry CAD PRS and are randomized to either immediate disclosure or disclosure after 12 months. The trial's primary outcomes include changes in LDL cholesterol levels and cardiovascular health behaviors over the 12-month period.
"The objective of the PROACT 3 study is closely aligned with our company's mission to empower healthcare providers with safe diagnostics that improve patient care and ultimately save lives," said Dr. Giordano Botta, CEO & Co-Founder of Allelica (搜索).
Building on Previous Research
PROACT 3 follows a series of ongoing PROACT trials examining the clinical impact of polygenic risk assessment. The NIH-funded PROACT 1 and 2 trials (Polygenic Risk Based Detection and Treatment of Subclinical Coronary Atherosclerosis) are conducted within the Mass General Brigham (搜索) Biobank and examine the impact of high genetic risk on change in cardiovascular health and detection and treatment of subclinical coronary atherosclerosis.
PROACT 3 is testing real-world implementation in the context of a large health system, addressing an essential and understudied question in preventive genomics: does receiving a genetic risk score improve key cardiovascular measures and behaviors?
Multi-Ancestry Polygenic Risk Score Technology
The Allelica (搜索) multi-ancestry CAD PRS used in the study was published in Nature Communications in late 2023 and is currently being used by providers nationwide. The test identifies individuals who are missed by standard clinical models but carry elevated genetic risk, making them appropriate candidates for early intervention with lipid-lowering therapies.
Built to ensure accuracy across diverse populations, the technology enables providers to offer patients personalized risk stratification and supports early intervention for those most at risk of heart disease. This multi-ancestry approach addresses a critical gap in genetic testing, which has historically been less accurate for non-European populations.
Clinical Significance
"Allelica (搜索) is proud to support Dr. Fahed and his team as they expand the evidence of clinical utility of CAD polygenic risk score testing in cardiovascular prevention," said Dr. Botta. The partnership reflects the company's commitment to develop and validate advanced diagnostics with proven clinical utility.
Allelica (搜索) specializes in multi-ancestry polygenic risk scores to predict genetic risk for common diseases in diverse populations. By integrating advanced bioinformatics with multi-ancestry PRS, the company aims to empower physicians and healthcare systems to reduce the burden of and deaths caused by common disease.