Polygenic Risk Score Test Estimates Inherited Coronary Artery Disease Risk

Integrating genomic insights with advanced imaging extends cardiovascular assessment beyond traditional risk factors to better characterize plaque burden and composition. A newly launched test now estimates inherited risk for coronary artery disease and can be used alone or in combination with AI-enabled coronary CT analysis.

The Cleerly Polygenic Cardiovascular Risk Score Test, powered by Allelica’s multi-ancestry polygenic risk score technology, is designed to help physicians identify and evaluate individuals with a genetic predisposition to coronary plaque. The test can be ordered independently or used alongside Cleerly’s artificial intelligence-enabled quantitative coronary CT (AI-QCT) analysis, allowing clinicians to consider inherited genetic risk and advanced coronary imaging together. The test is now available to physicians in the US.

Performed in a CLIA-certified laboratory using a saliva sample, the assay analyzes genetic variants across the genome to estimate inherited risk of developing coronary artery disease. Built on a multi-ancestry polygenic risk score, the approach is calibrated for diverse and admixed populations and is described as one of the few tools validated beyond European-ancestry populations. In validation, it identified as many as one in four individuals as being at high genetic risk.

For practices that pair genetics with imaging, Cleerly’s U.S. Food and Drug Administration (FDA)-cleared platform analyzes coronary CT angiography (CCTA) to quantify total plaque burden and characterize plaque composition, including non-calcified plaque. In contrast to coronary artery calcium (CAC) scoring, which detects only calcified plaque, this analysis provides a comprehensive, quantitative picture of what is present in the coronary arteries. The two offerings are complementary but available independently.

The test is a laboratory-developed test performed under CLIA and has not been cleared or approved by the FDA, as such approval is not currently required for tests performed under CLIA. It is not diagnostic and is intended to provide physicians with additional information about a patient’s inherited risk of coronary artery disease. Test performance may vary across ancestry groups.

Multiple peer‑reviewed studies cited by the companies report that individuals with high polygenic risk carry a greater burden of non‑calcified, rupture‑prone plaque than those at lower genetic risk. In a real‑world imaging cohort, people at high genetic risk developed coronary plaque on average nearly two decades earlier than those at low genetic risk, with the strongest association among younger adults. Together with AI‑enabled CCTA, the test offers an additional option to personalize preventive cardiovascular care.

“Polygenic risk scores can help us identify individuals whose arteries are biologically predisposed to develop dangerous plaque. Multiple imaging studies now show that people with high genetic risk not only have more non-calcified plaque, but that these plaques progress more rapidly toward rupture-prone states. This is precisely the population where identifying that inherited risk earlier can matter most, particularly in younger adults,” said Giordano Bottà, CEO of Allelica.

“Genetic risk and imaging answer two different questions for a physician. Inherited risk points to who is biologically predisposed to coronary disease, and our imaging analysis shows what is actually present inside the arteries. Bringing those two views together gives physicians a clearer, more individualized picture of each patient's coronary risk,” said James K. Min, MD, founder and CEO of Cleerly.

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