Cleerly, Allelica Partner on Risk Score Test for Coronary Artery Disease

 Cleerly and Allelica are teaming up to launch the Cleerly Polygenic Cardiovascular Risk Score Test, powered by Allelica. The assay provides physicians with a new option to identify and evaluate individuals with an inherited predisposition to coronary plaque.

The Cleerly Polygenic Cardiovascular Risk Score Test can be used on its own or alongside Cleerly’s AI-enabled quantitative coronary CT (AI-QCT) analysis. The two are complementary, but each is available independently; used together, they allow physicians to consider inherited genetic risk alongside advanced coronary imaging, thus extending cardiovascular assessment beyond traditional risk factors.

How the Test Works

The Cleerly Polygenic Cardiovascular Risk Score Test is performed in a CLIA-certified laboratory. When ordered by a qualified healthcare provider, it uses a saliva sample to analyze genetic variants across an individual’s genome and estimate their inherited risk of developing coronary artery disease (CAD). Built on Allelica’s multi-ancestry PRS, the score is calibrated for use across diverse and admixed populations, making it one of the few PRS tools validated beyond European-ancestry populations. In validation, it flagged as many as one in four individuals as being at high genetic risk of coronary artery disease.¹

For physicians who choose to pair genetic insight with imaging, Cleerly’s U.S. Food and Drug Administration (FDA)-cleared, artificial intelligence (AI)-enabled platform analyzes coronary CT angiography (CCTA) scans to quantify total plaque burden and characterize plaque composition, including non-calcified plaque. Unlike coronary artery calcium (CAC) scoring, which identifies only calcified plaque, Cleerly’s analysis also characterizes non-calcified plaque, giving physicians a comprehensive, quantitative picture of what is present in the arteries.

“Genetic risk and imaging answer two different questions for a physician,” Cleerly Founder/CEO James K. Min, M.D., said. “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.”

Multiple peer-reviewed studies have shown that individuals with high polygenic risk scores carry a greater burden of non-calcified, rupture-prone plaque than those at lower genetic risk.^2,3 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, where preventive intervention has the greatest potential impact.⁴

The Cleerly Polygenic Cardiovascular Risk Score Test gives physicians another way to personalize preventive cardiovascular care. A physician may use it to identify individuals with a high inherited risk of CAD and, where appropriate, use AI-enabled coronary CT imaging to characterize and evaluate coronary plaque. Since the two are independent, physicians can use either on its own, based on the appropriate protocols for each patient.

“Polygenic risk scores can help us identify individuals whose arteries are biologically predisposed to develop dangerous plaque,” Allelica CEO Giordano Bottà stated. “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.”

The Cleerly Polygenic Cardiovascular Risk Score Test is currently available to U.S. physicians. 

The Cleerly Polygenic Cardiovascular Risk Score Test is a laboratory-developed test performed under CLIA and has not been authorized by the FDA, as such approval is not currently required for CLIA tests. The assay is not diagnostic but rather is intended to provide physicians with additional information about a patient’s inherited coronary artery disease risk. Test performance may vary across ancestry groups.

Allelica is a precision medicine company specializing in multi-ancestry polygenic risk scores (PRS) to predict genetic risk for common diseases in diverse populations. By integrating advanced bioinformatics with large-scale genomic data, Allelica empowers physicians and healthcare systems to reduce the burden of common diseases. Its technology is supported by major publications, five patents, and adoption by healthcare systems.

Cleerly aims to eliminate heart attacks by creating a new care standard for heart disease. Through its FDA-cleared solutions driven by AI, Cleerly supports comprehensive phenotyping of coronary artery disease, as determined from advanced noninvasive CT imaging. Cleerly’s approach is grounded in science, based on millions of images from more than 40,000 patients. Led by a clinical and technical team, Cleerly enhances health literacy for every stakeholder in the coronary care pathway.

References
¹ Busby GB, Kulm S, Bolli A, et al. Ancestry-specific polygenic risk scores are risk enhancers for clinical cardiovascular disease assessments. Nature Communications. 2023;14:7105. https://doi.org/10.1038/s41467-023-42897-w
² Cornelissen A, Gadhoke NV, Ryan K, et al. Polygenic Risk Score Associates With Atherosclerotic Plaque Characteristics at Autopsy. Arterioscler Thromb Vasc Biol. 2024;44(1):300–313. https://doi.org/10.1161/ATVBAHA.123.319818
³ Nurmohamed NS, Shim I, Gaillard EL, et al. Polygenic Risk Is Associated With Long-Term Coronary Plaque Progression and High-Risk Plaque. JACC Cardiovasc Imaging. 2024;17(12):1445–1459. https://doi.org/10.1016/j.jcmg.2024.06.015
⁴ Petranovic M, Lai YP, Huck D, et al. Use of a polygenic risk score to enhance early detection of coronary atherosclerosis. Am J Prev Cardiol. 2026;29:101578. https://doi.org/10.1016/j.ajpc.2026.101578