AI Imaging Giant Cleerly Adds Genetic Testing to Build Comprehensive Heart Disease Risk Platform

Cleerly, the AI-powered cardiac imaging company, is expanding beyond its FDA-cleared coronary CT analysis platform with a strategic move into genetic testing. Through a new partnership with Allelica, the company has launched the Cleerly Polygenic Cardiovascular Risk Score Test, a CLIA-certified genetic assay that identifies inherited predisposition to coronary artery disease from saliva samples. The test can function independently or integrate with Cleerly's existing AI-enabled imaging technology, creating a dual-modality approach to cardiovascular risk assessment.

The collaboration addresses a critical gap in early detection: identifying high-risk individuals before significant plaque accumulation occurs. Validation studies identified up to one in four individuals as having high genetic risk for coronary artery disease, with real-world imaging data showing these patients developed coronary plaque nearly two decades earlier than those with low genetic risk.

Bridging Genetics and Imaging for Earlier Intervention

The Cleerly Polygenic Cardiovascular Risk Score Test analyzes genetic variants across the genome to estimate inherited CAD risk, powered by Allelica's multi-ancestry polygenic risk score technology. Unlike many genetic tests calibrated primarily for European-ancestry populations, this assay has been validated for diverse and admixed populations—a significant advancement for precision cardiology equity.

When paired with Cleerly's FDA-cleared AI-enabled quantitative coronary CT platform, physicians gain a comprehensive view combining inherited predisposition with anatomical plaque assessment. Cleerly's imaging technology quantifies total plaque burden and characterizes both calcified and non-calcified plaque, providing more detailed information than traditional coronary artery calcium scoring, which only detects calcified deposits.

Multiple peer-reviewed studies demonstrate that individuals with high polygenic risk scores carry greater burdens of non-calcified, rupture-prone plaque—the type most associated with acute cardiac events. This correlation between genetic risk and plaque characteristics underscores the clinical value of combining both assessment modalities.

Strategic Positioning in Competitive Cardiovascular Market

Cleerly's expansion into genetic testing represents a calculated competitive strategy. While numerous companies focus exclusively on either AI imaging or genetic risk assessment, Cleerly is building a more comprehensive platform that addresses cardiovascular risk from multiple angles.

"The integration of polygenic risk scores with advanced coronary imaging represents a paradigm shift in how we approach cardiovascular disease prevention," said James K. Min, M.D., Cleerly's Founder and CEO. The partnership with Allelica allows Cleerly to offer this capability without developing genetic testing infrastructure internally, leveraging Allelica's established CLIA-certified laboratory operations.

The test is currently available to U.S. physicians as a laboratory-developed test performed under CLIA certification. While not FDA-authorized—not currently required for CLIA tests—the company emphasizes the test is not diagnostic but rather provides risk stratification information to guide preventive care decisions.

Clinical Implications for Preventive Cardiology

The greatest clinical impact may be in younger adults, where early identification of high genetic risk enables decades of preventive intervention before significant disease develops. Traditional cardiovascular screening often begins in middle age, potentially missing critical windows for lifestyle modification and preventive therapies in genetically predisposed individuals.

Physicians now have flexibility to deploy genetic testing independently for initial risk stratification or integrate it with advanced imaging based on individual patient protocols and clinical presentation. This personalized approach aligns with broader trends toward precision medicine in cardiovascular care, moving beyond one-size-fits-all screening algorithms toward individualized risk assessment.

As the cardiovascular AI market continues to evolve, Cleerly's multi-modality strategy positions the company to capture a larger share of the prevention and early detection market, particularly as healthcare systems increasingly prioritize upstream interventions over costly downstream treatments.

Sources

1. Cleerly, Allelica Partner on Risk Score Test for Coronary Artery Disease — MPO Magazine