Cleerly and Allelica launch a new tool for assessing genetic risk in heart patients

Michael Walter | July 30, 2026 | Cardiovascular Business | Care Delivery

A majority of medical devices involved in Class I recalls were never required by the U.S. Food and Drug Administration (FDA) to undergo premarket or postmarket clinical testing, according to new research published in Annals of Internal Medicine.[1]

Cleerly, a Denver-based artificial intelligence (AI) company, has partnered with New York-based Allelica to launch the new Cleerly Polygenic Cardiovascular Risk Score Test.

Allelica specializes in polygenic risk scores (PRS) that predict a patient’s genetic risk of developing different diseases. Cleerly, meanwhile, its known for its AI-powered coronary CT angiography (CCTA) evaluations. Together, these two companies have collaborated on a new test designed to help physicians diagnose and manage heart patients with suspected coronary artery disease.

“Genetic risk and imaging answer two different questions for a physician,” James K. Min, MD, FACC, FESC, MSCCT, founder and CEO of Cleerly, said in a statement. “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.”

“PRS can help us identify individuals whose arteries are biologically predisposed to develop dangerous plaque," added Giordano Bottà, CEO of Allelica. “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.”

How does the new test work?

The Cleerly Polygenic Cardiovascular Risk Score Test is designed to be used on its own or in tandem with Cleerly’s AI-powered CCTA evaluations. Patients provide a saliva sample, and the test is performed in a laboratory that meets certain Clinical Laboratory Improvement Amendments quality standards.

Allelica’s multi-ancestry PRS capabilities are intended to take this risk score beyond other genetic tests, ensuring as much information can be extracted from the patient’s sample as possible.

This new test is now available to U.S. physicians.