Kirkland, Wash. — The U.S. Food and Drug Administration (FDA) has awarded Breakthrough Device Designation to Prevencio Inc.’s HART CADhs®, an artificial intelligence-based blood test designed to detect obstructive coronary artery disease (CAD), the company announced Monday.
HART CADhs is the only test of its kind that combines multiple cardiac protein biomarkers with proprietary machine learning algorithms to identify blocked arteries through a simple blood draw. The test aims to provide a faster, more accurate alternative to traditional diagnostic tools such as stress echocardiograms and nuclear imaging.
The FDA’s Breakthrough Device program is intended for technologies that offer significant advantages over existing methods for serious or life-threatening conditions. The designation grants Prevencio access to expedited review and closer collaboration with the agency as it works toward gaining clearance for a rapid in vitro diagnostic version of the test, which could deliver results in about an hour.
“The FDA’s recognition of HART CADhs as a breakthrough device is a critical step toward transforming how we diagnose and manage coronary artery disease,” said Rhonda Rhyne, president and CEO of Prevencio. “We are working to expand use beyond outpatient settings to emergency departments, where early and accurate diagnosis can be life-saving.”
Currently offered as a lab-developed test with a two-to-ten-day turnaround, HART CADhs has shown strong performance in clinical studies, including a collaboration with Massachusetts General Hospital. The test demonstrated an area under the curve (AUC) of 0.86 for detecting obstructive CAD—compared to 0.52 for some standard tests—suggesting it may significantly outperform existing diagnostic tools.
James L. Januzzi, MD, a cardiologist at Massachusetts General Hospital and lead investigator for HART test development, noted the test’s potential to improve care in both emergency and outpatient settings. “Nearly half of U.S. counties lack access to a cardiologist, and urban wait times are long,” Januzzi said. “A simple, accurate blood test like HART CADhs could help close that gap and improve early diagnosis and intervention.”
Cardiovascular disease remains the leading cause of death globally. The American Heart Association estimates that cardiovascular disease and stroke cost the U.S. over $318 billion annually. Prevencio’s suite of AI-driven tests aims to reduce this burden by enabling earlier, more accessible diagnostics.
In addition to HART CADhs, the company offers HART CVE®, a blood test that predicts a patient’s one-year risk of heart attack, stroke, or cardiovascular death. Both tests are currently available to healthcare providers.
