AI-Driven Blood Test for Obstructive CAD Awarded FDA Breakthrough Designation

Prevencio Inc. has secured U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its HART CADhs test, which employs artificial intelligence (AI) to identify obstructive coronary artery disease (CAD).

HART CADhs reportedly is the only AI-based multi-protein blood test that can accurately detect coronary artery blockages. By combining multiple cardiac proteins with proprietary machine learning algorithms, HART CADhs detects the disease through a non-invasive blood draw, bridging critical diagnostic gaps in current cardiovascular care.

“The FDA’s Breakthrough Device Designation is a pivotal milestone in our mission to revolutionize the diagnosis and treatment of obstructive coronary artery disease,” Prevencio President/CEO Rhonda Rhyne said. “We are committed to expanding the use of HART CADhs from outpatient settings into emergency care environments to ensure that patients receive earlier, more accurate, and potentially life-saving diagnoses.”

HART CADhs is currently available as a Lab Developed Test (LDT) with a two to 10-day turnaround, making it ideal for evaluating stable, non-urgent patients. The Breakthrough Device Designation enables close collaboration with the FDA and an expedited review process, supporting Prevencio’s goal to advance the test into a rapid, FDA-cleared in-vitro diagnostic (IVD) with a one-hour result time—ideal for evaluating chest pain patients in emergency rooms.

HART CADhs was developed using Prevencio’s proprietary HART platform in collaboration with researchers at Massachusetts General Hospital (MGH). In clinical research, the test demonstrated high accuracy (0.86 AUC) in detecting obstructive CAD, significantly outperforming standard-of-care tests such as stress echocardiography and nuclear imaging, which yielded 0.52 AUC.

“With nearly half of U.S. counties lacking access to a cardiologist and long wait times in urban centers, a simple, accurate blood test to diagnose obstructive CAD offers tremendous potential to improve access to early diagnosis and intervention,” stated James L. Januzzi, M.D., a practicing cardiologist at MGH, professor of Medicine at Harvard Medical School, chief scientific officer at the Baim Institute for Clinical Research and principal investigator for the HART test development and validation. “Our studies show HART CADhs is informative in a broad range of patient types including those with acute symptoms as well as those not diagnosed with a heart attack yet may have dangerous arterial obstruction. This suggests usefulness in both acute and outpatient settings.”

Cardiovascular disease remains the leading cause of death in the United States and worldwide. According to the American Heart Association, cardiovascular disease and stroke account for more than $318 billion in annual U.S. healthcare costs, nearly 10% of total healthcare spending. Prevencio’s HART blood tests aim to improve patient outcomes and reduce costs through earlier, more accurate, and more accessible diagnostics.

In addition to HART CADhs, Prevencio also offers HART CVE, a second AI-driven, multi-protein blood test that assesses a patient’s one-year risk of heart attack, stroke, or cardiovascular death. Both tests are currently available to healthcare providers.

Powered by AI, Prevencio has developed seven blood tests designed to significantly improve diagnosis and risk assessment for various heart and blood vessel-related complications. HART test results have been peer-reviewed published 35 times, including at cardiovascular meetings—(European Society of Cardiology Congress; American College of Cardiology Scientific Sessions; American Heart Association Scientific Sessions; American Diabetes Association Scientific Sessions; and Transcatheter Cardiovascular Therapeutics Sessions) and in clinical journals—(Journal of American College of Cardiology; American Journal of Cardiology; Clinical Cardiology; Biomarkers in Medicine; Journal of American Heart Association; and European Journal of Preventive Cardiology).

Prevencio’s uses machine learning (artificial intelligence), multi-proteomic biomarkers, and proprietary algorithms to deliver diagnostic and prognostic tests that are significantly more accurate than standard-of-care stress tests, genetic risk scores, and coronary artery calcium, according to the Kirkland, Wash.-based company.