Prevencio Receives FDA Breakthrough Device Designation for HART CADhs, Its Artificial Intelligence-driven Blood Test for Obstructive Coronary Artery Disease

KIRKLAND, Wash., May 13, 2025--(BUSINESS WIRE)--Prevencio, Inc., the leader in artificial intelligence-powered blood tests for cardiovascular diagnostics, announces that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its HART CADhs® test. This designation recognizes HART CADhs as an innovative technology for identifying obstructive coronary artery disease (CAD)—a condition responsible for significant morbidity and mortality. The designation is reserved for technologies that offer significant advantages over existing solutions and address unmet medical needs.
HART CADhs is the only AI-based multi-protein blood test capable of accurately detecting blockage in the heart's arteries. By combining multiple cardiac proteins with proprietary machine learning algorithms, HART CADhs delivers actionable insight through a simple, 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," said Rhonda Rhyne, President and Chief Executive Officer of Prevencio. "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 2 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 only 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," said James L. Januzzi, MD, 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 over $318 billion in annual U.S. healthcare costs, nearly 10% of total healthcare spending. Prevencio's HART blood tests are designed 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.
About Prevencio HART Tests: Powered by AI, Prevencio is revolutionizing cardiac diagnostics with AI-driven blood tests for cardiovascular disease and custom diagnostics for diagnostic, medical device and pharmaceutical companies. Using this novel approach, the company has developed seven blood tests that significantly improve diagnosis and risk assessment for a variety of heart and blood vessel-related complications.
HART test results have been peer-reviewed published 35 times, including at leading 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 top-tier 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).
About Prevencio, Inc.
Prevencio's vision is to revolutionize cardiac diagnostics with AI-driven blood tests—thereby improving care with highly accessible, accurate and cost-effective diagnosis and earlier treatment. Prevencio utilizes Machine Learning (Artificial Intelligence) + Multi-Proteomic Biomarkers + Proprietary Algorithms to deliver diagnostic & prognostic tests that are significantly more accurate than standard-of-care stress tests, genetic risk scores and coronary artery calcium. The company is headquartered in Kirkland, Washington. For additional information, visit Prevencio, Inc.
Forward-Looking (Safe Harbor) Statement:
Except for historical and factual information contained herein, this press release contains forward-looking statements, such as market need, acceptance, and size, the accuracy of which is necessarily subject to various uncertainties of development-stage companies. The company does not undertake to update disclosures contained in this press release.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250513396732/en/
Contacts
Christiaan Boer, cboer@cplusc.com; 206-557-4309

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