Prevencio, Inc. has received FDA Breakthrough Device Designation for its HART CADhs test, marking a significant advancement in artificial intelligence-powered cardiovascular diagnostics. The designation recognizes HART CADhs as an innovative technology for identifying obstructive coronary artery disease (CAD), a condition responsible for significant morbidity and mortality.
Revolutionary AI-Based Diagnostic Technology
HART CADhs represents the only AI-based multi-protein blood test capable of accurately detecting blockage in the heart's arteries. The test combines multiple cardiac proteins with proprietary machine learning algorithms to deliver actionable insights through a simple, non-invasive blood draw, addressing 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."
Superior Clinical Performance
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 with 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.
Pathway to Emergency Care Implementation
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.
Dr. Januzzi noted that 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, suggesting usefulness in both acute and outpatient settings.
Addressing Healthcare Burden
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.
Comprehensive Diagnostic Portfolio
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.
The company has developed seven blood tests using its novel approach that significantly improve diagnosis and risk assessment for various heart and blood vessel-related complications. HART test results have been peer-reviewed and published 35 times, including presentations at leading cardiovascular meetings and publications in top-tier journals such as the Journal of American College of Cardiology and American Journal of Cardiology.
