FDA Fast-Tracks AI Blood Test That Could Revolutionize CAD Diagnosis. May 13, 2025.
FDA Fast-Tracks AI Blood Test That Could Revolutionize CAD Diagnosis. May 13, 2025.
1. Breakthrough Device Designation:
The FDA granted breakthrough device designation to Prevencio’s AI-powered blood test, HART CADhs, for detecting obstructive coronary artery disease (CAD).
2. About the Test:
HART CADhs is a multi-protein blood test enhanced by advanced AI algorithms, designed to identify signs of obstructive CAD.
3. Performance:
The test demonstrated an AUC (Area Under Curve) of 0.86—superior to traditional tests like stress echo and nuclear imaging.
4. Development:
Developed in collaboration with Massachusetts General Hospital (MGH) using Prevencio’s AI HART platform.
5. Current Availability:
Currently offered as a laboratory-developed test with a 2–10 day turnaround time.
6. Future Goal:
Prevencio aims to gain full FDA approval and reduce the turnaround to 1 hour for use as an in vitro diagnostic.
7. Clinical Impact:
The test is effective in patients with acute symptoms as well as those with subclinical obstructive disease—making it useful in both ER and outpatient settings.
8. Access & Equity:
The test may help overcome limited access to cardiologists, especially in rural U.S. counties and urban areas with long wait times.
9. Company Vision:
Prevencio plans to expand use into emergency care, providing earlier and more accurate CAD diagnoses, potentially saving lives.
