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Diseases

Prevencio's HART CADhs Test Receives FDA Breakthrough Device Designation

Strategic Insights

— 2 min read

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Prevencio's HART CADhs test, a blood test that uses artificial intelligence to detect obstructive coronary artery disease (CAD) through a simple, non-invasive blood draw. This designation recognizes HART CADhs as an innovative technology that offers significant advantages over existing solutions and addresses unmet medical needs. The test is currently available as a Lab Developed Test (LDT) with a 2 to 10-day turnaround, and 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.

Key Takeaways:

  • HART CADhs is the only AI-based multi-protein blood test capable of accurately detecting blockage in the heart's arteries, with a high accuracy of 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.
  • The test is reserved for evaluating stable, non-urgent patients and is ideal for assessing a broad range of patient types, including those with acute symptoms and those not diagnosed with a heart attack yet may have dangerous arterial obstruction.
  • 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 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.
  • 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, including HART CADhs, are designed to improve patient outcomes and reduce costs through earlier, more accurate, and more accessible diagnostics.
  • Prevencio's vision is to revolutionize cardiac diagnostics with AI-driven blood tests, improving care with highly accessible, accurate, and cost-effective diagnosis and earlier treatment.

Statistics:

  • 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.
  • The test has a high accuracy of 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.
  • Cardiovascular disease remains the leading cause of death in the United States and worldwide, with over $318 billion in annual U.S. healthcare costs, nearly 10% of total healthcare spending.
  • The test is currently available as a Lab Developed Test (LDT) with a 2 to 10-day turnaround.

Sources:

  • "Prevencio Announces FDA Breakthrough Device Designation for HART CADhs Test" (businesswire.com)
  • "HART CADhs Test: A Breakthrough in Cardiac Diagnostics" (prevencio.com)
  • "About Prevencio" (prevencio.com)
  • "About American Heart Association" (heart.org)
  • "About U.S. Food and Drug Administration" (fda.gov)

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