FDA gives AI-powered blood test for obstructive CAD breakthrough device designation
Prevencio, a Washington-based healthcare company known for its artificial intelligence (AI)-based blood tests, has receive the FDA’s breakthrough device designation for its new HART CADhs test.
The breakthrough devices program is designed to help medical devices make it through the approval process faster than they would otherwise. FDA representatives work directly with the manufacturer, for example, and all submissions are prioritized.
HART CADhs is a multi-protein test that includes advanced AI algorithms capable of detecting signs of obstructive coronary artery disease (CAD) in heart patients. Researchers with Massachusetts General Hospital (MGH) used Prevencio’s HART platform to develop and train the new test. According to Prevencio, HART CADhs has an area under the ROC curve for detecting CAD of 0.86, which significantly higher than what clinicians see with traditional testing methods such as stress echocardiography and nuclear imaging.
HART CADhs is available now as a laboratory developed test with a turnaround window of two to 10 days. Prevencio’s goal is to gain full FDA approval and offer the test as an in vitro diagnostic with a one-hour turnaround time.
“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,” HART researcher James L. Januzzi, MD, a practicing cardiologist at MGH, professor of medicine at Harvard Medical School, and chief scientific officer at the Baim Institute for Clinical Research, said in a statement. “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.”
“The FDA’s breakthrough device designation is a pivotal milestone in our mission to revolutionize the diagnosis and treatment of obstructive CAD,” added Rhonda Rhyne, president and CEO 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.”
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.