A novel, multi-protein blood test was shown to be substantially more accurate than standard diagnostic methods, such as ECG and nuclear stress testing, in identifying coronary artery disease. The test was also successful in identifying the presence of significant coronary obstruction 90% of the time.
The test, called the ‘HART coronary artery disease (CAD)’ was developed by Prevencio researchers and Massachusetts General Hospital. The trial examined over 900 subjects, each tested for the presence of an obstruction of ≥70% in at least one major coronary artery.
Speaking on the tests accuracy, lead investigator James L. Januzzi, MD, said: “These are significant results which have the potential to establish a new standard of care and the potential to save millions of lives.”
As well as improving accuracy, the novel test has the potential to lower medical testing costs. Standard diagnostic test costs are currently high, with a cardiac computed tomography (CT) angiogram procedure costing $2,000 on average, and a cardiac catheterization costing $47,000 on average.
In addition to the HART CAD test for diagnosis, Prevencio is developing blood tests for predicting, with an aim to preventing, the likelihood a patient will suffer from a heart attack, stroke, or cardiovascular death within one year.
Prevencio plans to conduct FDA trials in 2018, and subsequently file for FDA approval in 2018–2019. The company predicts that the HART CAD panel will be available to medical professionals for use by 2019. “We look forward to finalizing the testing kit, conducting our pivotal FDA trial and bringing HART CAD to medical professionals around the world,” said president and CEO of Prevencio, Rhonda Rhyne.
Prevencio, Inc. data published in Journal of the American College of Cardiology (JACC) shows new blood est predicts significant heart disease 90 percent of the time, also predicts risk of future heart attack [news release]. Kirkland, WA: Prevencio, Inc. http://www.businesswire.com/news/home/20170227005276/en. Published February 27, 2017. Accessed February
This article originally appeared on MPR