KIRKLAND, Wash.--(BUSINESS WIRE)--Prevencio, Inc. today announces the publication of data that demonstrates that a simple blood test is substantially more accurate in diagnosis of heart disease than standard diagnostic methods, delivering results in only two hours. Researchers believe the data, published in Journal of the American College of Cardiology (JACC), could lead to improved diagnosis of obstructive coronary artery disease (CAD), lower disease and death rates, and lower healthcare costs.
In the study, Prevencio researchers and Massachusetts General Hospital developed a clinical and multi-protein blood test, HARTTM CAD, to diagnose a patient’s likelihood of having clinically significant obstruction of the coronary arteries which could require invasive intervention to possibly prevent a heart attack or death. Lead author and Principal Investigator James L. Januzzi, MD, is a practicing cardiologist at Massachusetts General Hospital and Professor of Medicine at Harvard Medical School.
Januzzi and a team of researchers tested more than 900 subjects for the presence of obstruction of 70 percent or more in at least one major coronary artery – the threshold for medical intervention. A positive result with the new diagnostic test indicated the presence of significant coronary obstruction 90 percent of the time, and also predicted risk of future heart attack.
“These are significant results which have the potential to establish a new standard of care and the potential to save millions of lives,” said Januzzi. “With better diagnostic and predictive methods, we can aim to better diagnose coronary artery disease, initiate therapy and lifestyle change earlier, and possibly prevent complications such as heart attacks, while simultaneously improving a patient’s quality of life.”
Coronary artery disease is the leading cause of death in the U.S. and globally. According to the American Heart Association, heart disease kills more than 370,000 Americans per year, and in 2015 cost more than $180 billion in U.S. healthcare.
Prevencio’s HART CAD test was substantially more accurate for predicting heart disease than standard diagnostic methods such as ECG and nuclear stress testing. Those tests are also problematic because they can be inaccurate in women and obese patients, and nuclear tests expose patients to ionizing radiation. Costs for standard diagnostic tests are also high, with a cardiac computed tomography (CT) angiogram procedure costing $2,000 on average, and a cardiac catheterization costing $47,000 on average in the U.S. According to a publication in the New England Journal of Medicine, almost 65 percent of patients are needlessly referred for invasive coronary catheterization, subjecting them to ionizing radiation and serious complications, including death.
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.
“It is personally rewarding to work with such a talented team of dedicated researchers to find a safer, more accurate and more affordable way to diagnose and treat millions of cardiac patients,” said Rhonda Rhyne, President and Chief Executive Officer of Prevencio. “We look forward to finalizing the testing kit, conducting our pivotal FDA trial and bringing HART CAD to medical professionals around the world.”
Prevencio is developing its standardized lab test for HART CAD and plans to conduct FDA trials in 2018, then file for European and FDA approval in 2018-2019. The HART CAD panel will potentially be available to medical professionals for use by 2019.
About Prevencio, Inc.:
Prevencio’s mission is to prevent the preventable – improving patient outcomes and reducing healthcare costs by preventing unnecessary cardiac procedures and procedure-related side effects, as well as predicting — and hopefully thereby preventing — one year adverse cardiac events. The company is a pioneer in diagnostic and predictive tests for cardiovascular disease and related adverse events. Prevencio’s proprietary HART™ CAD Test is a first-in-class product. The company is headquartered in Kirkland, Washington. For additional information on Prevencio, visit www.PrevencioMed.com. Prevencio—Preventing the Preventable.™
Forward-Looking (Safe Harbor) Statement:
Except for historical and factual information contained herein, this press release contains forward-looking statements, such as market need, acceptance, size, potential, growth and penetration rates, the accuracy of which is necessarily subject to uncertainties and risks including the Company’s sole dependence on HART technology and various uncertainties characteristic of development-stage companies. The Company does not undertake to update the disclosures contained in this press release.