KIRKLAND, Wash.--(BUSINESS WIRE)--Prevencio, Inc. today announces the presentation of data which demonstrate that a simple blood test is more accurate than commonly-used risk factors in determining whether a person will have a heart attack or major cardiac event. Researchers believe the data, presented at American College of Cardiology (ACC) Scientific Sessions, could lead to improved risk classification of patients, thereby allowing more aggressive therapy in higher-risk patients and avoiding expensive or invasive treatment in lower-risk patients.
In the study, Massachusetts General Hospital and Prevencio researchers developed and validated a multi-protein blood test, HART™ CVE, to predict a patient’s one-year risk of having a heart attack, stroke, or cardiovascular death. 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 occurrence of a heart attack, stroke, or cardiovascular death within one year. When the test score was divided into low-risk and high-risk categories, the test predicted with 97% accuracy (negative predictive value) that a low-risk patient would not have a heart attack or major cardiac event within one year.
“This new risk score test provides improved accuracy as compared to clinical risk factors and could be particularly useful for those patients with suspected or known stable heart disease, for which there are very few prognostic risk models,” said Januzzi. “In addition to leading to more appropriate care of patients, it could also have a role in ‘enriching’ pharmaceutical cardiac clinical trials, which could lead to lower trial costs and reduced time to complete clinical trials.”
Cardiovascular disease is the leading cause of death in the U.S. and globally. According to the American Heart Association, the U.S. spends approximately $316 billion annually on cardiovascular disease and stroke, or approximately 10% of the $3.2 trillion spent on total healthcare. Worse yet, by 2030, more than 40% of the U.S. adult population is projected to have cardiovascular disease.
In addition to the HART CVE test for one-year risk of a cardiac events, Prevencio is developing a multi-protein blood test, HART CAD, for diagnosing obstruction of the coronary arteries. HART CAD was shown to be more accurate than standard-of-care stress tests.
“Prevencio is honored to work with Massachusetts General Hospital’s talented team of dedicated researchers to find safer, more accurate and more affordable ways to identify and treat millions of cardiac patients,” said Rhonda Rhyne, President and Chief Executive Officer of Prevencio. “The American Heart Association recently issued a Scientific Statement on the transformative impact of proteomics on cardiovascular health and disease, and we are pleased to be at the forefront of using multi-protein tests to improve cardiovascular care.”
Prevencio plans to conduct regulatory trials in 2018, then file for European and FDA approvals in 2018-2019. The HART CVE and HART CAD tests 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 and HART™ CVE Tests are leading the way in the proteomics era of improving cardiac medical care. 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, 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.