Massachusetts’s General Hospital Study Demonstrates Prevencio’s AI-driven HART CVE Blood Test Highly Accurate in Patients with Diabetes for Predicting Heart Attack, Stroke, and Cardiac Death Risk

KIRKLAND, Wash.--(BUSINESS WIRE)-- Prevencio, Inc. today announces the presentation of patient data demonstrating its Artificial Intelligence (AI)-driven HART CVE blood test is highly accurate in determining whether a person with diabetes will have a heart attack or major cardiac event within the next year. The data, presented at last week’s American College of Cardiology (ACC) Scientific Sessions, suggests the HART CVE blood test significantly improves risk classification of patients with diabetes, allowing for more aggressive therapy in higher-risk patients and avoiding expensive or invasive treatment in lower-risk patients.

Cardiologists from Massachusetts General Hospital tested 450 subjects to predict one-year risk of heart attack, stroke, or cardiovascular death in patients with diabetes. When the test score was divided into low-risk and high-risk categories, the test showed a highly accurate Hazard Ratio (HR) of 25, meaning that a high-risk patient with diabetes has 25 times the risk for a major cardiac event within one year as compared to low-risk patients without diabetes.

“This multiple protein, weighted risk test provides improved accuracy as compared to clinical risk factors and could be particularly useful for patients with diabetes who also have suspected or known stable and acute heart disease, for which there are very few prognostic risk models,” said James L. Januzzi, MD, a practicing cardiologist at Massachusetts General Hospital, Professor of Medicine at Harvard Medical School and Principal Investigator in development, validation, and ongoing testing of the HART CVE test. “In addition to leading to more appropriate care of patients with diabetes, 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.”

In addition to the HART CVE test for one-year risk of a major cardiac event, Prevencio offers a second multi-protein blood test, HART CADhs, for diagnosing obstruction of the heart arteries. HART CADhs was shown to be more accurate (86% AUC accuracy) than standard-of-care stress tests (52% AUC accuracy). HART CVE and HART CADhs tests are currently available to medical professionals for patient use. For additional information, visit Prevencio, Inc.

“Prevencio is grateful for our collaboration with Massachusetts General Hospital, and we look forward to ongoing improvement in patient care,” said Rhonda Rhyne, President and Chief Executive Officer of Prevencio. “Our mission is to provide clinicians with safer, more accurate, and more affordable ways to identify and treat the tens of millions of patients with diabetes and cardiac issues.”

Cardiovascular disease is the leading cause of death in the U.S. and globally. Additionally, diabetes was the seventh leading cause of death in the U.S. in 2017 and is believed to be underreported as a cause of death. Patients with diabetes have twice the rate of cardiovascular disease as compared to patients without diabetes. According to the American Diabetes Association, 34.2 million Americans or 10.5% of the population had diabetes in 2018, costing $327 billion in healthcare expenditures.

About Prevencio HART Tests:

Powered by AI, Prevencio is revolutionizing blood tests for cardiovascular disease and custom diagnostics. Employing this novel approach, the company has developed seven blood tests that significantly improve diagnoses for a variety of heart and blood vessel-related complications.

Our three lead tests include:

1. HART CVE^TM – 1-year risk of heart attack, stroke, or cardiac death
2. HART CADhs^TM – obstructive coronary artery disease diagnosis
3. HART KD^TM – Kawasaki disease diagnosis

HART test results have been peer-reviewed published 29 times, including at leading cardiovascular meetings—(European Society of Cardiology Congress – 2016, 2018, 2021; American College of Cardiology Scientific Sessions – 2017, 2018, 2019 (2), 2020, 2021, 2022; American Heart Association Scientific Sessions – 2017, 2018, 2019, 2021; American Diabetes Association Scientific Sessions – 2018, 2019; Pediatric Academic Societies International Sessions – 2021; International Spinal Cord Society Scientific Sessions –2021; ASTRO Scientific Sessions – 2021; International Kawasaki Disease Symposium – 2021) and in top-tier journals—(Journal of American College of Cardiology – Mar 2017; American Journal of Cardiology – July 2017; Clinical Cardiology – June 2018; Open Heart – November 2018, May 2019; Jan 2019; Biomarkers in Medicine – June 2020; Journal of American Heart Association – Aug 2020; European Journal of Preventive Cardiology – March 2022).

About Prevencio, Inc.:

Prevencio’s value proposition is “Preventing the Preventable” — That is, preventing unnecessary procedures, related side effects, and expense, as well as improving patient outcomes and clinical trials through more accurate blood tests for Cardiovascular Disease conditions. Prevencio utilizes Machine Learning (Artificial Intelligence) + Multi-Proteomic Biomarkers + Proprietary Algorithms to deliver cardiovascular diagnostic & prognostic tests that are significantly more accurate than standard-of-care stress tests. The company is headquartered in Kirkland, Washington. For additional information, visit Prevencio, Inc.

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, and size, the accuracy of which is necessarily subject to various uncertainties of development-stage companies. The Company does not undertake to update disclosures contained in this press release.

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