Multinational Patient Study Demonstrates Prevencio’s AI-driven HART Blood Test Highly Accurate for Risk of Heart Attack, Stroke, and Cardiac Death

Novel multi-protein blood test data on more than 1,500 patients presented at 2021 American College of Cardiology Scientific Sessions

KIRKLAND, Wash.--(BUSINESS WIRE)-- Prevencio, Inc. today announces the presentation of multinational patient data demonstrating its Artificial Intelligence (AI)-driven blood test is more accurate than commonly-used risk factors, genetic tests, and coronary artery calcium scores in determining whether a person will have a heart attack or major cardiac event within the next year. Cardiologists believe the validation data, presented at this week’s American College of Cardiology (ACC) Scientific Sessions, could lead to significantly improved risk classification of patients, allowing for more aggressive therapy in higher-risk patients and avoiding expensive or invasive treatment in lower-risk patients.

Cardiologists from Massachusetts General Hospital, Inova Heart and Vascular Institute, and University Heart Center of Hamburg, Germany, collaborated to test more than 1,500 subjects to predict a patient’s one-year risk of having a heart attack, stroke, or cardiovascular death. When the test score was divided into low-risk and high-risk categories, the test predicted with 98% 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 patients with 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, 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 cardiac event, Prevencio has recently launched 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 honored to work with these esteemed teams of dedicated cardiologists 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.

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. By 2030, more than 40% of the U.S. adult population is projected to have cardiovascular disease.

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

HART test results have been peer-reviewed published 22 times, including at leading cardiovascular meetings—(European Society of Cardiology Congress – 2016, 2018; American College of Cardiology Scientific Sessions – 2017, 2018, 2019, 2020, 2021; American Heart Association Scientific Sessions – 2017, 2018, 2019; American Diabetes Association Scientific Sessions – 2018, 2019; and Pediatric Academic Societies International Sessions – 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).

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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