Prevencio and Seattle Children’s Research Institute Present Highly Accurate, AI-driven HART KD Data on First Blood Test for Kawasaki Disease at Premiere International Kawasaki Disease Scientific Sessions  

HART KD test uses proteins commercially available on widely-used lab instrumentation to facilitate expeditious development and commercialization

KIRKLAND, Wash.--(BUSINESS WIRE)-- Prevencio, Inc. today announces presentation of highly accurate data on an Artificial Intelligence (AI)-driven blood test for Kawasaki disease (KD) at the International Kawasaki Disease Scientific Sessions in Japan. The novel test, HART KD, was jointly developed with Seattle Children’s Research Institute and leveraged Prevencio’s AI-driven HART platform and expertise in developing novel AI-driven blood tests.

Seattle Children’s owns exclusive rights to the intellectual property, which is exclusively licensed to Prevencio. For the first time, KD can be accurately diagnosed with easily measured proteins in children’s blood. A key differentiator is using an AI-driven algorithm, or weighting of each protein, which greatly enhances accuracy as compared to nonspecific, single protein tests. HART KD provides a long-needed, diagnostic blood test to distinguish KD from common infectious and inflammatory conditions.

“Kawasaki disease is the most common acquired heart disease in children and occurs mostly in children younger than 5 years old. Among the main presenting symptoms are persistent fever and rash. This makes diagnosis challenging as thousands of children with these symptoms present annually to U.S. emergency departments and pediatrician offices,” said Michael Portman, MD, director of pediatric cardiovascular research at Seattle Children’s and professor of pediatrics at the University of Washington School of Medicine. “Since COVID-19-associated Multisystem Inflammatory Syndrome in Children (MIS-C) and Kawasaki disease share similar presenting symptoms, timely and accurate diagnosis of Kawasaki disease is even more critical.”

Without early treatment, there is a 25%-30% risk of heart artery dilation and aneurysms (balloon-like bulges of heart vessels) that may ultimately result in heart attacks, congestive heart failure, sudden death, and need for lifelong therapy.

Portman added, “Prior to HART KD, there was no specific diagnostic test for Kawasaki disease. We are astounded with the robust 92% accuracy of HART KD and highly value our collaboration with Prevencio to address this critical, unmet medical need.”

Incidence rates of KD in the U.S. are 19 to 25 cases per 100,000 children under age 5, and it is rising. Predictive models estimate that by 2030, 1 in every 1,600 American adults will have been affected by the disease. Prevalence rates are even higher among children in Asia and are increasing. Japan has the highest incidence rate, with more than 16,000 new cases per year. One in every 60 boys and one in every 75 girls in Japan will develop KD during childhood.

Rhonda Rhyne, Prevencio’s Chief Executive Officer, added, “We are pleased to collaborate with Seattle Children’s Research Institute, one of the nation’s top pediatric research centers, and are grateful to expand use of our AI Hart platform to Kawasaki disease. We are highly encouraged that the proteins in HART KD are individually FDA-cleared and commercially available on widely-used lab instrumentation. This should enable expeditious development and a more reliable FDA-clearance path for our AI-driven algorithm test.”

Prevencio is in commercialization discussions with protein-measuring platform companies for partnerships and licensing to offer HART KD for children suspected of Kawasaki disease.

Prevencio recently launched for patient use its two lead tests, HART CVE (for one-year risk of heart attack, stroke, or cardiac death) and HART CADhs (for obstructive heart disease diagnosis). For additional information, visit Prevencio, Inc.

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 diagnosis and risk assessment 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 26 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; American Heart Association Scientific Sessions – 2017, 2018, 2019; 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).

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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