Core Viewpoint - Prevencio's innovative AI-based blood test HART CADhs has received FDA breakthrough device designation, promising to enhance early diagnosis and intervention for obstructive coronary artery disease [2][3]. Group 1: Product Overview - HART CADhs is the only AI-based multi-protein blood test for cardiovascular assessment, designed to identify the presence of obstructive coronary artery disease through a simple blood sample [8][10]. - The test utilizes advanced AI algorithms to analyze multiple cardiac biomarkers, achieving an accuracy rate of 86% [10]. - It assesses three proteins: high-sensitivity troponin, adiponectin, and kidney injury molecule-1, along with clinical parameters like age, gender, and history of invasive cardiac interventions [10]. Group 2: Clinical Significance - Obstructive coronary artery disease is the most common type of coronary heart disease, often leading to severe outcomes like heart attacks and sudden death [4][7]. - Current diagnostic methods have limitations in accuracy and accessibility, particularly in areas lacking cardiac specialists [7][12]. - HART CADhs addresses these challenges by providing a non-invasive, rapid, and AI-driven diagnostic tool, which is crucial for improving early diagnosis and intervention [8][12]. Group 3: Future Prospects - Prevencio plans to transition HART CADhs from a laboratory-developed test to an FDA-approved in vitro diagnostic product, potentially reducing report turnaround time to one hour [12]. - The company aims to expand the use of HART CADhs into emergency care settings, enhancing early and accurate diagnosis for a broader patient population [13][14]. Group 4: Company Background - Prevencio, headquartered in Washington, is a leading AI medical blood testing company focused on early diagnosis and precision medicine for major diseases, including cardiovascular conditions [14]. - The company has developed seven blood testing products based on its HART platform, with significant research published in reputable journals [14].