Obtaining a CPT PLA code marks a key milestone in securing reimbursement from federal and private payers for, and expanding access to the innovative PrecisionCHD test powered by AI and epigenetics

Cardio Diagnostics Holdings, Inc. (Nasdaq: CDIO), an AI-driven precision cardiovascular medicine company, today announced that the American Medical Association (AMA) has assigned a dedicated Current Procedural Terminology (CPT^®) Proprietary Laboratory Analysis (PLA), 0440U, for the company’s AI-driven coronary heart disease (CHD) detection test, PrecisionCHD. Receipt of this new CPT PLA code, which will be effective on April 1, 2024, is a significant step toward payer billing and payment, facilitating broader adoption of the first and only integrated genetic-epigenetic diagnostic blood test for CHD.

Transforming CHD Diagnosis: The Clinical and Economic Benefits of PrecisionCHD

CHD, which is the most common type of heart disease and the major cause of heart attacks, was responsible for over 375,000 deaths in 2021 and the medical costs associated with CHD are projected to reach about $215 billion by 2035. The PrecisionCHD test, which evaluates a patient’s unique genetic and epigenetic biomarkers and interprets them using AI, aims to aid in the diagnosis of CHD and provide personalized insights to help prevent a costly heart attack and improve outcomes.

Identifying those with CHD and intervening prior to a heart attack occurring are essential to reducing the unprecedented economic and health burden associated with CHD. However, the lack of readily accessible, scalable and cost-effective diagnostic solutions for CHD poses a significant challenge, and could lead to delayed diagnosis and care, particularly among underserved and minority populations. The PrecisionCHD test only requires a simple blood draw, can be deployed remotely, and be scaled without the need for specialized infrastructure to enable more timely intervention and management.

“Cardio Diagnostics is committed to ensuring that our solutions are widely accessible and receiving a dedicated CPT PLA code for PrecisionCHD is a critical milestone in our commercialization strategy,” said Meesha Dogan, Ph.D., CEO and Co-Founder of Cardio Diagnostics. “With PrecisionCHD, we believe that expanding equitable access to CHD diagnostics and improving patient health outcomes while reducing healthcare expenditure is possible.”

Transforming Care Delivery with PrecisionCHD

With the potential to prevent costly heart attacks and improve patient outcomes, PrecisionCHD is poised to play a significant role in reducing healthcare expenditures. By focusing on personalized insights and care along with earlier intervention even in locations that lack specialty cardiology resources, such as those in rural settings, PrecisionCHD supports the value-based care objective of delivering high-quality, timely care at a lower cost, benefiting patients, providers, and the healthcare system.

A Health Plan’s Population Health Initiative Can be Accelerated by PrecisionCHD

PrecisionCHD introduces a groundbreaking approach to CHD detection, which creates a new category of scalable and personalized cardiovascular diagnostic tools. This blood test offers innovative opportunities for health plans that need to implement, alongside their provider partners, widespread and actionable CHD detection and member risk stratification programs, leading to better care management and patient outcomes along with improved cost management. This potential impact on population health can be as significant as the technology itself.

PrecisionCHD Recognized for Innovation

The study outlining the development and validation of the PrecisionCHD test in collaboration with Intermountain Healthcare and University of Iowa Hospitals and Clinics, was recently published in the Journal of the American Heart Association, an official journal of the American Heart Association. PrecisionCHD was also included in the recent Innovative Technology contract awarded to Cardio Diagnostics by Vizient, Inc., the nation’s largest provider-driven healthcare performance improvement company whose customer base encompasses over 60% of hospitals and 97% of academic medical centers in the United States.

About Cardio Diagnostics

Cardio Diagnostics is an artificial intelligence-powered precision cardiovascular medicine company that makes cardiovascular disease prevention, detection, and management more accessible, personalized, and precise. The Company was formed to further develop and commercialize clinical tests by leveraging a proprietary Artificial Intelligence (AI)-driven Integrated Genetic-Epigenetic Engine (“Core Technology”) for cardiovascular disease to become one of the leading medical technology companies for improving prevention, detection, and treatment of cardiovascular disease. For more information, please visit www.cardiodiagnosticsinc.com.

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