Cardio Diagnostics Holdings, Inc. announced the publication of results from a budget impact modeling study for PrecisionCHD??, the Company's AI-powered multiomic coronary heart disease detection test. The peer-reviewed study "The Use of Precision Epigenetic Methods for the Diagnosis and Care of Stable Coronary Heart Disease Reduces Healthcare Costs" published in Advances in Therapy, reported that the use of PrecisionCHD can significantly reduce the cost of secondary prevention for stable coronary heart disease (CHD) by up to $113.6 million per year for a typical health insurance plan with one million members. PrecisionCHD is an AI-powered multiomic DNA test using epigenetic and genetic biomarkers to aid in the detection of stable CHD.

This blood-based test evaluates six DNA methylation and ten genetic biomarkers and uses a proprietary machine learning model to interpret the genetically contextual methylation signals from these biomarkers. The sensitivity and specificity of this test are 79% and 76%, respectively, with the clinical validation study in collaboration with Intermountain Healthcare and University of Iowa Hospitals and Clinics being recently published in the Journal of American Heart Association. The PrecisionCHD budget impact model was designed to evaluate the cost savings associated with using PrecisionCHD as the primary method of initial CHD assessment in place of current commonly used tests such as exercise electrocardiograms, coronary computed tomography angiography (CCTA), and angiograms. The model considered factors such as the number of tests performed, the cost of each test, and the impact of test results on treatment decisions.

The results suggest that using PrecisionCHD could lead to significant cost savings for payers, with an estimated $113.6 million saved per year for a plan with one million members. These savings are primarily driven by the lower cost of PrecisionCHD compared to traditional tests and the reduced need for additional testing. The model also found that the cost savings were not sensitive to patient demographics, or insurance plan design, with similar results being observed for plans that exclude Medicare enrollees, only include Medicare enrollees (Part B or Medicare Advantage), offer large co-insurance rates, and offer larger co-pays.

Heart disease remains the leading cause of death among Americans and one of the largest cost centers for payers. If the barriers to obtaining early cardiovascular care persists, the prevalence and costs associated with heart disease are only likely to increase. Currently, exercise electrocardiogram, CCTA and single photon emission computed tomography (SPECT) are some of the initial tests used to diagnose CHD.

These tests are resource intensive, and require expensive infrastructure and specialized personnel, creating inherent barriers to broader adoption especially in rural America. The continued reliance on these tests as the initial testing mode for CHD diagnosis could mean that more Americans are receiving earlier testing and care, potentially leading to higher costs for payers. Some of the current tests also have risks associated with being exposed to radiation and contrast dyes that could affect the health of the patient long term and the cost incurred by payers.

In contrast, PrecisionCHD is a blood-based test that could serve as a more cost efficient, highly scalable, and less resource intensive alternative for initial CHD detection testing. Its highly sensitive and specific performance minimizes the likelihood of false positives and negatives, potentially decreasing the need for costly follow up tests and procedures. PrecisionCHD can be implemented fully virtually via telemedicine and at-home blood sample collection, can be deployed in community settings via a mobile health clinic or in a more traditional provider setting.

This multimodal delivery approach is a win-win with broader access for patients and potential additional cost savings for payers with earlier detection and management of CHD. Furthermore, PrecisionCHD not only undercuts the expenses associated with conventional tests like CCTA and angiograms but also avoids the risks related to radiation and contrast dyes found in many imaging procedures by providing a cost-effective alternative for initial CHD diagnosis. This reduces potential costs tied to managing side effects.

Health plans increasingly prioritize precision medicine solutions to enhance patient outcomes and optimize cost-efficiency, reflecting an industry-wide transition from personalized to precision medicine. This evolution is underpinned by integrating genomic, clinical, and socio-economic data, enabling healthcare providers to customize treatment approaches and advance therapeutic innovation. Similarly, provider-led health plans, face the same challenges in optimizing patient care while reducing unnecessary medical spend.

PrecisionCHD stands out as an instrumental resource for health insurers and healthcare providers aiming to streamline the management and financial burden of CHD. As health systems increasingly adopt value-based care (VBC) models, the focus intensifies on achieving superior patient outcomes and improved population health while maintaining cost-effectiveness. Throughout 2023, the expansion and refinement of VBC models have underscored a concerted effort among healthcare providers, payers, and policymakers to enhance patient care and manage expenses effectively.

This strategic alignment with VBC frameworks highlights the significant role of tools like PrecisionCHD. These tools support targeted, data-driven decisions in CHD treatment and management, potentially revolutionizing approaches to healthcare delivery and cost management.