Cardio Diagnostics’ AI-driven coronary heart disease (CHD) tests have taken another promising step in their evolution.

Cardio Diagnostics CDIO, a pioneer in artificial intelligence-powered precision cardiovascular medicine, has been assigned two dedicated Current Procedural Terminology (CPT) Proprietary Laboratory Analysis (PLA); 0440U for the company’s AI-driven CHD detection test, PrecisionCHD, and 0439U for the company’s AI-driven CHD event (heart attack) risk assessment test, Epi+Gen CHD.

The American Medical Association (AMA) has designated these two new CPT PLA codes – effective April 1, 2024 – marking a significant step toward payer billing and payment for the company’s groundbreaking tests. The designation will facilitate the broader adoption of PrecisionCHD, an integrated genetic-epigenetic clinical blood test to aid in the diagnosis of CHD, and Epi+Gen CHD for evaluating the likelihood of a patient experiencing a CHD event, mainly a heart attack, within the next three years.

Addressing a Mounting Concern

Every year, about 805,000 individuals in the United States suffer a heart attack, equating to one person experiencing a heart attack every 40 seconds. Heart disease is the leading cause of death for both men and women. According to the CDC, in 2021, heart disease claimed the lives of over 695,000 Americans – amounting to one in every five deaths.

The most prevalent type of heart disease and the primary cause of heart attacks, CHD was responsible for over 375,000 deaths in 2021, and CHD-related medical costs are estimated to be approximately $239.9 billion, according to a CDC heart disease fact sheet.

In response to this escalating concern, Cardio Diagnostics reports that PrecisionCHD is the first integrated genetic-epigenetic test for the detection of CHD. The PrecisionCHD test has the capability to aid in the diagnosis of CHD and provide individualized insights to help prevent a heart attack and enhance outcomes.

With the introduction of PrecisionCHD, clinicians are equipped with a potent, scalable, and non-invasive alternative in the form of a blood-based test employing artificial intelligence, personalized genetic and epigenetic information, to sensitively detect the presence of CHD.

Identifying patients with CHD and intervening before a heart attack occurs is crucial in reducing the unprecedented economic and health burden associated with CHD. The lack of readily accessible and cost-effective diagnostic solutions for CHD has previously posed a challenge, resulting in delayed diagnosis and care, particularly among underserved and minority populations.

Enhancing accessibility, the PrecisionCHD test only requires a simple blood draw and can be administered remotely, enabling scalability without the need for specialized infrastructure. This allows for more timely intervention and management.

“Receiving a dedicated CPT PLA code for PrecisionCHD is a critical milestone in our commercialization strategy,” stated 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.”

While PrecisionCHD aids in diagnosing CHD, Cardio Diagnostics’ Epi+Gen CHD assesses an individual’s genetic and epigenetics to predict their risk for a heart attack or sudden cardiac death associated with CHD. By leveraging the powerful personalized insights driven by the company’s groundbreaking epigenetic-genetic technology, the company can provide patient-specific epigenetic and genetic drivers of CHD to guide preventive care, potentially saving lives.

In peer-reviewed studies, Epi+Gen CHD outperformed standard lipid-based risk calculators in terms of cost-effectiveness and sensitivity for assessing heart attack risk. In a validation study conducted with Intermountain Healthcare, Epi+Gen CHD was shown to be, on average, about twice as sensitive in detecting risk for a CHD event in women compared to lipid-based calculators.

For employers, the financial burden of heart attacks includes direct costs related to diagnosing, managing, and treating heart disease. Indirect costs comprise lost productivity due to employee absenteeism and short-term disability, which can indirectly cost employers about $1,119 per month for up to three years.

Cardio Diagnostics’ technology can assist employers in enhancing their benefits offerings by combining the ability to provide employees with the advanced Epi+Gen CHD heart attack risk test with aggregated risk data. Cardio Diagnostics’ Employer Risk Intelligence platform equips employers and brokers with a singular, cardiovascular employee population health intelligence supported by a clinical test and layered insights, completed in a compliant manner.

Consequently, Epi+Gen CHD’s new reimbursement code could result in broader access to technology that fosters a healthier workforce and substantial savings in healthcare costs related to heart disease.

“Cardio Diagnostics is committed to driving widespread adoption of our solutions, and obtaining a reimbursement code for Epi+Gen CHD is a critical milestone in our commercialization strategy and for gaining reimbursement from federal and private payers,” expressed Dogan.

Cardio Diagnostics continues to lead the way in precision cardiovascular medicine, harnessing the power of AI and epigenetics to prevent heart attacks. The company is dedicated to making heart disease risk assessment, detection, and management more accessible, believing that personalized and precise diagnostics are pivotal in combating the leading cause of death in the United States.

Featured photo by National Cancer Institute on Unsplash.

This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice.