- For decades, cardiovascular risk assessment has centered on a checklist of factors never designed to capture the full biological picture of how heart disease develops.
- What makes CHD numbers particularly troubling is that so much of this is preventable.
- Cardio Diagnostics has developed clinical tests rooted in epigenetics and genetics fields that examine how genes are expressed and regulated at the molecular level.
Coronary heart disease (“CHD”) remains the leading cause of death in the United States, but the tools doctors have long relied on to detect it early are proving less reliable than many patients assume. Cardio Diagnostics Holdings (NASDAQ: CDIO) reports that approximately 50% of individuals with coronary heart disease do not present with traditional risk factors and conventional risk calculators have an average sensitivity of 39%. In practical terms, that means that many who “look healthy” go on to have CHD and preventable cardiac events such as a heart attack.
For decades, cardiovascular risk assessment has centered on a checklist. Healthcare providers ask about cholesterol levels, blood pressure, smoking history, diabetes status, family history and weight. While these factors matter and are useful pieces of the puzzle, they were never designed to capture the full biological picture of how heart disease develops, and the data increasingly shows the gaps this leaves behind. Coronary heart disease is the most common form of cardiovascular disease (“CVD”) and often develops without symptoms, with a heart attack frequently serving as the first indication of disease. For many patients, by the time a traditional risk factor shows up, the disease may already be well underway.
The scale of the problem is significant. In the United States, one in 20 adults over the age of 20 lives with CHD, and it is the second leading cause of hospitalization, adding approximately $13,000 in annual healthcare costs per patient. The human toll is even starker. Heart attacks occur approximately every 40 seconds in the U.S., with more than 800,000 events annually, and one in five occurring without warning. There is also a lesser-known subset of the disease that adds further complexity. An additional three to four million Americans are affected by ischemia with no obstructive coronary arteries (“INOCA”), a subset of CHD.
What makes these numbers particularly troubling is that so much of this is preventable. An estimated 80% of cardiovascular disease is preventable through early detection and proactive management, yet the tools used to identify who needs that early intervention are missing more cases than they catch. A risk calculator with an average sensitivity of 39% means that for every 100 people who will experience a CHD event, on average, 39 of them would be flagged. Many patients walk out of a routine checkup with a clean bill of health, even as the disease quietly progresses.
This is the gap that Cardio Diagnostics is focusing on addressing. Rather than relying solely on the conventional risk factor checklist, the company has developed clinical tests rooted in genetics, the DNA blueprint, and epigenetics, the field that examines how genes are expressed and regulated at the molecular level, often in response to lifestyle, environment and underlying disease processes long before signs and symptoms may appear.
The company’s flagship offering, Epi+Gen CHD, is a blood-based test that assesses a patient’s three-year risk of experiencing a coronary heart disease event, including a heart attack, by analyzing a targeted panel of three epigenetic and five genetic biomarkers. Because these biomarkers can reflect biological changes happening regardless of the shifts in traditional markers, the test is designed to identify risk in people who may otherwise be classified as lower risk using standard tools.
The company also offers PrecisionCHD, which is also a clinical blood test designed to aid in the diagnosis of CHD. This solution analyzes a targeted panel of six epigenetic and 10 genetic biomarkers that are closely associated with CHD. Using artificial intelligence, the test predicts CHD signal with high sensitivity, supporting management of stable ischemic heart disease.
These tests are not a wholesale replacement for existing cardiology practice but rather an attempt to fill a documented and substantial blind spot. Traditional risk factors remain clinically relevant and continue to play a role in patient evaluation. What molecular biomarker testing adds is a second lens, one that can pick up signals the first lens was never built to detect.
For a disease that often gives no warning before a heart attack occurs, any tool that shifts the odds toward earlier detection carries meaningful weight. With more than 800,000 CHD events annually, and one in five heart attacks occurring without warning, and with the majority of cardiovascular disease considered preventable when caught early, the cost of missed detection is measured not just in healthcare dollars but in lives.
Cardio Diagnostics is positioning its epigenetics-based testing as part of the answer to that gap, offering physicians and patients a way to see risk that conventional tools have consistently struggled to capture. As the data on traditional risk calculator performance continues to circulate among clinicians and researchers, the case for incorporating molecular diagnostics into routine cardiovascular testing may continue to build.
For more information, visit www.CDIO.ai.
NOTE TO INVESTORS: The latest news and updates relating to CDIO are available in the company’s newsroom at https://ibn.fm/CDIO
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