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The Cardio Diagnostics clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high-complexity clinical laboratory testing. The Epi+Gen CHD™ and PrecisionCHD™ tests were developed, and their performance characteristics were determined by Cardio Diagnostics. These tests should be ordered by a licensed healthcare provider, and test results should be interpreted by a healthcare provider in the context of medical history, clinical signs and symptoms, and other relevant clinical information. These tests are intended for clinical purposes and have not been cleared or approved by the U.S. Food and Drug Administration (FDA).

For the Epi+Gen CHD™ test, a lower risk result does not eliminate the possibility of a coronary heart disease event occurring or that coronary heart disease is present, and a higher risk result does not imply a diagnosis of coronary heart disease or that a coronary heart disease event will occur. For the PrecisionCHD™ test, a "Signal Detected" result is not a diagnosis of coronary heart disease, and a "Signal Not Detected" result does not eliminate the possibility that coronary heart disease is present or could occur in the future. False positive and false negative test results do occur. Rx only.

In addition to a federal CLIA license, the Cardio Diagnostics clinical laboratory holds active state clinical laboratory licenses in California, Maryland, Pennsylvania, and Rhode Island. The laboratory is not currently licensed to process patient samples originating from the state of New York.

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Precision Cardiovascular
Medicine with
Epigenetics and AI

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Delivering Precision Cardiovascular Medicine to
Patients, Providers, and Employers

Patients

Take the first step today toward better heart health.

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Providers

Advance prevention and detection of coronary heart disease with precision medicine insights.

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Employers

Protect your workforce and lower healthcare spend.

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Cardiovascular Disease

Our Solutions are Redefining Cardiovascular Disease Prevention and Detection

For clinical stakeholders, our tests deliver evidence-based insights derived from patients' epigenetic and genetic biomarkers. For non-clinical stakeholders, our population and biopharma platforms transform complex molecular data into meaningful, data-driven intelligence.

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Our Proprietary Technology Harnesses Epigenetics, Genetics, and AI to Transform Complex Data into Powerful Clinical and Population Health Solutions

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Educational Resources

Heart Disease is a Women’s Health Problem that Deserves More Attention

Article

Heart Disease is a Women’s Health Problem that Deserves More Attention

Heart disease is the leading cause of death for women, yet it remains under recognized, under diagnosed, and too often overlooked in conversations abo…

Mapping Heart Disease Biology with DNA Methylation

Article

Mapping Heart Disease Biology with DNA Methylation

How does DNA methylation affect heart disease? Methylation patterns can signal inflammation and vascular dysfunction, supporting earlier, more precise…

Precision Medicine Across the Cardiac Care Continuum

Article

Precision Medicine Across the Cardiac Care Continuum

Using conventional methods, patients with low risk for CHD sometimes present with acute events, while others thought to be at high risk may remain eve…

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