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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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Resources

Our latest insights on cardiovascular care strategy for patients, providers, employers, and benefit teams.

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2027 Employee Health and Wellness Program Trends

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2027 Employee Health and Wellness Program Trends

Employers are increasingly focusing on employee well-being to attract and retain top talent. Dive into the top five trends shaping employee wellness.

The State of Rural Hospitals and Cardiovascular Care

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The State of Rural Hospitals and Cardiovascular Care

The USDA has estimated that 146 U.S. rural hospitals closed or stopped providing inpatient care between 2005 to 2023. Can a new model of care help?

Value-Based Care Technology: AI for Heart Disease Care

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Value-Based Care Technology: AI for Heart Disease Care

When paired with advanced technology and AI, value-based care can transform healthcare models at scale. Read more.

Heart Problems and Summer Heat: Are You at Risk? 

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Heart Problems and Summer Heat: Are You at Risk? 

Summer heat can place a significant burden on your heart. Are you at risk? Read our article to learn who’s most at risk and how to keep your heart saf…

Understanding the Physiological Connection Between Stress and Heart Disease

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Understanding the Physiological Connection Between Stress and Heart Disease

Learn how chronic stress affects heart health and how precision medicine can help identify cardiovascular risk earlier for more personalized preventio…

Top 5 Misconceptions of Heart Disease

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Top 5 Misconceptions of Heart Disease

Heart disease is the leading cause of death in the United States, yet several myths persist. Demystify the common misconceptions.

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