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2026 Cardio Diagnostics, Inc.

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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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