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PrecisionCHD™

Coronary Heart Disease Detection and Management

What is PrecisionCHD™?

PrecisionCHD™ is a clinical blood test, available by prescription only, that aids in the diagnosis of coronary heart disease (CHD) and identifies the specific molecular drivers of CHD for each patient. It evaluates a targeted panel of six epigenetic and ten genetic biomarkers associated with CHD. By applying artificial intelligence, the test predicts with high sensitivity whether a signal associated with CHD is detected.

PrecisionCHD™ allows providers to treat each patient as a category of one through a precise, individualized assessment of CHD. Using the lens of AI, it uncovers the molecular underpinnings that may precede symptoms and measurable physical changes, helping overcome the limitations of current tools and informing personalized care.

With re-testing, the DNA methylation biomarkers of PrecisionCHD™ have been demonstrated to change in response to intervention. This test can detect both obstructive and non-obstructive disease in a non-invasive, radiation-free manner.

PrecisionCHD™
Rx Only   FSA/HSA Eligible

Test results include actionable insights on the impact of biomarkers on disease signal and associated pathways to help personalize care

Non-Invasive, No Radiation, No Fasting

Understanding the PrecisionCHD™ Clinical Report

Signal Not Detected

Signal Not Detected

Signal Detected

Signal Detected

The AI model was trained and validated to interpret the complex patterns and relationships between DNA methylation and single nucleotide polymorphisms to distinguish between individuals with and without a CHD diagnosis.

Signal Detected indicates the presence of methylation patterns previously observed in patients with a CHD diagnosis.

Signal Not Detected indicates that the patient's methylation patterns are consistent with patients who were not diagnosed with CHD.

The ordering provider will receive an Actionable Clinical Intelligence report that outlines the patient-specific molecular drivers of disease. These insights explain the "why" behind the result, enabling more personalized care and better-informed decisions for preventing and managing coronary heart disease.

PrecisionCHD™ Is Intended for Patients Who:

Rx Only   FSA/HSA Eligible

Are between 35 to 80 years old

Are between 35 to 80 years old

Are presenting to be evaluated for coronary heart disease

Are presenting to be evaluated for coronary heart disease

Have not had a bone marrow transplant

Have not had a bone marrow transplant

No Radiation  ●  No Fasting  ●  Compatible with Telemedicine

Reveal the Molecular Drivers of Coronary Heart Disease With PrecisionCHD™

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  1. Philibert, R., T. K. Dogan, S. Knight, F. Ahmad, S. Lau, G. Miles, K. U. Knowlton, and M. V. Dogan. "Validation of an Integrated Genetic–Epigenetic Test for the Assessment of Coronary Heart Disease." Journal of the American Heart Association 12 (2023): e030934. https://doi.org/10.1161/JAHA.123.030934

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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.