Epi+Gen CHD™: A NextGen test for improved three-year coronary heart disease risk assessment
Epi+Gen CHD™ takes a completely new approach to coronary heart disease risk assessment by combining DNA testing of genetic and epigenetic biomarkers with artificial intelligence-based analysis to generate personalized risk profiles for each patient. This evidence-based test is based on patent-pending and proprietary technologies.
NextGen Technology Allows Better Prevention of Coronary Heart Disease
Every 40 seconds
someone has a heart attack.
are killed by heart disease each year.
each year experience their first heart attack.
is the yearly cost of heart disease in healthcare and lost productivity.
Early risk screening can drastically reduce the chances of a life altering cardiac event
However, primary care clinicians must still rely on crude tools to understand which of their patients are at high risk. Current risk screening methods have several limitations:
Traditional tests require an in-person clinic visit. With primary care visits down especially due to COVID-19, many patients are cancelling their routine screening.
Current lipid-based tests have low sensitivity, especially for women.
Coronary calcium screening can expose patients to potentially harmful ionizing radiation.
Current tools use long-term (10-year) windows that do not capture near term risk.
In a survey by Cardio Diagnostics, 100% of practicing physicians agreed that there is a need for a better method for primary cardiovascular prevention screening.
Advantages of Epi+Gen CHD™
Flexible physician journey
The test can be ordered and interpreted remotely or in-person by a healthcare provider
Flexible patient journey
Patients can give their blood sample in the comfort and privacy of their home, or have it collected at the healthcare provider’s office
Evidence-based test shown to correctly identify >70% of events with no bias between men and women
Each test report is tailored to each patient’s unique biological risk
The test is performed in a high complexity CLIA certified lab
Epigenetic profiles can change with lifestyle changes and treatment, which may serve as a metric to measure the effect of changes of health behaviors on risk over time
It is a standalone test without need for patient self-report, assessment of vital signs, or input of lipid variables
The results of Epi+Gen CHD™ can be used with other tests to effectively guide heart disease prevention
No fasting or special preparation needed
This test does not expose potentially vulnerable patients to ionizing radiation
Three-year risk assessment, as opposed to the conventional 10-year assessment
Who is the test appropriate for?
The test was validated in patients over the age of 35 who did not have coronary heart disease (CHD). The test is useful for screening patients for risk of CHD, but not for other cardiac conditions such as arrhythmia, heart failure, or aneurysm.
What are the results from the Epi+Gen CHD™ test?
The current output from the test is the 3-year risk of symptomatic CHD characterized as low, intermediate, or high.
Who receives a copy of the results?
If the physician requests the test, the results are sent directly to the physician for disclosure to the patient. If a patient initiates the request for the test through our web portal and requests a telemedicine visit, a copy of the results is released to them by their telemedicine physician.
What is the turnaround time?
Currently, the test results from our CLIA certified laboratory are returned approximately 7-10 business days after receipt of the sample in the lab.
How does the test work?
The test (patent pending) measures DNA methylation status at 3 loci and genotype at 5 loci. Then, an artificial intelligence guided algorithm interprets the results of the DNA methylation contextually with respect to the genetic variation. This approach allows us to interpret epigenetic signatures that would otherwise be confounded by background genetic variation. Similar approaches are being used by other epigenetically based tests such as Cologuard®.
What are the advantages of the test as compared to standard lipid profile-based approaches?
The test is approximately twice as sensitive for CHD related events over the 3-year risk window as conventional risk calculators (Framingham Risk Score and ASCVD Risk Calculator). In addition, the content available on our web portal provides guidance for addressing other risk factors for myocardial infarction such as serum cholesterol levels.
Can I preorder an inventory of tests for my office?
Yes. To do so, please email customer service at [email protected] and tell them whether you desire the finger lancet or venipuncture based collection kits. The collection tubes from both kits are shelf stable.
Where can I go to learn more about the test?
The scientific premise for the test was described in “Integrated genetic and epigenetic prediction of coronary heart disease in the Framingham Heart Study”. The description of the test validation was presented at the 2020 American Heart Association Meeting in Phoenix and the paper detailing the test is under review at a leading journal. In addition, the company regularly hosts webinars discussing the technology. If you would like our medical director to contact you directly, please email the request to [email protected] along with your contact information.
Can I still order a traditional lipid profile panel?
Yes. Our results can easily be supplemented with the results from the Framingham Risk Score and the ASCVD Pooled Cohort Equation risk estimators. Because Epi+Gen CHD™ is much more sensitive to the onset of CHD, it is quite possible our test will indicate increased risk in those individuals thought to be at low risk according to these conventional risk calculators, or occasionally, vice versa. In those cases with discrepant results, we suggest erroring on the side of caution since the onset of CHD can be fatal.
What do I do if the test comes back with an elevated risk score?
We highly recommend following the American Heart Association Guidelines which include considering secondary testing, the encouragement of lifestyle changes, and use of statins.
When should the test be repeated?
Within three years. The updated methylation values may show the change in incident CHD risk since the prior evaluation.