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Written by: Rob Philibert MD PhD (Chief Medical Officer)

Women’s National Health Month

White Coat Syndrome is real. Many, if not most, adults have considerable anxiety about seeing their physicians. One of the principal reasons for that low level of dread is that very often the visit entails a blood draw that requires overnight fasting. This is particularly true for those at risk for cardiovascular disease because the standard methods for screening for disease and monitoring the success of treatment require an overnight fast and several tubes of blood.

Imagine if there was a method that would not require fasting and would require only a few droplets of blood or better still, a little bit of saliva. Fortunately, thanks to epigenetics, such a method is not only on the way, but part of it is already available.

How do we assess and monitor risk now for heart disease? Current methods for assessing risk and monitoring response to treatment require assessments of four lipid variables and at least a baseline assessment for diabetes. Specifically, your clinician will need to check:

  • Low Density Lipoproteins (LDL)
  • High Density Lipoproteins (HDL)
  • Triglycerides
  • Total Cholesterol
  • Hemoglobin A1c

Based on those values and the answers to your questions, a provider can use a standard formula, referred to as the Pooled Cohort Equation (PCE), to estimate your risk for heart disease.

Then, if you are at risk or receiving preventive statin treatment, the provider will recheck each of those labs periodically to ensure that the medications are working and that the statin treatment is not adversely affecting your risk for diabetes. This is important because some types of medications used to treat high LDL levels can paradoxically increase your risk for diabetes, which itself is associated with heart disease.

This method also means a lot of needle pokes and a lot of fasting for the average patient. What is worse, particularly for women, it doesn’t work very well. Real world studies of the use of the PCE have demonstrated that the test fails to predict the majority of coronary heart disease events and is biased against women.

Fortunately, thanks to advances in epigenetic technologies fueled through National Institutes of Health sponsored research, Cardio Diagnostics Inc has introduced the Epi+Gen CHD™ test. In work that was presented at the American Heart Association conference and now contained in a soon-to-be published manuscript in a leading epigenetics journal, researchers from Cardio Diagnostics in collaboration with Intermountain Healthcare demonstrated in a head to head comparison that the Epi+Gen CHD™ test outperformed the PCE in predicting risk for coronary heart disease (CHD).

The difference for predicting need for treatment in women was particularly more telling; Epi+Gen CHD™ test was 40% more sensitive in predicting future risk.

By itself, that should be more than enough great news-particularly for women. However, more recently, researchers from the University of Iowa and Cardio Diagnostics have shown the potential for epigenetics to monitor the response to treatment.

How does this work? For many years, scientists have known that as you age or become ill, your “epigenetic signature” changes. In some circumstances, this is referred to as epigenetic aging. In the case of Epi+Gen CHD™, Cardio Diagnostics has harvested this information to provide a state-of-the-art test for clinical risk assessment. But until recently, it has not been clear whether the changes in risk for heart disease provided by successful prevention therapy would be mirrored by changes in a patient’s cardiac specific epigenetic signature.

The results of the study suggest the days of poking your arm to get lipid levels to monitor your response to prevention therapy are numbered. Specifically, the team showed that successful treatment for smoking, a major risk factor for CHD, was associated with changes in the CHD associated signatures within 3 months.

Most promisingly, the changes were most marked in the portion of the epigenetic signature that maps to genes that are also implicated in other smoking associated diseases. This is important because it suggests the potential for cost effective personalized prevention therapy. As we all know, predicting who will respond to a drug in a clinical setting is difficult. But imagine if it were possible to measure the effects of a drug like a statin not just on serum LDL levels, but on all of the most critical dimensions that affect your risk for a heart attack. This is the promise of the new findings and the potential for epigenetic monitoring of heart disease prevention.

May is Women’s National Health Month. May I suggest that you encourage the women around you to take the critical steps, such as getting the COVID19 vaccine and health prevention screening, so that every May can be a reminder of the progress that we are making in creating healthier lives for us all? As part of that process, please stop by the Cardio Diagnostics Inc website to learn about this powerful new epigenetic approach. The life you save just might be your own.


  1. Goff DC, Lloyd-Jones DM, Bennett G, Coady S, D’Agostino RB, Gibbons R, Greenland P, Lackland DT, Levy D, O’Donnell CJ et al: 2013 ACC/AHA guideline on the assessment of cardiovascular risk. Circulation 2014, 129(25_suppl_2):S49-S73.
  2. Rha S-W, Choi BG, Seo HS, Park S-H, Park JY, Chen K-Y, Park Y, Choi SY, Shim M-S, Kim JB et al: Impact of Statin Use on Development of New-Onset Diabetes Mellitus in Asian Population. The American Journal of Cardiology 2016, 117(3):382-387.
  3. Dogan M, Philibert R: Abstract P416: An Externally Validated and Highly Sensitive Artificial Intelligence-driven Integrated Genetic-epigenetic DNA Test for Incident Coronary Heart Disease Prediction. Circulation 2020, 141(Suppl_1):AP416-AP416.
  4. Philibert W, Andersen AM, Hoffman EA, Philibert R, Dogan M: The Reversion of DNA Methylation at Coronary Heart Disease Risk Loci in Response to Prevention Therapy. Processes 2021, 9(4):699.