Precision Medicine Blood Test Predicts Heart Disease Before It Occurs

AMPEL BioSolutions (Charlottesville, VA, USA) has published a paper in the peer-reviewed journal Cell iScience that validates and expands upon the inflammatory and immune system abnormalities in the blood of individuals predisposed to heart disease, which the company first identified two years ago. By analyzing genes expressed in single cells isolated from atherosclerotic coronary artery plaques, the study revealed biomarkers that can be measured using AMPEL’s CardioGENE blood test. This innovative approach, which connects genetic predisposition to real-time molecular pathways targeted by specific drugs, has the potential to transform healthcare by enabling physicians to assess cardiovascular disease risk and select appropriate treatments. Notably, the publication shows that common genetic risk factors contributing to cardiovascular disease in non-autoimmune individuals are the same as those in patients with autoimmune inflammatory diseases such as lupus, psoriasis, Type 1 diabetes, rheumatoid arthritis, primary biliary cirrhosis, and celiac disease, all of whom face increased cardiovascular event risks.

AMPEL’s findings build on a cardiologist-led study published in The Lancet last year, which demonstrated that inflammation, as measured by standard tests like CRP or ESR, predicts cardiovascular risk in individuals even after lipid levels have been normalized with medication. This is the first time that cardiovascular genetic risk factors have been identified in immune and inflammatory system genes across autoimmune diseases, even in the absence of traditional risk factors like smoking, high cholesterol, or elevated blood pressure. AMPEL’s CardioGENE blood test is now poised for development as a decision-support biomarker tool. This development marks AMPEL's expansion into genetic testing, complementing its existing expertise in RNA analytics and explainable predictive AI. By identifying the relevant molecular pathways, CardioGENE will help healthcare providers prevent major cardiovascular events through targeted prophylactic treatments. Notably, FDA-approved drugs such as colchicine, along with biologics that target inflammatory cytokines and immune cells, are candidates for these preventive therapies.

“The CardioGENE blood test identifies inherited genetic markers in blood samples that drive pathways, which can be targeted by drugs,” said Dr. Amrie Grammer, AMPEL Co-Founder, President and Chief Scientific Officer. “We are confident that CardioGENE will make a difference in the lives of all Americans especially those with autoimmune inflammatory diseases who disproportionately suffer from the disease’s cardiovascular impacts.”

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