AMPEL develops a blood test for cardiovascular disease

Cardiovascular disease burden

It is important to explore cardiovascular disease's global and domestic impacts to understand the role of a test like this.

The WHO defines cardiovascular diseases as a category of disorders that can impact the heart and blood vessels. This class of diseases includes coronary heart disease, cerebrovascular disease, peripheral arterial disease, rheumatic heart disease, congenital heart disease, deep vein thrombosis, and pulmonary embolism.

Left untreated, cardiovascular disease can cause heart attack, heart failure, cardiomyopathy, stroke, abnormal heart rhythms, cardiogenic shock, cardiac arrest, heart valve disease, pulmonary hypertension and liver or kidney damage.

Globally, cardiovascular diseases are the leading cause of death, contributing to 32% of all global deaths in 2019.

In the United States, cardiovascular disease is also the leading cause of death, contributing to approximately 20% of fatalities domestically. According to the CDC, in 2022, 702,880 people in the U.S. died of heart disease. The organization also estimates that one person dies from cardiovascular disease every 33 seconds.

This class of disorders yielded an economic burden of $253.2 billion from 2019 to 2020.

Despite the physical and economic challenges associated with cardiovascular disease, there are ways to manage the condition and prevent complications, including lifestyle changes, medications, surgical interventions, medical procedures, and cardiac rehab programs.

However, getting the care necessary to manage or prevent it relies on getting a disease diagnosis before the condition has progressed to fatal severities.

Grammer explained that this is where AMPEL's CardioGENE blood test could be a minimally invasive tool to predict cardiovascular disease risk, detect inflammatory biomarkers that could indicate cardiovascular disease, and identify potential treatment avenues.

Traditional screening for cardiovascular disease

Diagnosing cardiovascular disease is a multipronged approach that involves a physical exam, symptom assessments, personal and family history analysis, and diagnostic testing.

"There are several aspects that cardiologists use to monitor individuals. One is family history, and you get referred to a cardiologist if you have elevated lipids and symptoms, and they do imaging," Grammer stated.

Patients at risk for cardiovascular disease might also undergo traditional serologic testing to detect inflammation that indicates cardiovascular disease. Traditional serologic testing might include erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) tests. However, both tools are relatively old tests that might not detect inflammation for months after it begins.

ESR tests detect how quickly red blood cells drop in a test tube and provide a measurement in millimeters per hour. A higher measurement often indicates inflammation. On the other hand, CRP detects protein levels that are produced in the liver as a response to inflammation.

Using these factors to monitor cardiovascular disease means certain patients might fall through the cracks. First, it can take a long time for inflammation to be detected by the standard-of-care serological tests. Additionally, some patients might be at risk of cardiovascular disease but not exhibit the typical symptoms or risk factors, such as a high BMI or a history of smoking.

"A subset of individuals in the United States have cardiovascular events but a normal BMI. They don't have any of the risk factors like smoking; their lipids are normal, or they have high lipids and have gotten them down with traditional medications like statins," she added.

CardioGENE Blood test

Grammer explained that AMPEL's CardioGene blood test can detect and measure biomarkers for inflammation.

"The CardioGENE blood test in development measures both genetics and RNA expression genomics," Grammer shared. "In every cell of the body, there are roughly 20,000 genes that can be off or on at any moment, and our bodies are like looking at the lights on stage at a rock concert or theater. Our symptoms are the effect. AMPEL made the tools to go into every cell and know what switches are on and off so that we can give information about whether there's inflammation and the druggable targets."

"A big difference in the AMPEL CardioGENE blood test that is in development is that it could be used early in life to predict if somebody has a risk, and then if they do, to monitor them. When the test flips to inflammation-positive, it's nice to know that," Grammer explained, implying that providers could effectively use this data as actionable insight into their patient's health that can guide treatment plans.

"This unlocks the potential for CardioGENE blood tests to be a monitoring test that could be used annually, hopefully at a very young age. It'd be great if everybody started getting the test annually when they're in college so that everybody has a baseline. Then, as we all know, as we get older and life goes on, we all get inflammation for many different reasons. So, the test would flag inflammation and identify abnormalities."

The benefit of a test like this is that it can be tacked on to annual testing protocols, decreasing the need for additional testing and removing a barrier that might prevent patients from getting screened.

Veronica Salib has covered news related to the pharmaceutical and life sciences industry since 2022.