Cardiovascular disease has been the leading cause of death in this country for 100 years. About 695,000 people died of heart disease in the U.S. in 2021, according to the Centers for Disease Control and Prevention (CDC).
In addition to the tragedy of each of these deaths, heart disease is also an economic burden, costing $239.9 billing each year from 2018 to 2019, including healthcare services, medicines and lost productivity.
While cholesterol blood tests are a routine part of care to detect who has or is at risk of heart disease, those tests don’t identify those patients 100% of the time. As such, researchers have been working to establish new, better tests for who is at risk for cardiovascular disease, including tests for lipoprotein(a) [Lp(a)], apolipoprotein, and apolipoprotein B (apo B). These markers have shown potential in detecting cardiovascular risk in those who are not setting off alarm bells through more traditional tests.
“People understand and recognize in clinical guidelines that there are limitations with some of the traditional blood lipid measurements,” when it comes to detecting cardiovascular disease,” said Alycia Lyle, PhD, FAHA, lead research chemist at the CDC.
Lyle will be hosting a roundtable at ADLM 2024 to provide a brief overview of existing traditional lipid biomarker programs and will focus on the unique services offered by the CDC Clinical Standardization Program (CSP) at different levels of the standardization process.
She will also discuss the CDC’s Cardiovascular Disease Biomarker Standardization Programs (CVDSP) efforts to establish new programs for Lp(a), apolipoprotein, and apo B measurements, and provide updates on recent collaborative efforts to establish new analytical performance criteria. If these new biomarkers are going to be used in clinical care, there needs to be standardization so that they are providing consistent results that can help patients.
“Clinical guidelines continue to change and incorporate new biomarkers for cardiovascular disease, and it becomes increasingly important to ensure that those measurements are aligned, and to make sure that in doing so, we have continuity of care for patients,” said Lyle. “We are adding those markers to ensure they are standardized and all assays across the board say the same thing.”
She will also be presenting as yet unpublished research that shows that despite individuals typically having two different sizes of these biomarkers in circulation, that it doesn’t drive assay variability, as previously thought.
Lyle hopes that her round table can help update laboratory supervisors, directors and managers, along with medical technologists, pathologists and other laboratory professionals on what’s going on in this space, which is changing rapidly. “It’s important for people to understand that there are continuous changes that go on within the clinical chemistry space, and that our cardiovascular biomarkers programs,” she said, and that they are working to maintain existing accuracy and standardization of new ones. “We’re trying to keep up with guidelines so those measurements in a clinical setting are reliable.”
She also hopes that attendees will have “a better understanding of what we’re doing and the importance of standardization for patient care,” she said.
Jen A. Miller is a freelance journalist who lives in Audubon, New Jersey. +X: @byJenAMiller.