The Cardiovascular Event Risk Test (CERT) from Zora Biosciences, Espoo, Finland, identifies the risk of heart attack more accurately than LDL cholesterol or measurements based on LDL cholesterol. CERT and its latest version, CERT2, are blood tests that measure ceramide lipids by mass spectrometry, enabling patient stratification into risk groups more accurately than current lipid tests.

Plasma ceramides represent the next generation of clinical predictors for adverse cardiovascular events resulting from unstable atherosclerotic plaques. Ceramides are bioactive lipids that play a central role in cell membrane integrity, cellular stress response, inflammation, and cell death.

Cardiovascular diseases are the leading cause of death worldwide. In 2015, coronary heart disease affected 110 million people and resulted in 8.9 million deaths. The common belief is that coronary heart disease (CHD) patients are at an equally high risk for cardiovascular events such as heart attack.

But according to a new international study, there is substantial variability in the risk of future cardiovascular events among CHD patients.1 Moreover, the study showed that measurement of patients’ LDL cholesterol levels is unable to predict future cardiovascular events and fails to identify coronary heart disease patients at the highest risk levels.1

“It is common to assume that all CHD patients have an equivalent cardiovascular risk, but according to this study this seems not to be the case,” says Reijo Laaksonen, MD, FESC, chief medical officer at Zora Biosciences. “For instance, the 10-year cardiovascular death risk of a CHD patient may vary from 5% to over 20%.”

Current clinical markers are not effective for identifying high-risk patients. Laboratory tests such as CERT2 may offer an advantage over classical risk calculators such as LDL cholesterol in terms of their reliability, ease-of-use, and predictive power. CERT2 provides an efficient tool for focusing resources where most appropriate, namely, the highest risk CHD patients.

CERT is a blood sample test that measures the risk of cardiovascular events and the risk of type 2 diabetes. CERT has been extensively validated in more than 80,000 patient samples analyzed retrospectively and shown to be a much more reliable predictor of cardiovascular risk than other markers in use today. Branded as Hertta in Europe, CERT is available widely in Finland through private healthcare providers and select public sites, with all samples being analyzed by the Zora reference facility. Zora has collaborated with the Mayo Clinic to commercialize CERT as a laboratory-developed test in the United States.

For more information, visit Zora Biosciences.

Reference

  1. Hilvo M, Meikle PJ, Pedersen ER, et al. Developmentand validation of a ceramide- and phospholipid-based cardiovascular risk estimation score for coronary heart disease patients. Eur Heart J. Epub ahead of print, June 18, 2019; doi: 10.1093/eurheartj/ehz387.