New diagnostic test, CERT, improves risk prediction over standard laboratory tests

June 26, 2019

A Finnish diagnostic company, Zora Biosciences Oy, has developed a diagnostic test, CERT (Cardiovascular Event Risk Test) that identifies the risk of heart attack more accurately than LDL-cholesterol or LDL-cholesterol based measurements, said the company in a news release. It says CERT, available in the U.S. from Mayo Clinic, enables patient stratification into risk groups more accurately than the currently used lipid tests and provides an enhanced tool for capturing the risk. 

CERT, and its latest version CERT2, is a blood test that measures ceramide lipids by mass spectrometry. 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.

Zora pointed to a new international study that shows that LDL-cholesterol is unable to predict future cardiovascular events and fails to identify those coronary heart disease patients who are at the highest risk and who would benefit most from additional attention and preventive action.

The research, a 10,000 coronary heart disease (CHD) patient study showing the prognostic performance of CERT  in comparison to standard laboratory measurements.is published in the European Heart Journal

“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,” said Reijo Laaksonen, Chief Medical Officer for Zora Biosciences, in a statement. “For instance, the 10-year cardiovascular death risk of a CHD patient may vary from 5 percent to over 20 percent.” 

The high-risk patients are not well identified with current clinical markers. The widely used LDL-cholesterol was not able to identify those CHD patients who were at the highest risk of cardiovascular death or myocardial infarction.

Laboratory tests such as CERT2 may offer an advantage over classical risk calculators in terms of their reliability, ease of use and predictive power, the company asserted. 

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. Common belief is that coronary heart disease (CHD) patients are at an equally high risk for cardiovascular events such as heart attack.  The study showed that there is a substantial variability in the risk of future cardiovascular events in CHD patients.