New Marker Detects Heart Attack Damage

cTnI is a well-understood biochemical marker for myocardial damage.

The new assay, called Erenna, has demonstrated diagnostic capabilities that meet recently redefined criteria for acute myocardial infarction (AMI) diagnosis as outlined and recommended by the European Society of Cardiology and the American College of Cardiology.

In a paper published in the November 2006 issue of Clinical Chemistry, Alan Wu, Ph.D., professor of laboratory medicine at the University of California at San Francisco (USA), and colleagues evaluated Erenna's clinical performance in specimens from healthy individuals and patients with chest pain. Study findings showed the presence of cTnI in the blood of healthy individuals, established normal baseline concentrations of cTnI (99th percentile was calculated to be 7 ng/l), and demonstrated that Erenna was able to detect small changes in concentration levels of cTnI, which could be an early indicator of AMI that is below the current and standard detectable limit (350 ng/l).

The Erenna assay was developed by Singulex (Haywood, CA, USA) and incorporates patented direct single-molecule detection technology with customized clinical assays that are capable of quantitatively detecting therapeutically significant biomarkers at sub-picogram concentration levels. In the study, Erenna was shown to reduce sample background significantly and enable the differential detection of dyes from other molecules with reproducible, signal-to-background efficiency.

"The research provides early data on the usefulness of Singulex' Erenna assays to facilitate more-specific detection of cardiac troponin I, a powerful biochemical marker for myocardial necrosis,” noted Philippe Goix, Ph.D., president and CEO of Singulex.

According to Prof. Wu, the results of this preliminary clinical study show that with the use of a high sensitivity assay, there are detectable troponin concentrations in a Gaussian distribution in the sera of healthy individuals. The data suggest that a high-sensitivity assay can detect the presence of AMI earlier than a conventional cTnI assay and may also identify more subjects at risk for future adverse events. However, Prof. Wu cautions that the data need to be confirmed with larger healthy and diseased populations with known clinical outcomes.



Related Links:
University of California at San Francisco
Singulex