HAYWARD, Calif., Dec. 6 /PRNewswire/ -- Singulex, Inc. announced today the publication of research conducted by researchers at University of California, San Francisco (UCSF) and Singulex that reports on the clinical application of Singulex' Erenna(TM) Bioassay System (formally referred to as Singulex' Zept(x)(TM) System) for detecting cardiac troponin I (cTnI), a well-understood biochemical marker for myocardial damage. This research offers preliminary clinical results for the use of Singulex' customized Erenna assays in the early detection of acute myocardial infarction (AMI) and demonstrates diagnostic capabilities that meet recently redefined criteria for AMI diagnosis as outlined and recommended by the European Society of Cardiology and the American College of Cardiology.
In the paper, published in Clinical Chemistry and titled "Development and Preliminary Clinical Validation of a High Sensitivity Assay for Cardiac Troponin Using a Capillary Flow (Single Molecule) Fluorescence Detector," Alan Wu, Ph.D., professor of laboratory medicine at UCSF, and his colleagues at UCSF and Singulex evaluated Erenna's clinical performance in specimens from healthy individuals and patients with chest pain. Study findings showed the presence of cTnI in 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 American Heart Association estimates the annual incidence rate of myocardial infarction to be over a half a million new cases with the rate of mortality increasing with every 30 minutes that elapse before a patient is recognized and treated. The sensitive detection of specific biochemical markers for heart muscle damage will enable the earlier identification and treatment of patients at risk for adverse cardiac events," said Philippe Goix, Ph.D., president and CEO of Singulex. "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."
According to Wu, 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. He also notes that the data suggest that a high sensitivity assay can detect the presence of AMI earlier than with a conventional cTnI assay, and it may also identify more subjects at risk for future adverse events. These data need to be confirmed with larger healthy and diseased populations with known clinical outcomes, he adds.
"The emergence of highly specific and clinically relevant biochemical markers for disease diagnosis is exponentially increasing, as is our understanding of the mechanisms of many diseases. However, the clinical utility of new and existing biochemical markers has yet to be utilized due to the technological limits of detection, including the determination of normal biochemical levels in the body," said Goix. "Our technologies enable us to quantitatively establish biochemical levels in serum samples and develop specific and highly sensitive assays that can be used to track small changes in biochemical marker concentrations in order to diagnose and monitor disease."
Singulex' Erenna Bioassay System 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 this 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.
About Singulex
Singulex develops and commercializes innovative technology solutions that enable disease understanding and management for life science researchers and clinicians. Utilizing proprietary quantitative single molecule detection technology, Singulex develops customized biomarker diagnostic systems that can detect and quantify normal and abnormal protein biomarkers in a variety of biological samples with extreme sensitivity and accuracy. Singulex is currently conducting several pilot studies with academic and molecular diagnostic partners to validate the company's leading digital molecule detection platform, the Erenna(TM) Bioassay System, which will be commercially available in the first half of 2007. To learn more about Singulex, please visit us at www.singulex.com.
UC Disclaimer
The information stated above was prepared by Singulex to report the outcome of research conducted on its product (Erenna Bioassay System) and reflects solely the opinion of Singulex. Nothing in this statement shall be construed to imply any support or endorsement of Singulex or any of its products by The Regents of the University of California, its officers, agents and employees.
Singulex, Inc.CONTACT: Amy Blackley, Ph.D., of Porter Novelli Life Sciences,+1-619-849-6008, ablackley@pnlifesciences.com, for Singulex
Web site: http://www.singulex.com/
