ORLANDO, Fla., Nov. 7 /PRNewswire/ -- Singulex Inc. announced today the presentation of findings that demonstrate the accurate detection of small changes of cardiac troponin I (cTnI) in patients experiencing brief, provoked myocardial ischemia using Singulex’s Erenna(TM) system and its optimized test for cTnI. This data was presented by Marc Sabatine, M.D., M.P.H. and David Morrow, M.D., M.P.H. at the American Heart Association Scientific Sessions 2007 in Orlando, Florida.
“Many proteins in the body may show slight changes in concentration indicative of disease, but current technologies often cannot see these changes, potentially missing the opportunity for expanded clinical utility of those biomarkers,” said Dr. Sabatine, associate physician in the Cardiovascular Medicine Division at Brigham and Women’s Hospital, Thrombolysis in Myocardial Infarction Study Group investigator and assistant professor of medicine at Harvard Medical School. “Cardiac troponin I clearly illustrates this. The marker is well-known to indicate heart attack, but by the time current methods can detect it, there is already irreversible tissue damage. With this study, we wanted to see if small changes in circulating cTnI levels could be measured in patients experiencing brief, provoked myocardial ischemia.”
Researchers obtained blood samples from 99 patients without recent angina. Blood was collected from those patients before stress testing and four hours after stress testing. Researchers measured the levels of cTnI using Singulex’s cTnI assay on the Erenna system. cTnI was detected in all patients before stress testing (median 4.4 pg/ml). Using perfusion imaging, researchers identified patients with transient ischemia and compared that data to cTnI levels measured following the stress test. In patients who showed no ischemia, cTnI levels remained the same, whereas circulating levels increased by 1.37 pg/ml (24 percent) in patients with mild ischemia (P=0.002) and by 2.08 pg/ml (40 percent) in patients with moderate to severe ischemia (P=0.0006). Using a current marketed assay competitive to the Singulex cTnI assay, researchers could not detect any differences in cTnI levels before and after stress testing.
“Our work on cardiac troponin I has opened up a new realm of possibilities in terms of developing advanced diagnostics,” said Philippe Goix, Ph.D., president and CEO of Singulex. “While the data our collaborators have generated so far is early stage, the Erenna system technology could power a change in how medicine is practiced. Cardiologists have theorized that cTnI could be used as a marker to help physicians decide whether a patient is experiencing or at risk for cardiac ischemia. However, existing technologies cannot detect levels low enough to realize this possibility. We are very pleased to have enabled Drs. Sabatine and Morrow to confidently measure changes in cTnI as part of these experiments.”
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 commercial digital molecule detection platform, the Erenna(TM) Immunoassay System. Singulex’s research and development facilities are located at the Center for Emerging Technologies in St Louis, Missouri, and the company’s commercial operations are based in Hayward, California. To learn more about Singulex, please visit us at http://www.singulex.com.
About ETAP
The Erenna(TM) Technology Access Program (ETAP) offers select clients the opportunity to use Singulex’s flagship Erenna system to improve and validate their vital immunoassays, adding as much as 1-3 logs of improvement in sensitivity and providing less than 20% coefficient of variability. ETAP includes the Erenna system, which is designed to detect and count single molecules, customized immunoassay development services, reagents, software and direct and personal client service.
CONTACT: Carolyn Hawley of Porter Novelli Life Sciences, +1-619-849-5375,
chawley@pnlifesciences.com, for Singulex Inc.
Web site: http://www.singulex.com/
