ALAMEDA, Calif., Sept. 8, 2017 /PRNewswire/ -- Singulex announced today the granting of a significant patent for determining the absence of coronary artery disease (CAD) in a patient based upon digital detection of either cardiac troponin-I (cTnI) or cardiac troponin-T(cTnT).
The patent covers counting individual digital events wherein each individual digital event comprises a signal representing a single molecule of cTnI or cTnT in a patient's blood sample. The broad claims apply to any assay method that uses digital detection to determine single molecules of cardiac troponin to rule out the presence of CAD when the troponin concentration is <10pg/mL (or ng/L).
"We are especially pleased about this new patent as it further secures our pioneering work of using ultrasensitive immunoassays to rule out coronary artery disease," said Guido Baechler, President and Chief Executive Officer of Singulex. "It also adds to our broad global IP portfolio around methods for measuring cardiovascular disease."
The Sgx Clarity CTnl assay and the Sgx Clarity system are CE marked for use in Europe; both are being prepared for regulatory review in the United States later this year.
"The digital approach for determining single molecules of troponin allowed us in collaboration with Dr. Alan Wu (University of California, San Francisco) to discover that healthy people have extremely low levels of cardiac troponins circulating in their blood. This discovery was very striking and has enabled clinicians to use a simple blood test to differentiate between people who don't have cardiovascular disease (healthy) from those that do have the disease," said John Todd, Senior Vice President and Chief Scientific Officer of Singulex.
The Singulex proprietary Single Molecule Counting technology has been validated in clinical studies involving more than 130,000 subjects, resulting in over 140 peer-reviewed publications. The Sgx Clarity cTnl assay and the Sgx Clarity system are CE marked. The company plans to submit data this year for regulatory clearance of the Sgx Clarity system and its ultra-sensitive cTnI assay in the United States, anticipating U.S. Food and Drug Administration clearance in 2018.
Singulex is an immunodiagnostics company at the forefront of Single Molecule Counting technology, a novel immunoassay technology recognized for unprecedented ultra-sensitivity in the precision measurement of biomarkers. Singulex is the developer of the Sgx Clarity system, a fully-automated, in vitro diagnostics platform powered by Single Molecule Counting technology. With up to 1000 times more sensitivity than existing technologies, Single Molecule Counting reveals the presence or absence of disease more clearly and definitively than was possible before. The Sgx Clarity system and Sgx Clarity assay received CE mark in 2017 and are commercially available in Europe; additional assays to detect and rule out infectious and inflammatory diseases are in development. Singulex is also developing a point-of-care platform and exploring applications beyond the clinical setting. For more information, please visit www.singulex.com.
About Coronary Artery Disease
More than 15 million Americans have coronary artery disease (CAD) and over 700,000 suffer an AMI every year.1 Measurements of cardiac troponin are a mainstay in the diagnosis and management of patients with suspected acute coronary syndrome (ACS).2 In addition, an association between cardiac troponin levels and stress-induced cardiac ischemia has previously been demonstrated,3 as well as risk of future cardiovascular disease (CVD).4-5
1 Mozaffarian D, Benjamin EJ, Go AS, et al. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015;131(4):e29-322.
2 Amsterdam EA, Wenger NK, Brindis RG, et al. 2014 AHA/ACC Guideline for the Management of Patients with Non-ST-Elevation Acute Coronary Syndromes: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;64(24):e139-228.
3 Sgx Clarity cTnI Assay: Instructions for Use. 06-0019-01. 2017.
4 Wang TJ, Wollert KC, Larson MG, et al. Prognostic utility of novel biomarkers of cardiovascular stress: the Framingham Heart Study. Circulation. 2012;126(13):1596-1604.
5 Neumann JT, Havulinna AS, Zeller T, et al. Comparison of three troponins as predictors of future cardiovascular events--prospective results from the FINRISK and BiomaCaRE studies. PloS One. 2014;9(3):e90063.
5 Apple FS, Steffen LM, Pearce LA, Murakami MM, Luepker RV. Increased cardiac troponin I as measured by a high-sensitivity assay is associated with high odds of cardiovascular death: the Minnesota Heart Survey. Clin Chem. 2012;58(5):930-935.