SAN DIEGO, Aug. 1, 2017 /PRNewswire/ -- Findings from two studies presented at the American Association of Clinical Chemistry (AACC) Annual Scientific meeting demonstrate the analytical performance of the ultra-sensitive Sgx Clarity® cTnI assay used on the Sgx Clarity system, a fully-automated, in vitro diagnostics platform powered by Single Molecule Counting technology, and the clinical performance in cardiovascular disease rule-out (A-080 and A-082).
The Sgx Clarity cTnI 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 Sgx Clarity cTnI assay has high and reproducible analytical sensitivity and precision for the detection of cardiac troponin I, demonstrating its significant potential to change the way we diagnose and stratify risk of acute myocardial infarction and coronary artery disease," said Jordi Ordóñez-Llanos, MD, PhD, Senior Consultant and Professor of Clinical Biochemistry, and lead investigator of one study.
Dr. Ordóñez-Llanos and colleagues at the Hospital de la Santa Creu i Sant Pau, Barcelona, Spain, and Dr. Paul Collinson at St. George's University Hospitals NHS Foundation Trust, London, United Kingdom, demonstrated the analytical performance of the Sgx Clarity cTnI assay. Limits of blank (LoB) and detection (LoD) for the Sgx Clarity cTnI assay were verified at 0.02 and 0.08 pg/mL (ng/L), respectively. The limit of quantitation (LoQ) at 20% CV was determined to be 0.14 pg/mL and the 10% functional sensitivity was 0.53 pg/mL. These levels of sensitivity significantly exceed what can be obtained with other in vitro diagnostic platforms.
In a clinical study, conducted in the Hospital de la Santa Creu i Sant Pau, Barcelona, the investigators determined a cutpoint for ruling in and out acute myocardial infarction (AMI) using the 99th percentile for apparently healthy adults (6.74 pg/mL). This cutpoint was then used to evaluate the clinical performance of the Sgx Clarity cTnI assay in 144 chest-pain patients (without ST-elevation AMI) prospectively presenting to the emergency room. The authors concluded that "the Sgx Clarity cTnI assay significantly increased the proportion of patients showing values below the limits of clinical decision at admission and one hour later, allowing the use of rapid rule-out strategies."
"What makes our assay so unique and clinically valuable is the degree of sensitivity and high precision we are able to offer with our Single Molecule Counting technology," said John Todd, Chief Scientific Officer, Singulex. "Working with our key opinion leaders, we continue to gain important insights into its use and potential to change the way coronary artery disease is diagnosed around the world."
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
The Singulex proprietary Single Molecule Counting technology has been validated in clinical studies involving more than 130,000 subjects, resulting in over 130 peer-reviewed publications. 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.
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.
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