Image: The Sgx Clarity system, an integrated single molecule counting technology-reading instrument (Photo courtesy of Singulex).
Coronary artery disease (CAD) is the leading cause of death worldwide and a significant proportion of ambulatory health care visits are for evaluation of patients with suspected CAD, with an estimated 1.5% of the population presenting with chest pain every year.
Up to 1,000 times more sensitive than existing technologies, Single Molecule Counting-based diagnostics are the first ultra-sensitive tests to routinely and effectively identify minute quantities of protein biomarkers, giving clinicians greater insight, confidence, and certainty in disease detection, rule-out and patient management.
Singulex (Alameda, CA, USA), a global immunodiagnostics company pioneering ultra-sensitivity in the precision measurement of protein biomarkers, announced it has applied the CE Mark to its ultra-sensitive troponin I assay (cTnl), the first offered on the Sgx Clarity system, a fully-automated, in vitro diagnostics platform powered by Single Molecule Counting technology.
The Singulex Sgx Clarity cTnl Assay quantitatively measures the biomarker troponin at levels far lower than existing technologies. The Sgx Clarity cTnl Assay is indicated to be used in conjunction with clinical evaluation for ruling out cardiac ischemia in patients suspected of having coronary artery disease (CAD). Efficient rule-out helps avoid the costs and adverse effects of additional expensive and potential unnecessary testing, such as stress tests, and allows clinicians to focus resources on the sickest patients.
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 will submit data for regulatory clearance of the Sgx Clarity system and the Sgx Clarity cTnI Assay in the USA later this year, anticipating US Food and Drug Administration clearance in 2018.
Alessandro Sionis, MD, the director of the Intensive Cardiac Care Unit, Hospital de la Santa Creu i Sant Pau (Barcelona, Spain), said, “This is a tremendously attractive concept, especially, from an urgent care perspective. The increased sensitivity and analytical precision of this troponin I assay has the potential to greatly improve the safety and efficiency of myocardial ischemia rule-out in patients especially those presenting to the Emergency Department with chest pain.”
Hospital de la Santa Creu i Sant Pau