Global immunodiagnostics company Singulex, Alameda, Calif, has recently applied the CE mark to its ultrasensitive assay for cardiac troponin I (cTnl), the first to be offered on the company’s Sgx Clarity system, a fully-automated, in vitro diagnostics platform powered by single molecule counting technology.

The Sgx Clarity cTnl assay quantitatively measures the biomarker troponin at levels far lower than existing technologies. The assay is indicated for use 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 potentially unnecessary testing, such as stress tests, and enables clinicians to focus resources on the sickest patients.

“This is a tremendously attractive concept, especially from an urgent care perspective,” says Alessandro Sionis, MD, director of the acute and intensive cardiac care unit at the University of Barcelona’s Hospital de la Santa Creu i Sant Pau. “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.”

Up to 100 times more sensitive than existing technologies, single molecule counting-based diagnostics are the first ultrasensitive 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.

Guido Baechler,

Guido Baechler, Singulex.

“This is a significant milestone for Singulex as well as for laboratorians, clinicians, and patients,” says Guido Baechler, president and chief executive officer of Singulex. “We are working closely with European clinical research sites to develop best practices and training for optimal introduction and utility of our Sgx cTnl test for cardiac ischemia rule-out in patients suspected of having coronary artery disease.”

The Singulex proprietary single molecule counting technology has been validated in clinical studies involving more than 130,000 subjects, resulting in more than 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 United States later this year, and is anticipating FDA clearance in 2018.

For more information, visit Singulex.