Singulex, Alameda, Calif, has received CE marking for the Sgx Clarity system, a fully automated, in vitro diagnostics (IVD) platform, powered by single molecule counting technology. Single molecule counting technology measures biomarkers at the lowest levels, revealing the presence—or absence—of disease, so that clinicians can provide the right treatment at the right time, resulting in better outcomes and cost savings.

“Leading cardiologists, laboratorians, and health providers know that Singulex’s single molecule counting technology has advanced our knowledge of cardiac troponin and its ability to effectively understand heart health and status,” says Paul Collinson, MD, professor of cardiovascular biomarkers at St. George’s University of London. “By applying the power and sensitivity into an easy-to-use IVD platform via the Sgx Clarity system, we can now put that technology to use and make better informed treatment decisions, improve care management, and help lower cost.”

Guido Baechler,

Guido Baechler, Singulex.

“This is a momentous day for Singulex,” says Guido Baechler, president and CEO of Singulex. “We are pleased to achieve [the] CE mark and begin the sale of our Sgx Clarity system in Europe. Our vision is to revolutionize immunodiagnostics to guide treatment decisions and improve healthcare systems across the globe. We continue to develop assays to detect and rule out highly preventable diseases, such as cardiac, infectious, and inflammatory diseases.”

Singulex plans to submit a CE mark application for a cardiac troponin I (cTnI) assay in Europe and will also submit data for regulatory clearance of the Sgx Clarity system in the United States, anticipating FDA clearance in 2018. The company is also developing a point-of-care platform for its single molecule counting technology and is exploring additional applications beyond the clinical setting.

For more information, visit Singulex.