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Singulex Expands Clinical Evaluation of Sgx Clarity System in Europe

NEW YORK (GenomeWeb) – Singulex announced yesterday that it is expanding the clinical testing of its Sgx Clarity automated immunodiagnostics system at four European clinical research sites in order to evaluate its utility in cardiac care.

Sgx Clarity is based on Singulex's single molecule counting technology, which enables the detection of single molecules such as proteins and metabolites in complex biological samples. The company aims to launch the system as a CE-marked in vitro diagnostic in Europe and submit it for US Food and Drug Administration approval this year.  

According to Singulex, multiple clinical research studies of Sgx Clarity are underway at sites in Spain and in the UK, which will be expanded to further test the system.

At Hospital de Sant Pau in Barcelona, researchers have been using the Sgx Clarity cardiac troponin I (cTnl) assay to determine cardiac status in individuals with chest pain to avoid additional testing. Additional studies are now planned to examine using the system to rule out the presence of cardiovascular disease in patients and guide the use of supplementary procedures. Investigators at this hospital are also using the cTnl assay as part of a multimarker strategy for prognosis of readmissions in acute heart failure patients.

At St. George's University in London, researchers have completed an analytical evaluation of Sgx Clarity and are planning to evaluate cardiac troponin assays to rule out the presence of coronary disease in patients that present with suspected acute coronary syndrome. And at the University of Manchester, investigators are examining whether the Sgx Clarity cTnI assay can rule out acute coronary syndrome from a single blood test.

Singulex added that it is in discussions with researchers at other sites in Europe about Sgx Clarity installation and evaluation, including ones in Italy, Germany, and Norway.