Singulex is a commercial stage, privately held company pioneering Next Generation Immunodiagnostics (NGI). Singulex’s proprietary Single Molecule Counting technology is the backbone of NGI, and provides unprecedented ultra-sensitivity in the precision measurement of biomarkers. Such reliable ultra-sensitive accuracy provides definitive health status answers for physicians and patients resulting in improved health outcomes and reduced healthcare costs, without reducing delivery of care. Powered by SMC™ technology, Singulex NGI commercial offerings are transforming patient care from reactive disease treatment to proactive health management. Singulex currently delivers SMC technology through its state-of-the-art clinical lab, which has performed in excess of 3 million NGI tests on more than 780,000 patients. In 2017, Singulex will launch the SMC-powered Sgx Clarity™ instrument, a fully automated immuno-analyzer, initially for NGI cardiovascular products, and to be followed by oncology, infectious disease, neurodegenerative, and autoimmune diagnostic products. Singulex’s concurrent submission of the Sgx Clarity System to the FDA would, pending market clearance, enable subsequent commercialization in the United States, anticipated in 2018.