Providing SMC-powered Next generation Immunodiagnostics to the clinical lab

Creating new opportunities with previously unattainable clinical diagnostics capability

Singulex is developing the Singulex Clarity^TM System, a fully-automated in vitro diagnostics platform that will bring the power and benefits of Singulex’s SMC technology and NGI to hospital and reference labs worldwide. The Clarity System will break through the current sensitivity barriers in immunochemistry diagnostics and bring previously unattainable clinical diagnostic capabilities to physicians and their patients. The Clarity System is designed to fit into the workflow of the routine clinical laboratory while providing unparalleled trusted sensitivity, precision, and accuracy, measuring biomarker concentrations down to the femtogram/mL level. This new platform will be launched in Europe during the second half of 2016 and a US launch, pending FDA clearance, is planned for 2017.

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The company will seek CE mark and FDA clearance for the new Sgx Clarity^TM System and a series of high-sensitivity tests, currently available only through Singulex’s U.S.-based Clinical Lab Testing Services, enabling patients all over the world to benefit from these advanced diagnostics.

In development; not yet available for commercial sale.

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