Company plans to commercialize an ultrasensitive IVD immunoassay system by 2016
Singulex, Inc., the developer and leading provider of Single Molecule Counting (SMC) technology for clinical diagnostics and scientific discovery, today outlined development progress toward commercializing, as early as 2016, an ultrasensitive immunoassay system for the in vitro diagnostics (IVD) market.
Utilizing Singulex’s proprietary SMC technology, the fully-automated Sgx Clarity System is designed to detect low abundance biomarkers at levels down to femtograms/mL. The Company’s novel immunochemistry technology will be introduced to the American Association for Clinical Chemistry at the Annual Meeting taking place in Chicago from July 27 to 31, 2014 (booth number #1826).
“In a world where protein assay innovation has not advanced tremendously over the years, the elegant SMC technology behind our innovative Sgx Clarity System enables greater analytic sensitivity to detect minor increments above normal protein levels,” said Guido Baechler, President and Chief Executive Officer of Singulex. “The distinct advantage of Singulex’s SMC technology for physicians is that high precision, high sensitivity protein assays provide increased clinical utility.”
In March 2014, Singulex announced two agreements with leading providers of laboratory automation equipment. The co-development agreement with Tecan, a leading global provider of laboratory automation equipment, integrates Singulex’s SMC technology and customized consumables onto Tecan’s Freedom EVO® liquid handling platform. The supply agreement with Sony DADC BioSciences provides customized detection vessels designed and manufactured for the Sgx Clarity System. With these critical technology agreements in place, Singulex has subsequently achieved a key milestone by developing two prototype systems with customized modules, consumables, software, reagents and assays.
“I’m very pleased with the progress we’ve made towards commercialization of our Sgx Clarity platform,” said Lucy Hattingh, Senior Director, Diagnostics Program at Singulex. “We actively are engaging several leading clinical investigators and lab directors to further develop studies to support the analytical and clinical value of our portfolio of assays. Developing these assays on an IVD platform will enable Singulex to bring the clinical benefits of SMC technology to the global market.”