ALAMEDA, Calif., July 5, 2016 /PRNewswire-USNewswire/ -- Singulex, Inc., the leader in next generation immunodiagnostic technology powered by single molecule counting, announced the conclusion of a world-wide service agreement with Tecan Group to deliver comprehensive maintenance and support for its Sgx ClarityTM System. The Sgx Clarity System, currently in development and not yet approved for sale, is a fully automated, Next Generation Immunodiagnostics platform designed to bring the benefits of Singulex's SMC™ technology to hospital and reference labs worldwide. It is designed to overcome the existing sensitivity barriers in immunochemistry diagnostics.
"The world-wide service agreement with Tecan provides future users of the Sgx Clarity System confidence and peace-of-mind when using our next generation immunodiagnostic device," said Guido Baechler, president and chief executive officer, Singulex. "The proven sensitivity and application of the SMC technology which powers the Sgx Clarity System is designed to confidently support decision making regarding patient management. The backing of Tecan, a world leader for laboratory solutions, will instill the same level of confidence in the laboratorian operating the device."
Through the agreement, Tecan, a leading global provider of laboratory instruments and solutions in biopharmaceuticals, forensics and clinical diagnostics, will deliver comprehensively scheduled maintenance and technical support. Once the Sgx Clarity System is approved for sale, hospital and reference labs will have access to next generation immunodiagnostics with sensitivity targets that are more than 100-times greater than currently available devices and the confidence of expert maintenance and support across the globe.
"During just three years of close collaboration with Singulex we have designed, developed and produced the Sgx Clarity System to bring Singulex´ next-generation immunoassays to various diagnostic application fields." said Dr. Achim von Leoprechting, Head of Tecan Partnering, the company's division for OEM solutions: "In addition to the scale-up of instrument manufacturing we are excited to also provide tailored worldwide field service to Singulex customers to support the upcoming Sgx Clarity System launch and ramp-up."
Currently installed in investigational sites in Europe, the Sgx Clarity System will be previewed ahead of anticipated launch at the 68th AACC Annual Scientific Meeting & Clinical Lab Expo in Philadelphia, PA, July 31 to August 4, 2016. Attendees are encouraged to visit booth 3902 to experience next generation of immunodiagnostics in the form of the Sgx Clarity System. Pending review and evaluation of the Sgx Clarity System, CE Mark confirmation is anticipated in early 2017, with U.S. Food and Drug Administration clearance applications to be filed in 2017.
About Singulex, Inc.
Singulex is the next generation immunodiagnostic company developing Single Molecule Counting technology for clinical diagnostics and scientific discovery. Singulex's proprietary SMCTM technology enables physicians and scientists to detect biomarkers of disease that were previously undetectable. Powered by SMC technology, Singulex's ultrasensitive lab testing services are transforming patient care from reactive disease treatment to proactive health management.
The Singulex Clinical Lab Testing Services consist of a CLIA-licensed and CAP-accredited laboratory that currently provides a comprehensive menu of advanced cardiovascular disease testing utilizing SMC technology. Singulex has developed the Sgx ClarityTM System, a fully-automated in vitro diagnostics system that will bring the benefits of SMC technology to hospital and reference labs worldwide. For more information, please visit www.singulex.com.
Tecan (www.tecan.com) is a leading global provider of laboratory instruments and solutions in biopharmaceuticals, forensics and clinical diagnostics. The company specializes in the development, production and distribution of automated workflow solutions for laboratories in the life sciences sector. Its clients include pharmaceutical and biotechnology companies, university research departments, forensic and diagnostic laboratories. As an original equipment manufacturer (OEM), Tecan is also a leader in developing and manufacturing OEM instruments and components that are then distributed by partner companies. Founded in Switzerland in 1980, the company has manufacturing, research and development sites in both Europe and North America and maintains a sales and service network in 52 countries. In 2015, Tecan generated sales of CHF 440 million (USD 459 million; EUR 411 million). Registered shares of Tecan Group are traded on the SIX Swiss Exchange (TECN; ISIN CH0012100191).
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SOURCE Singulex, Inc.