Singulex Inc, Alameda, Calif, has entered into a worldwide service agreement with Tecan Group, Männedorf, Switzerland, to deliver comprehensive maintenance and support for its Sgx Clarity system.
The 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 seeks to overcome existing sensitivity barriers in immunochemistry diagnostics.
“The worldwide service agreement with Tecan provides future users of the Sgx Clarity system confidence and peace-of-mind when using our next generation immunodiagnostic device,” says Guido Baechler, president and chief executive officer of Singulex. “The proven sensitivity and application of the SMC technology that 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 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 purportedly more than 100 times greater than currently available devices, along with the confidence of expert maintenance and support across the globe.
“During just 3 years of close collaboration with Singulex, we have designed, developed, and produced the Sgx Clarity system to bring Singulex’s next-generation immunoassays to various diagnostic application fields,” says Achim von Leoprechting, PhD, 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 AACC 2016. Pending review and evaluation, CE mark confirmation is anticipated in early 2017, with FDA clearance applications to be filed in 2017.
For more information, visit AACC booth 3902 or Singulex.