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System to be marketed by Singulex as an IVD and CE-marked device.
March 27, 2014
By: Michael Barbella
Managing Editor
Singulex Inc. and Tecan are teaming up to co-develop an in-vitro diagnostic immunoassay system. The partnership will incorporate Singulex’s Single Molecule Counting (SMC) technology and customized consumables onto Tecan’s Freedom EVO liquid handling platform. By integrating Singulex’s proprietary ultrasensitive detection technology with Tecan’s existing platform, Singulex expects to be able to commercialize the ultrasensitive immunoassay system for the in-vitro diagnostics (IVD) market as early as 2016.
The Sgx Clarity System will be the most sensitive IVD immunoassay system for routine diagnostics, Singulex claims. The fully-automated bench-top analyzer is targeted for clinical diagnostics laboratories and is being designed to be marketed by Singulex as an IVD and CE-marked device in the U.S. and global markets.
Singulex President/CEO Guido Baechler noted that the company expects the Sgx Clarity System to be able to detect low-abundance biomarkers and pathogens with significantly greater sensitivity than any existing immunoassay IVD systems.
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. Founded in Switzerland in 1980, the company has manufacturing, research and development sites in both Europe and North America.
The Freedom EVO® is a reliable, liquid handling tool and applications to automate a diverse range of applications including primary and secondary screening, cell growth and maintenance, nucleic acid sample preparation, hit picking, library management and sample weighing.
Singulex, Inc., the developer and leading provider of Single Molecule Counting (SMCTM) technology for clinical diagnostics and scientific discovery, today announced an agreement to co-develop the Sgx ClarityTM system with Tecan, a leading global provider of laboratory automation instruments. The partnership will incorporate Singulex’s SMC technology and customized consumables onto Tecan’s Freedom EVO® liquid handling platform. By integrating Singulex’s proprietary ultrasensitive detection technology with Tecan’s existing platform, Singulex expects to be able to commercialize the ultrasensitive immunoassay system for the in vitro diagnostics (IVD) market as early as 2016.
The Sgx Clarity System will be the most sensitive IVD immunoassay system for routine diagnostics. The fully-automated bench-top analyzer is targeted for clinical diagnostics laboratories and is being designed to be marketed by Singulex as an IVD and CE-marked device in the U.S. and global markets.
“We expect the Sgx Clarity System to be able to detect low-abundance biomarkers and pathogens with significantly greater sensitivity than any existing immunoassay IVD systems,” said Guido Baechler, President and Chief Executive Officer of Singulex. “By choosing Tecan’s innovative liquid handling platform, we are confident we will offer a fully-automated platform of the highest quality with a reduced time to market.”
About Tecan 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. Founded in Switzerland in 1980, the company has manufacturing, research and development sites in both Europe and North America.
About Singulex, Inc. Singulex is the developer and leading provider of Single Molecule Counting (SMCTM) technology for clinical diagnostics and scientific discovery. Singulex’s proprietary SMC technology enables physicians and scientists to detect biomarkers of disease that were previously undetectable. Powered by SMC technology, Singulex’s ultrasensitive immunoassay solutions and lab testing services are transforming patient care from reactive disease treatment to proactive health management and fueling the discovery and development of new therapeutics.
Singulex provides SMC technology to leading pharmaceutical R&D laboratories, clinical research organizations (CROs) and academic institutions around the world through its Research-Use-Only Erenna® Immunoassay System. 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 currently is developing the Sgx ClarityTM System, a fully-automated in vitro diagnostics system that will bring the benefits of its SMC technology to hospital and reference labs worldwide
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