Certification Enables Development of New Technology in Next-Gen Immunodiagnostics

By LabMedica International staff writers
Posted on 06 Sep 2016

ISO (International Organization for Standardization) 13485:2012 Certification has been granted by NSAI to help ensure high standard development of a proprietary Single Molecule Counting (SMC) technology for clinical use as a next-generation immunodiagnostic platform.

Singulex, Inc. (Alameda, CA, USA) is developing its SMC technology for clinical immunodiagnostics and scientific discovery, to enable physicians and researchers to detect disease biomarkers that were previously undetectable. Singulex Clinical Lab Testing Services currently provide a comprehensive menu of advanced cardiovascular disease testing utilizing SMC technology.

Image: The Sgx Clarity System, being developed for highly sensitive next-generation immunodiagnostic detection, provides simple and intuitive operation (Photo courtesy of Singulex).

"Receiving ISO 13485 certification validates the quality processes we have put in place to build Singulex into the Next Generation Immunodiagnostics Company, and are very pleased that NSAI recognizes Singulex as meeting the highest quality of standards," said Guido Baechler, Singulex president and CEO.

The certification from this independent organization ensures quality, safety, and efficiency, and prepares Singulex for market entry of its Sgx Clarity System, an automated in vitro diagnostics platform currently under development for hospital and reference labs worldwide. The system is currently undergoing evaluation in Europe and may achieve the CE-Mark by the end of Q1 2017. Singulex is planning to submit the Sgx Clarity System to the FDA in early 2017.

"Achieving ISO certification ensures that laboratorians, physicians, and patients will receive the highest quality diagnostic information as we commercialize the Sgx Clarity System, the most sensitive fully-automated immunoassay analyzer," said Baechler.

Singulex's SMC technology, which will power next-generation immunodiagnostics delivered through the Sgx Clarity System, provides immunodiagnostic assays that are 100 times more sensitive than those on other testing platforms, enabling unprecedented security to medical decisions. The sensitivity of SMC technology allows physicians to measure what they could not see before, allowing to better understand all stages of disease and help determine a patient's health status, including disease risk. SMC technology has been scientifically established through clinical studies involving greater than 100,000 patients, resulting in greater than 110 peer reviewed publications.

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