Singulex Granted ISO 13485:2012 Certification
Ensures Quality, Safety and Efficiency for Proprietary Technology
23 Aug 2016Singulex, Inc., the leader in Next Generation Immunodiagnostics powered by Single Molecule Counting technology, has been granted ISO (International Organization for Standardization) 13485:2012 Certification by certifying body NSAI.
Singulex president and chief executive officer Guido Baechler said, “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.”
The certification from this independent organization ensures quality, safety and efficiency, and prepares Singulex for market entry of the Sgx ClarityTM System, a fully-automated in vitro diagnostics platform currently under development for hospital and reference labs worldwide. The system is currently undergoing market evaluation in Europe, and the company expects the Sgx Clarity System to achieve the CE-Mark by the end of Q1 next year and is planning to submit the Sgx Clarity System to the FDA in early 2017.
Baechler added, “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.”
Singulex’s SMCTM technology 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 them to better understand all stages of disease and help determine a patient’s health status and disease risk. SMC technology will power next generation immunodiagnostics delivered through the Sgx Clarity System. SMC technology has been scientifically proven through clinical studies involving greater than 100,000 patients, resulting in greater than 110 peer reviewed publications.