SelectScience
Join Free
NewsLife Sciences

Singulex Granted ISO 13485:2012 Certification

Singulex

Ensures Quality, Safety and Efficiency for Proprietary Technology

23 Aug 2016
Alex Waite
Editorial Assistant

Industry news

Singulex, 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.

Links

SingulexCompany website

Tags

Genome AnalysisGenomics, the study of genomes, includes functional genomics, evolutionary genomics and comparative genomics. There are many genomic technologies such as DNA sequencing of whole genomes, computational biology and bioinformatics. DNA and nucleic acids must be isolated and concentrated from cells for analysis with kits, automated analyzers and software. Other useful technologies for studying genomics include PCR, microarrays and electrophoresis.ImmunologyImmunological techniques measure and characterize immune responses. Immunology kits and analysis systems often use techniques such as ELISA, radioimmunoassay (RIA) and immunodiffusion assays, Immunohistochemistry, and flow cytometry. Immunologists use equipment such as flow Cytometers, plate readers, plate washers and fluorescent microscopes.Clinical GeneticsMolecular Genetics covers the analysis of hereditary genetic disease and chromosomal abnormalities. Genetics can be analysed using DNA, RNA, and protein microarrays, PCR, RT PCR and DNA sequencing. Genetic equipment includes genetic workstations, thermal cyclers, cooling blocks and electrophoresis products. Diagnostic kits are used for DNA / RNA extraction and purification.Next Generation SequencingNext-generation sequencing (NGS), also known as whole-genome sequencing, high-throughput sequencing and massive parallel sequencing, produces and analyses thousands to millions of nucleotide sequences at once. Sequencing systems operate via varying technologies depending on the manufacturer, including sequencing by synthesis, ligation, pyrosequencing, ion semiconductor and single-molecule real-time sequencing. For NGS, library preparation is paramount to successful sequencing. In this section, explore a range of library preparation kits, from targeted, amplicon-based or hybridization-based kits including epigenomic, transcriptomic and genomic workflows to fragmentation kits. Find the best next-generation sequencing products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. AutomationAutomation in laboratories and manufacturing processes enhances efficiency, precision, and scalability by reducing the need for manual intervention. It plays a critical role in improving productivity, minimizing human error, and accelerating workflows in fields like diagnostics, drug development, and industrial testing. Automation technologies include robotic systems, automated liquid handlers, and process control systems that streamline complex tasks and ensure consistent, reproducible results. Explore our peer-reviewed product directory to discover the best automation solutions, compare options, read user reviews, and get prices directly from manufacturers.In Vitro DiagnosticsIn vitro diagnostics (IVD) involve testing samples outside the body, typically in a laboratory, to diagnose diseases or conditions. IVD technologies include blood tests, molecular assays, and other bodily fluid tests, enabling accurate diagnosis and monitoring of diseases. These tests are essential for guiding treatment decisions in clinical settings. Browse our peer-reviewed product directory to find the best IVD solutions; compare products, check reviews, and get pricing directly from manufacturers.Molecular DiagnosticsMolecular diagnostics use an individual’s genetic code and gene expression to diagnose and monitor diseases. The technique is used increasingly in the field of infectious diseases and oncology, as well as areas such as coagulation, HLA typing and pharmacogenomics. Molecular diagnostics plays a pivotal role in personalized medicine.ISO Certification

Related articles