We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us
INTEGRA BIOSCIENCES AG

Download Mobile App




Certification Enables Development of New Technology in Next-Gen Immunodiagnostics

By LabMedica International staff writers
Posted on 06 Sep 2016
Print article
Image: The Sgx Clarity System, being developed for highly sensitive next-generation immunodiagnostic detection, provides simple and intuitive operation (Photo courtesy of Singulex).
Image: The Sgx Clarity System, being developed for highly sensitive next-generation immunodiagnostic detection, provides simple and intuitive operation (Photo courtesy of Singulex).
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.

"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.

Related Links:
Singulex


Platinum Member
COVID-19 Rapid Test
OSOM COVID-19 Antigen Rapid Test
One Step HbA1c Measuring System
GREENCARE A1c
POCT Fluorescent Immunoassay Analyzer
FIA Go
New
Gold Member
Fully Automated Cell Density/Viability Analyzer
BioProfile FAST CDV

Print article

Channels

Clinical Chemistry

view channel
Image: Reaching speeds up to 6,000 RPM, this centrifuge forms the basis for a new type of inexpensive, POC biomedical test (Photo courtesy of Duke University)

POC Biomedical Test Spins Water Droplet Using Sound Waves for Cancer Detection

Exosomes, tiny cellular bioparticles carrying a specific set of proteins, lipids, and genetic materials, play a crucial role in cell communication and hold promise for non-invasive diagnostics.... Read more

Molecular Diagnostics

view channel
Image: The study showed the blood-based cancer screening test detects 83% of people with colorectal cancer with specificity of 90% (Photo courtesy of Guardant Health)

Blood Test Shows 83% Accuracy for Detecting Colorectal Cancer

Colorectal cancer is the second biggest cause of cancer deaths among adults in the U.S., with forecasts suggesting 53,010 people might die from it in 2024. While fewer older adults are dying from this... Read more

Hematology

view channel
Image: The Gazelle Hb Variant Test (Photo courtesy of Hemex Health)

First Affordable and Rapid Test for Beta Thalassemia Demonstrates 99% Diagnostic Accuracy

Hemoglobin disorders rank as some of the most prevalent monogenic diseases globally. Among various hemoglobin disorders, beta thalassemia, a hereditary blood disorder, affects about 1.5% of the world's... Read more

Microbiology

view channel
Image: The new platform is designed to perform blood-based diagnoses of nontuberculosis mycobacteria (Photo courtesy of 123RF)

New Blood Test Cuts Diagnosis Time for Nontuberculous Mycobacteria Infections from Months to Hours

Breathing in nontuberculous mycobacteria (NTM) is a common experience for many people. These bacteria are present in water systems, soil, and dust all over the world and usually don't cause any problems.... Read more

Industry

view channel
Image: These new assays are being developed for use on the recently introduced DxI 9000 Immunoassay Analyzer (Photo courtesy of Beckman Coulter)

Beckman Coulter and Fujirebio Expand Partnership on Neurodegenerative Disease Diagnostics

Beckman Coulter Diagnostics (Brea, CA, USA) and Fujirebio Diagnostics (Tokyo, Japan) have expanded their partnership focused on the development, manufacturing and clinical adoption of neurodegenerative... Read more
Copyright © 2000-2024 Globetech Media. All rights reserved.