November 15, 2018 Clinical Research/Diagn. Licensing, IP, and Legal Liq. Handling & Robotics

Dynex Technologies Receives CFDA Approval to Supply AGILITY Automated ELISA Processing System to China

Company’s portfolio approval demonstrates dedication to clinical labs in the Asia-Pacific region November 15, 2018 08:14 AM Pacific Standard Time CHANTILLY, Va.–(BUSINESS WIRE)–Dynex® Technologies, Inc., announced today that it received Chinese Food and Drug Administration (CFDA) approval to market its DYNEX AGILITY® instrument and software for quantitative immunoassay measurements of analytes, including proteins and microbiological specimens. “With... Read more

November 13, 2018 Clinical Research/Diagn. Product Launch

bioMérieux launches the BIOFIRE® FILMARRAY® Pneumonia Panels with FDA clearance and CE Marking

13 November, 2018 bioMérieux, a world leader in the field of in vitro diagnostics, today announced the Food and Drug Administration (FDA) 510(k) clearance of the BIOFIRE® FILMARRAY® Pneumonia Panel and the CE-Mark of the BIOFIRE® FILMARRAY® Pneumonia Panel plus. The BIOFIRE®  FILMARRAY®Pneumonia Panels aid in the diagnosis of lower respiratory tract infections. bioMérieux’s molecular biology affiliate, BioFire Diagnostics, builds upon its... Read more

November 13, 2018 Clinical Research/Diagn. Product Launch

New Diagnostic Test Helps Hospitals More Quickly Identify and Treat Emerging Antibiotic-Resistant Bacteria

Fully-automated BD Phoenix™ CPO Detect Test Receives U.S. FDA Clearance FRANKLIN LAKES, N.J., Nov. 13, 2018 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the U.S. Food and Drug Administration 510(k) clearance of the BD Phoenix™ CPO detect test, which will allow hospitals to identify infections caused by carbapenemase-producing organisms (CPOs). The... Read more

November 13, 2018 Clinical Research/Diagn. Product Launch

New Diagnostic Test Helps Hospitals More Quickly Identify and Treat Emerging Antibiotic-Resistant Bacteria

FRANKLIN LAKES, N.J., Nov. 13, 2018 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the U.S. Food and Drug Administration 510(k) clearance of the BD Phoenix™ CPO detect test, which will allow hospitals to identify infections caused by carbapenemase-producing organisms (CPOs). The test may help hospitals contain the... Read more

November 9, 2018 Clinical Research/Diagn. M&A, Partnerships

bioMérieux acquires a majority stake in Hybiome and strengthens its presence both in China and in the immunoassay market

09 November, 2018 bioMérieux, a world leader in the field of in vitro diagnostics, today announces the acquisition of a majority holding in Suzhou Hybiome Biomedical Engineering Co.Ltd. This announcement follows the acquisition of a minority stake in July 2018. Founded in 2009 and based in Suzhou (China), Hybiome is specialized in automated immunoassay tests. The... Read more

November 7, 2018 Clinical Research/Diagn.

BD Announces Clinical Trial Data for the LUTONIX® 014 Drug-Coated Balloon Below-The-Knee IDE Trial

FRANKLIN LAKES, N.J., Nov. 7, 2018 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the safety and efficacy data from the LUTONIX® Drug-Coated Balloon (DCB) IDE, level 1 clinical trial for a below-the-knee (BTK) indication. The clinical study is a prospective, global, multicenter, randomized, controlled trial comparing... Read more

November 6, 2018 Clinical Research/Diagn. Product Launch

Quanterix Expanding Transformative Biomarker Technology Portfolio Into Oncology

NOVEMBER 07, 2018 Launching Test Bed for up to 10-plex assays with Simoa Sensitivity and Specificity to Advance Cancer Research Lexington, Mass. – November 7, 2018 — Quanterix Corporation (NASDAQ:QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, today announced an Early Access Program for the latest advance in Simoa Sensitivity assays... Read more

November 1, 2018 Clinical Research/Diagn. Life Science Tools Mass Spectrometry Product Launch

Agena Launches Bone Marrow Engraftment Assay For Chimerism Analysis

San Diego, CA, November 1, 2018 – Agena Bioscience, a global provider of molecular testing solutions, today announced the release of the Chimeric ID Panel designed to reduce the time and cost of performing chimerism analysis for bone marrow engraftment monitoring studies. The SNP-based panel is designed for research use with the MassARRAY® system and is... Read more

October 30, 2018 Clinical Research/Diagn. Lab Top-10 Life Science Tools Product Launch

Illumina Launches TruSight Oncology 500 to Power Comprehensive, Accurate, Pan-Cancer Tumor Profiling

SAN DIEGO–(BUSINESS WIRE)–Illumina, Inc. (NASDAQ: ILMN) today announces the launch of TruSightTM Oncology 500 (TSO 500), a comprehensive pan-cancer assay designed to identify known and emerging tumor biomarkers. TruSight Oncology 500 utilizes both DNA and RNA from subject tumor samples to identify key somatic variants underlying tumor progression, such as small DNA variants, fusions, and... Read more

October 30, 2018 Clinical Research/Diagn. Life Science Tools Product Launch

Cofactor Genomics Launches ImmunoPrism™ Immune Profiling Kit, for Use in Clinical Sequencing Laboratories

October 30, 2018 08:00 ET | Source: Cofactor Genomics –Enables in-house, RNA-based, solid tumor profiling with powerful, cloud-based informatics tools to inform critical clinical decisions– SAN FRANCISCO, Oct. 30, 2018 (GLOBE NEWSWIRE) — Cofactor Genomics, a clinical RNA sequencing and translational assay developer, announced today the launch of a RNA-based immune profiling kit developed for laboratories wishing to derive... Read more