Health Canada has approved Life Technologies' applied biosystems 3500 Dx /3500 xL Dx Genetic Analyzers CS2 for diagnostic use. The 3500xL Dx is an automated 24 capillary Sanger Sequencer instrument while the 3500 Dx is an eight capillary ...
Tags: Health Canada, Genetic Analyzers
Nanosphere has signed a distribution and collaboration agreement with Hitachi High-Technologies. With the agreement, Hitachi High-Technologies will gain exclusive rights to market Nanosphere products in Japan. The two companies also plan ...
Tags: Hitachi, Nanosphere Products
Co-Diagnostics has signed an agreement with DNA Logix, a molecular diagnostic assays developer, to buy certain technologies for genetic analysis in the clinical, industrial, and bio-threat segments. The technology to be gained is embodied ...
Tags: Suite of Technologies, Medicine
US-based molecular diagnostics company Insight Genetics has obtained ISO 9001:2008 certification for its quality management system. The audit, conducted by National Quality Assurance, evaluated the company's quality system that supports ...
Mobidiag, Genewave and Amplidiag have signed a definitive agreement to combine the three companies to set up a new company, which will offer integrated, high-multiplex diagnostic tests for infectious diseases. Headquartered in Helsinki, ...
Tags: Mobidiag, Genewave, Infectious Diseases
Bruker Daltonics, a developer of mass spectrometers and sample preparation systems, has entered into a strategic alliance with molecular diagnostics company Biodesix. Under the partnership, Bruker will support Biodesix's multivariate ...
Tags: Bruker Daltonics, spectrometers, sample preparation systems
DEKRA Certification has awarded ISO 9001:2008 certification to MDxHealth's CLIA certified and College of American Pathologists (CAP) accredited laboratory in Irvine, California, US. The certification confirms that MDxHealth's quality ...
Tags: ISO Certification, MDxHealth, Health
US-based diagnostic testing solutions provider Quidel has gained CE Mark for its Quidel Molecular Direct HSV 1+2/VZV assay for the differentiation and detection of herpes simplex viruses 1 and 2 (HSV 1+2) and varicella-zoster virus (VZV) in ...
Tags: CE Mark, Molecular Direct, diagnostic testing solutions
Quidel and Life Technologies have received 510(k) approval from US FDA to market the Quidel Molecular Direct C. difficile Assay with Life Technologies' QuantStudio Dx and 7500 Fast Dx Applied Biosystems Real-Time PCR Instruments. The ...
Tags: Quidel, Life Technologies, FDA Approval
Sysmex Europe, a subsidiary of Sysmex, has entered into a distribution agreement to provide sales and support for Endomagnetics' SentiMag system across the EMEA region. The SentiMag system, which features a highly sensitive SentiMag ...
Abbott has entered into a collaboration agreement with Janssen Biotech and Pharmacyclics to develop a molecular companion diagnostic test for investigational leukemia therapy. Under the agreement, Abbott will leverage its proprietary ...
Tags: leukemia therapy, Abbott, Pharmacyclics
Grant Instruments, a world-renowned supplier of scientific and life sciences products, has launched 12 new innovative life-science products to complement its existing Grant-bio range. The new range of laboratory equipment, designed for ...
The USFDA has accepted for filing Astellas Pharma's supplemental new drug application (sNDA) for Tarceva (erlotinib) tablets for a genetically distinct form of advanced lung cancer. Astellas is seeking approval to use Tarceva as the ...
Molecular diagnostic cancer assays developer Predictive Biosciences has named Pierre Cassigneul as the company's new chief executive officer (CEO). Prior to joining the company, Cassigneul served as board vice chairman and president and ...
Tags: Predictive Biosciences, Pierre Cassigneul, CEO, diagnostic cancer assays
HTG Molecular Diagnostics has obtained ISO 13485:2003 certification for the design, manufacture, and distribution of its patented qNPA technology-based products and services used in the analysis of gene expression. qNPA molecular ...
Tags: ISO Certification, analysis of gene expression, medical technology