In Vitro Diagnostics News and Research

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EKF Diagnostics to exhibit two POC testing analyzers for diabetes management at Arab Health

EKF, will be exhibiting two newly introduced point-of-care testing analyzers for rapid assessment of diabetes and related conditions.

From EKF Diagnostics 8 Jan 2014

Eurofins Medigenomix, Orion Diagnostica Oy sign co-exclusive technology license agreement

Eurofins Medigenomix, a part of the Eurofins Genomics Business line of Eurofins Scientific and Orion Diagnostica Oy, an in vitro diagnostics company specialising in the development, production and sales of diagnostic test systems, announced that they have signed a co-exclusive technology license agreement. Orion Diagnostic Oy owns the global rights for the SIBA- isothermal nucleic acid detection technology in all fields.

17 Dec 2013

Multiplicom launches MID kit for Illumina MiSeq and MASTR kits for MODY, ADH and HCM

Multiplicom NV, a specialist in the development, production and commercialization of innovative molecular genetic tests based on massively parallel sequencing, today announces that it is launching a CE/IVD labeled MID kit for Illumina MiSeq together with three new germline mutation detection MASTRTM kits enabling the identification of individuals at risk for maturity onset diabetes of the young, autosomal dominant hypercholesterolemia, and hypertrophic cardiomyopathy.

2 Dec 2013

AB SCIEX launches IVD-MS Analyzer CE marked for general in vitro diagnostic use in Europe

Continuing to rapidly expand its presence in the clinical diagnostics field, AB SCIEX, a global leader in analytical technologies, today announced the launch of its AB SCIEX IVD-MS™ Analyzer CE marked for general in vitro diagnostic use in Europe.*

27 Nov 2013

Bruker receives FDA clearance to market MALDI Biotyper CA System in the U.S.

Bruker Corporation today announced that it has been granted U.S. FDA clearance under Section 510(k) to market its MALDI Biotyper CA System in the United States for the identification of Gram negative bacterial colonies cultured from human specimens.

26 Nov 2013

Argos Soditic-managed funds announce acquisition of Cisbio Bioassays

The funds managed by Argos Soditic announce the acquisition, together with the management, of Cisbio Bioassays. This cutting-edge biotechnology company is the leader in the field of products and services for human in vitro diagnostics and pharmaceutical research.

18 Nov 2013

Medix Biochemica to launch antibody production services for IVD assays at MEDICA 2013

Medix Biochemica, producer of monoclonal antibodies for the global IVD industry and diagnostic rapid tests, is presenting its MedixMAB by Design and MedixMAB Manufacturing antibody production services to the European market at MEDICA 2013, Dusseldorf, Germany, 20-23 November, Hall 3, Stand F44.

14 Nov 2013

ERBA Diagnostics’ net revenues increase 83% to $6,941,000 in third quarter 2013

ERBA Diagnostics, Inc., a fully integrated in vitro diagnostics company, reported its financial results for the three and nine months ended September 30, 2013.

11 Nov 2013

Supply agreement for Clinical Chemistry reagents for the Pictus analyzer range announced by Diatron and Medicon

Diatron MI Plc and Medicon Hellas SA have recently signed an exclusive supply agreement for an extensive range of high quality clinical chemistry reagents for use on the Diatron Pictus range of Clinical chemistry analyzers in all international markets but excludes the USA.

From Diatron 2 Oct 2013

Advamed 2013 conference to focus on global opportunities and challenges in medical technology industry

AdvaMed 2013: The MedTech Conference begins today at the Walter E. Washington Convention Center in Washington, D.C. with a major emphasis on the opportunities and challenges facing the medical technology industry in an increasingly global marketplace.

23 Sep 2013

Ventana gets CFDA approval for VENTANA ALK immunohistochemistry assay

Ventana Medical Systems, Inc., a member of the Roche Group, today announced the approval of the VENTANA ALK immunohistochemistry assay by the Chinese Food and Drug Administration as a companion diagnostic to aid in the identification of patients for Pfizer's CFDA-approved oncology product XALKORI (crizotinib).

12 Sep 2013

Nuclea Biotechnologies Acquires Wilex' U.S. Subsidiary

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9 Sep 2013

S&P Capital IQ commences Standard & Poor's Factual Stock Report coverage on Epigenomics AG

S&P Capital IQ announced today that it has commenced Standard & Poor's Factual Stock Report coverage on Epigenomics AG.

7 Sep 2013

65 metabolites in urine simultaneously measured by clinical IEM-by-NMR screening study in Turkey

At the 12th International Congress of Inborn Errors of Metabolism (www.iciem2013.com), Bruker announces another milestone in the cost-effective use of NMR (nuclear magnetic resonance) spectroscopy screening as a clinical research tool for metabolic screening and small molecule in vitro diagnostics (IVD) research and validation.

4 Sep 2013

Mount Sinai, Exosome Partner On Body Fluid Molecular Diagnostics

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22 Aug 2013

FDA approves first mass spectrometer system in U.S. for identification of bacteria, yeasts

The U.S. Food and Drug Administration today allowed marketing in the U.S. of the first mass spectrometer system for automated identification of bacteria and yeasts that are known to cause serious illness in humans.

22 Aug 2013

FDA recalls Nova Max Blood Glucose Test Strips due to faulty readings

The U.S. Food and Drug Administration is working with Nova Diabetes Care to recall 21 lots of glucose test strips marketed under the brand names Nova Max Blood Glucose Test Strips and Nova Max Plus Glucose Meter Kits. Nova Diabetes Care announced a recall on July 26, 2013.

1 Aug 2013

FDA allows marketing of Xpert MTB/RIF Assay for treatment of TB

The U.S. Food and Drug Administration today allowed marketing of the Xpert MTB/RIF Assay, the first FDA-reviewed test that can simultaneously detect bacteria that cause tuberculosis and determine if the bacteria contain genetic markers that makes them resistant to rifampin, an important antibiotic for the treatment of TB.

26 Jul 2013

EKF Diagnostics introduces STAT-Site M ß-HB strip test for DKA assessment

EKF Diagnostics, the global in vitro diagnostics business, announces the worldwide launch of the new STAT-Site M ß-HB, following successful CE marking.

From EKF Diagnostics 25 Jul 2013

Bruker introduces AVANCE-IVDr platform for NMR clinical research and screening

Bruker today announces a standardized nuclear magnetic resonance (NMR) spectroscopy platform for its clinical and diagnostics partners that enables cost-effective, high-performance NMR clinical screening and IVD-by-NMR discovery, development and validation of novel NMR assays.

24 Jul 2013