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FDA clears Meridian's new C. difficile immunoassay

Meridian Bioscience, Inc., Cincinnati, Ohio today announced that it has received clearance from the U.S. Food and Drug Administration for a new Clostridium difficile immunoassay named Premier C. difficile GDH.

11 May 2011

FDA clears Affymetrix's new gene profiling reagents for use in microarray instrument system

Affymetrix, Inc. today announced that the U.S. Food and Drug Administration has cleared the addition of new gene expression reagents as accessories to its GeneChip Microarray Instrument System for in vitro diagnostic use, making Affymetrix the first in the industry to provide a comprehensive microarray-based clinical toolkit for diagnostic test development, signature discovery for companion diagnostics, and translational initiatives. Affymetrix Gene Profiling Reagents offer unparalleled convenience by simplifying assay workflow, decreasing hands-on time, and reducing quality control testing compared to research-use-only-produced products.

9 May 2011

Epigenomics, Life Technologies enter supply agreement for second-generation colorectal cancer blood test

Epigenomics AG, the cancer molecular diagnosis company, today announced the signing of a supply agreement with Life Technologies Corporation, a global provider of innovative life science solutions.

7 May 2011

MicroPhage receives FDA clearance for KeyPath MRSA/MSSA Blood Culture Test

The U.S. Food and Drug Administration today cleared the first test for Staphylococcus aureus infections that is able to quickly identify whether the bacteria are methicillin resistant or methicillin susceptible.

7 May 2011

BD MAX Open System for molecular testing launched in Europe

BD Diagnostics, a segment of BD, today announced the European launch of the BD MAX™ Open System for molecular testing, which will enable laboratories to run both laboratory and BD- developed assays and offer enhanced testing services that elevate the standards of care at their institutions.

From BD (Becton, Dickinson and Company) 6 May 2011

Quest Diagnostics' Simplexa C. difficile test is now available in Europe

Quest Diagnostics Incorporated, the world's leading provider of diagnostic testing, information and services, today announced the availability in Europe of the Simplexa C. difficile Universal Direct test on the 3M Integrated Cycler.

From Quest Diagnostics 6 May 2011

ChipDX identifies gene expression signature in early-stage breast tumors

ChipDX LLC, a New York-based molecular diagnostics and personalized medicine research company, has discovered a gene expression signature present in the cells of early-stage breast tumors that indicates the chance of the tumor recurring within 10 years.

4 May 2011

FDA grants Cepheid marketing clearance for Xpert Flu diagnostic test

Cepheid today announced it has received clearance from the U.S. Food & Drug Administration (FDA) to market Xpert® Flu. The diagnostic test, which runs on Cepheid's GeneXpert® System, simultaneously detects and differentiates Influenza A, Influenza B, and the 2009 H1N1 influenza virus in about one hour.

26 Apr 2011

EraGen, Applied BioCode partner to commercialize molecular diagnostics

Applied BioCode, Inc. and EraGen Biosciences Inc. today announced that they have entered into a strategic partnership and license agreement. The agreement provides EraGen with access to Applied BioCode's Barcoded Magnetic Bead technology and the CE-marked BioCode-1000 system.

19 Apr 2011

New dengue test receives FDA marketing clearance

The U.S. Food and Drug Administration today allowed marketing of the first test to help diagnose people with signs and symptoms of dengue fever or dengue hemorrhagic fever, a leading cause of illness and death in the tropics and subtropics.

11 Apr 2011

Cepheid receives FDA clearance for new assay to detect C. difficile infection

The U.S. Food and Drug Administration today cleared a test called the Cepheid Xpert C. difficile/Epi assay that is designed to rapidly detect the toxin B gene associated with Clostridium difficile infection, a cause of diarrhea that can lead to colitis, other serious intestinal conditions and death in severe cases.

11 Apr 2011

Bruker receives Health Canada approval for IVD MALDI Biotyper

At the 2011 Annual Meeting of the Canadian Association for Clinical Microbiology and Infectious Diseases, the companies i2A Canada and Bruker Ltd. announced together that they have met the relevant Health Products and Food Branch of Health Canada regulations for the Bruker IVD MALDI Biotyper, and that this product is now available for sale as a Class 1 Medical Device to all clinical microbiology sites in Canada.

8 Apr 2011

Luminex receives Medical Design Excellence Award for innovative MAGPIX system

Luminex Corporation has won a 2011 Medical Design Excellence Award in the category of In Vitro Diagnostics for its innovative MAGPIX system. Introduced in 2010, MAGPIX is a compact, versatile laboratory analysis platform designed to improve productivity by delivering multiple highly accurate, reproducible results from a single sample.

From Luminex 8 Apr 2011

EDMA endorses the campaign against excessive use of salt

EDMA, the European Diagnostic Manufacturers Association, fully endorses the 2011 World Salt Awareness Week theme “Salt and Men’s Health” as the latter reminds that more men than women die prematurely of cardiovascular diseases (CVD).

21 Mar 2011

Quest Diagnostics enters definitive merger agreement to acquire Celera for $8 per share

Quest Diagnostics Incorporated, the world's leading provider of diagnostic testing, information and services, and Celera Corporation, one of the world's pioneers in genetic diagnostics discovery and development, announced today that they have entered into a definitive merger agreement under which Quest Diagnostics will acquire Celera for $8 per share, representing a transaction value of approximately $344 million, net of $327 million in acquired cash and short-term investments.

From Quest Diagnostics 18 Mar 2011

ExonHit receives CE mark approval for AclarusDx to diagnose AD

ExonHit Therapeutics announces today CE marking of AclarusDx, its blood-based test intended to help in the diagnosis of Alzheimer's disease. This gives AclarusDx the status of In Vitro Diagnostic.

15 Mar 2011

Fluidigm fourth quarter revenue increases to $10.4 million

Fluidigm Corporation today announced its financial results for the fourth quarter and full year ended December 31, 2010.

9 Mar 2011

Wako i30 Immunoanalyzer incorporating Caliper's microfluidic LabChip technologies receives 510(k) clearance

Caliper Life Sciences, Inc. today announced that its licensee Wako Pure Chemical Industries, through its Wako Diagnostics division, has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its uTASWako® i30 Immunoanalyzer and AFP-L3 and DCP Assays, which are used to assess liver cancer risk in patients with chronic liver disease.

4 Mar 2011

Wako receives FDA 510(k) clearance for uTASWako i30 with AFP-L3 and DCP assays

Wako Diagnostics, a division of Wako Chemicals USA, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the uTASWako i30 instrument with alpha-fetoprotein L3 (AFP-L3) and des-gamma-carboxy prothrombin (DCP) in vitro diagnostic (IVD) tests in the USA.

2 Mar 2011

Supporters of open letter say 'Patent Amendment Bill' misses the point

An open letter with signatories including AusBiotech, Medicines Australia, Research Australia, the Walter and Eliza Hall Institute of Medical Research and Foursight has been addressed to members of the Australian Parliament, urging them to reject the ‘Patent Amendment (Human Genes and Biological Materials) Bill 2010’ as it misses the point on patient access and research exemption.

1 Mar 2011