In Vitro Diagnostics News and Research

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BIT Group opens new R&D Center of Excellence in the US

BIT Group has announced the opening of its new 22,500 sq. ft. "Center of Excellence for Life Science and IVD Products" for BIT USA.

9 Jun 2014

SurModics launches BioFX Liquid Nova-Stop Solution for TMB microwell substrates

SurModics IVD, Inc., a wholly owned subsidiary of SurModics, Inc. and a market leader for in vitro diagnostic assay components, today announced the launch of BioFX® Liquid Nova-Stop Solution, a non-corrosive, non-hazardous stop solution for TMB microwell substrates.

6 Jun 2014

Chinese FDA approves Waters ACQUITY UPLC TQD system as a medical device

Waters Corporation today announced that the Chinese Food and Drug Administration (CFDA) approved the registration of the ACQUITY UPLC TQD system for legal promotion and sale in China as a medical device for routine diagnostic applications and neonatal metabolites diseases screening.

5 Jun 2014

Immucor's PreciseType HEA test receives FDA approval to predict blood compatibility

Immucor, Inc., a global leader in transfusion and transplantation diagnostics, announced that the U.S. Food and Drug Administration has granted approval for the company's PreciseType HEA test.

23 May 2014

ERBA Diagnostics reports decrease in Q1 2014 net revenues

ERBA Diagnostics, Inc., a fully integrated in vitro diagnostics company, reported its financial results for the three months ended March 31, 2014.

15 May 2014

VisionGate develops LuCED test for early detection of lung cancer

VisionGate Inc., an in vitro diagnostics company that is developing a revolutionary, non-invasive test for the early detection of lung cancer and other applications, announced that positive results from a clinical study of its LuCED lung test will be highlighted in a poster presentation (Abstract #7547) during the American Society of Clinical Oncology (ASCO) 2014 Annual Meeting at McCormick Place in Chicago on Saturday, May 31, 1:15 to 5 p.m. in S Hall A2, poster board 155.

15 May 2014

Luminex announces group B strep as fifth assay planned for launch menu of ARIES

Luminex Corporation today announced that Group B Streptococcus (group B strep, GBS) is the fifth assay planned for the launch menu of its new sample-to-answer system, ARIES™.

From Luminex 12 May 2014

FDA-cleared BD MAX Enteric Bacterial Panel now available to detect bacterial pathogens

BD Diagnostics, a segment of leading global medical technology company BD (Becton, Dickinson and Company), announced today the availability of the FDA-cleared BD MAX Enteric Bacterial Panel for use on the BD MAX System.

From BD (Becton, Dickinson and Company) 7 May 2014

Bio-Rad Laboratories buys GnuBIO

GnuBIO, a privately-held life sciences company that has developed a droplet-based DNA sequencing technology, today announced that it was acquired by Bio-Rad Laboratories, Inc. With this acquisition, Bio-Rad will expand its Digital Biology Center and establish a research and development site in Cambridge, Massachusetts.

11 Apr 2014

Proteomics completes important milestone towards development of CDx test with validation of protein biomarkers

Proteomics now seeks a commercialisation partner to enter the RUO, LDT or IVD markets. Drug discovery company Proteomics International has completed an important milestone towards the development of a companion diagnostic (CDx) test with the validation of several of its protein biomarkers.

11 Apr 2014

Experts and entrepreneurs to gather at 2014 Biotech China on 14-16 May

With just one month until 2014 Biotech China, experts, entrepreneurs and decision-makers from the international biotechnology industry will gather at the heart of the Chinese biotechnology industry on May 14-16th, 09:00 AM-06:00 PM in Nanjing China.

10 Apr 2014

AB Sciex launches immunosuppressants kit to improve health care

Every organ transplant patient in the world faces the potential danger of his/her body rejecting a new organ, such as a heart, kidney or liver. Immunosuppressant drugs are required to help prevent rejection.

2 Apr 2014

UM researchers awarded FDA contract to expand high-throughput sequencing database

Researchers at the Institute for Genome Sciences at the University of Maryland School of Medicine have been awarded a research program contract from the U.S. Food and Drug Administration (FDA) to sequence, assemble, and annotate a population of bacterial pathogens using two high-throughput sequencing (HTS) technologies in support of the expansion of a vetted public reference database.

2 Apr 2014

GIN and Sigolis merge to create new company, Ginolis Oy

Global Innovation Network Oy (GIN) and Sigolis AB today announced a merger of the two companies. The new company, named Ginolis Oy, provides an innovative one-stop solution for the development and manufacturing of in vitro diagnostic (IVD) disposable products.

1 Apr 2014

Singulex signs agreement to co-develop the Sgx Clarity system with Tecan

Singulex, Inc., the developer and leading provider of Single Molecule Counting (SMC) technology for clinical diagnostics and scientific discovery, today announced an agreement to co-develop the Sgx Clarity system with Tecan, a leading global provider of laboratory automation instruments.

From Tecan 25 Mar 2014

Study: Stem cell transplant effective in halting degenerative disc disease of spine

Stem cell transplant was viable and effective in halting or reversing degenerative disc disease of the spine, a meta-analysis of animal studies showed, in a development expected to open up research in humans.

10 Mar 2014

Mindray's net revenues increase 16.5% to $368.4 million in fourth quarter 2013

Mindray Medical International Limited, a leading developer, manufacturer and marketer of medical devices worldwide, announced today its selected unaudited financial results for the fourth quarter and full year ended December 31, 2013.

From Mindray 4 Mar 2014

EKF Molecular Diagnostics to exhibit PointMan DNA-enrichment technology at Tri-Con 2014

EKF, announces that its subsidiary company EKF Molecular Diagnostics is exhibiting its ground-breaking PointMan DNA-enrichment tech.

From EKF Diagnostics 11 Feb 2014

BD announces commercial availability of CE-marked PAXgene Blood DNA Tube in Europe

BD, a leading global medical technology company, today announced the commercial availability of the CE-marked PAXgene Blood DNA Tube in Europe. The PAXgene Blood DNA Tube is the first blood collection tube designed specifically for in vitro diagnostic (IVD) genomic DNA testing. The product was developed by PreAnalytiX GmbH, a joint venture between BD and QIAGEN.

From BD (Becton, Dickinson and Company) 28 Jan 2014

EKF Diagnostics announces major breakthrough for PointMan DNA enrichment technology

EKF, announces a major breakthrough for its PointMan DNA enrichment technology for potential use in future cancer testing and treatment.

From EKF Diagnostics 22 Jan 2014