In Vitro Diagnostics News and Research

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Samsung Medison highlights medical devices at RNSA 2012 meeting

Samsung Medison, a leading global medical devices company, announced that it participated the "RSNA (Radiological Society of North America) 2012", held in McCormick Place, Chicago from November 25th to 30th, in the biggest scale thus far.

27 Nov 2012

New report analyzes annual trends for biomarker FDA approvals since 2008

"Approval Trends for Biomarker-Based IVD Tests: Realizing the Promise of Personalized Medicine," a new report published by Amplion Research analyzes annual trends for FDA approvals since 2008 with some interesting findings.

27 Nov 2012

HORIBA Europe opens new R&D facility

HORIBA Europe has inaugurated its new research and technology center at the Saclay Technopole. Atsushi Horiba, President of the HORIBA Group, cut the ribbon opening the doors to HORIBA’s home for scientific innovation and cooperation.

19 Nov 2012

Affymetrix reports net loss of $17.9 million for third quarter 2012

Affymetrix, Inc., today reported its operating results for the third quarter of 2012. Total revenue for the quarter was $79.6 million, including approximately $17.6 million in revenue from eBioscience during the third quarter of 2012. This compares to total revenue of $64.0 million for the same period of 2011.

5 Nov 2012

Bruker introduces Toxtyper clinical mass spectrometry solution

At the annual conference of the DGKL, Bruker today announced the European launch of the novel, automated Toxtyper clinical mass spectrometry solution to meet the increasing demands for LC-MS/MS throughput and data quality in routine toxicology laboratories without the need for mass spectrometry expertise.

26 Sep 2012

Diabetes prevention: an interview with Julian Baines, CEO of EKF Diagnostics

NICE public health guideline 38 ‘Preventing type 2 diabetes: Risk identification and interventions for individuals at high risk’.

From EKF Diagnostics 3 Sep 2012

PathGEN signs Powered by Affymetrix Program agreement

Affymetrix, Inc. and PathGEN Dx Pte. Ltd., a spin-off molecular diagnostics company founded by researchers from the Genome Institute of Singapore, today announced they have signed a Powered by Affymetrix (PbA) Program agreement

24 Aug 2012

Roche MagNA Pure 96 System's CE certified IVD version launched

Today, Roche announced the launch of its new CE certified IVD version of the MagNA Pure 96 System for automated sample preparation. By providing a maximum of lot-to-lot consistency and highest quality, the new MagNA Pure 96 System is designed to even better fulfill the needs of diagnostic customers. In 2011, the IVD version of MagNA Pure 96 was already introduced in the US.

From Roche Sequencing and Life Science 13 Aug 2012

Clovis Oncology, Foundation Medicine enter diagnostic collaboration

Foundation Medicine, Inc. and Clovis Oncology, Inc. announced today that they have entered into a diagnostic collaboration.

6 Aug 2012

Cepheid launches new Xpert BCR-ABL Monitor test

Cepheid today announced the release of an updated Xpert BCR-ABL Monitor test, now incorporating lot-specific standardization using the WHO (World Health Organization) BCR-ABL standards.

25 Jul 2012

ERBA Diagnostics to showcase full range of products at AACC annual meeting

ERBA Diagnostics, Inc., a fully integrated in vitro diagnostics company, is pleased to announce that Suresh Vazirani, Chairman of ERBA Diagnostics, will be a key note speaker at the International Marketing Brief (IMB) in conjunction with the AACC.

16 Jul 2012

SurModics IVD to introduce BioFX TMB Extended Range HRP Microwell Substrate

SurModics IVD Inc., a wholly owned subsidiary of SurModics, Inc. and a market leader for in vitro diagnostic assay components, is pleased to announce it will launch BioFX TMB Extended Range HRP Microwell Substrate (TMBX) at the American Association for Clinical Chemistry show in Los Angeles, CA from July 17-19, 2012.

9 Jul 2012

Evolution of Advanced IVDs Conference to take place on September 19-20, 2012

IVD Technology Magazine announces the Evolution of Advanced IVDs Conference on September 19-20, 2012 at the San Diego Convention Center.

29 Jun 2012

SQI raises CDN $754,000 in third and final tranche of private placement

SQI Diagnostics Inc., a life sciences company that develops and commercializes proprietary technologies and products for advanced microarray diagnostics, announced today it has raised gross proceeds of CDN $754,000 from the closing of the third and final tranche of a non-brokered private placement of 430,713 units priced at $1.75 per Unit.

15 Jun 2012

Enzo Biochem third quarter total revenue increases 4% to $26 million

Enzo Biochem, Inc. today reported results for the fiscal third quarter ended April 30, 2012.

12 Jun 2012

End-to-end regulatory solution for medical device companies in Europe offered by new partnership between ELC and mdi Europa

ELC GROUP, the pan-European pharmaceutical regulatory affairs organisation, today announces that it has formed a preferred European partner relationship with mdi Europa GmbH, a global regulatory consultancy for medical device and IVD companies.

6 Jun 2012

Ventana, leading cancer researchers partner to commercialize novel IHC primary antibody

Ventana Medical Systems, Inc., a member of the Roche Group, has signed an exclusive license agreement with the German Cancer Research Center and University Hospital Heidelberg, Germany to commercialize a novel immunohistochemistry (IHC) primary antibody developed by researchers Andreas von Deimling, MD, Hanswalter Zentgraf, PhD and David Capper, MD, to detect the V600E BRAF mutation protein.

1 Jun 2012

SQI Diagnostics reports net loss of $1,350,000 for second quarter 2012

SQI Diagnostics Inc., a life sciences company that develops and commercializes proprietary technologies and products for advanced microarray diagnostics, today announced its financial and operational results for the three and six months ended March 31, 2012.

31 May 2012

Laboratory middleware solution to be exhibited by NoemaLife at this year’s AACC

NoemaLife, Europe’s leading provider of clinical and hospital software solutions, will exhibit the company’s HALIA middleware for clinical chemistry, microbiology and molecular biology labs at this year’s AACC (American Association of Clinical Chemists) Annual Meeting (15-19 July 2012, Los Angeles, CA).

30 May 2012

ABL receives CE-IVD approval for DeepChek and ViroScore Suite clinical genotyping solutions

Advanced Biological Laboratories (ABL) announced today that DeepChek and ViroScore Suite clinical genotyping solutions are now CE-IVD (In Vitro Diagnostics) approved for commercial use in Europe and other countries that recognise CE certification.

28 May 2012