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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

SQI closes second 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 $2.333 million through the second tranche of a non-brokered private placement of 1,333,428 units priced at $1.75 per Unit.

18 May 2012

SurModics second quarter revenue declines 8% to $12.2 million

SurModics, Inc., a leading provider of surface modification and in vitro diagnostic technologies to the healthcare industries, today announced results for its fiscal 2012 second quarter.

9 May 2012

LifeCodexx completes PraenaTest clinical study on trisomy 21

LifeCodexx today announced the successful completion of the clinical validation study of its noninvasive test method for the detection of fetal trisomy 21 from maternal blood using Next Generation sequencing.

2 May 2012

FDA clears Great Basin’s first C. diff molecular diagnostic test

Great Basin Corporation, a privately-held life sciences company developing sample-to-result molecular diagnostic solutions, today announced that the U.S. Food and Drug Administration (FDA) has granted approval for its first molecular diagnostic test for Clostridium difficile.

2 May 2012

Innovation in healthcare without borders: An invaluable contribution of diagnostics

For the third year in a row, the European Diagnostic Manufacturers Association (EDMA) has been one of the strategic partners of the European Commission in organising the Innovation in Healthcare without Borders conference.

17 Apr 2012

FDA grants 510(k) clearance for QIAGEN’s molecular detection PCR technology

QIAGEN N.V. today announced that the U.S. Food and Drug Administration (FDA) has granted two 510(k) clearances for its real-time PCR (polymerase chain reaction) instrument Rotor-Gene Q MDx and a compatible test for the detection of Influenza A/B, the artus Infl A/B RG RT-PCR Kit, for in vitro diagnostic use.

From QIAGEN Manchester Limited 17 Apr 2012

FDA clears BD MAX assay for detecting GBS DNA in Lim Broth cultures

BD announced today the U.S. Food and Drug Administration clearance of the BD MAX Group B Streptococcus (GBS) Assay and Clinical Laboratory Improvement Amendments (CLIA) moderate complexity test categorization on the second-generation BD MAX System.

From BD (Becton, Dickinson and Company) 29 Mar 2012

DNA Electronics licenses technology platform for rapid, lab-free DNA detection to geneOnyx

DNA Electronics Ltd. a developer of semiconductor solutions for real-time DNA and RNA detection, today announces that it has licensed its ground-breaking Genalysis technology platform for rapid, lab-free DNA detection to geneOnyx, a company that is delivering on-the-spot genetic analytics services for cosmetics and skincare applications.

19 Mar 2012

Enzo Biochem to unveil data on AmpiProbe HCV assay at ESCMID meeting

Enzo Biochem Inc. announced today that the company will present for the first time peer-reviewed data on detection of hepatitis C virus (HCV) using its novel AmpiProbe technology platform, which provides low cost and high sensitivity real-time nucleic acid amplification assays.

9 Mar 2012

Roche grants in vitro diagnostics product license for real-time PCR technology to LTC

Roche and Life Technologies Corporation announced today that they have entered into two license agreements to allow LTC to expand its PCR offerings for diagnostics applications.

23 Feb 2012

China's SFDA approves Affymetrix GeneChip System 3000Dx v.2

Affymetrix, Inc. today announced that its GeneChip System 3000Dx v.2 (GCS 3000Dx v.2) has been approved by China's State Food and Drug Administration (SFDA) for in vitro diagnostic use.

16 Feb 2012

FDA allows marketing of Stratify JCV Antibody ELISA test for PML

Today, the U.S. Food and Drug Administration allowed marketing of the first test to help determine the risk for a rare brain infection called progressive multifocal leukoencephalopathy (PML) in people using the drug Tysabri (natalizumab) to treat multiple sclerosis (MS) or Crohn's disease.

21 Jan 2012

HDC, NeoGenomics sign worldwide licensing agreement to develop LDT

Health Discovery Corporation, a molecular diagnostics leader in the use of patent protected advanced mathematical techniques for personalized medicine, has entered into an exclusive worldwide licensing agreement with NeoGenomics, Inc. for laboratory developed tests in the Field of hematopoietic and solid tumor cancers excluding breast cancer, which was previously licensed to Quest Diagnostics and Smart Personalized Medicine and excluding cancer of the retina which was previously committed to Retinalyze, LLC.

9 Jan 2012

Georgia Bio announces 2012 Deals of the Year for pharma, biopharma and medical device companies

Georgia Bio announced its 2012 Deals of the Year for pharmaceutical, biopharmaceutical and medical device companies in four categories - public and private financings, fast growing companies, acquisitions and SBIR grants - reflecting a broad range of activity.

From Medtronic 7 Jan 2012