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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

BD MAX MRSA Assay receives CE Mark approval

BD Diagnostics, a segment of BD, today announced that it obtained CE Marking for the BD MAX MRSA Assay to rapidly and accurately identify methicillin-resistant Staphylococcus aureus (MRSA) in patients.

From BD (Becton, Dickinson and Company) 24 Nov 2011

China Medical Technologies second quarter net revenues increase 18.1% to RMB238.5 million

China Medical Technologies, Inc., a leading China-based advanced in-vitro diagnostic company, announced its unaudited financial results for the second fiscal quarter ended September 30, 2011 ("2Q FY2011") today.

18 Nov 2011

SurModics to sell Pharma assets to Evonik for $30 million

SurModics, Inc., a leading provider of surface modification technologies to the healthcare industry, announced today that it has entered into a definitive agreement to sell its SurModics Pharmaceuticals assets to Evonik Industries AG for $30 million in cash.

2 Nov 2011

SFDA approves China Medical Technologies' colorectal cancer assay

China Medical Technologies, Inc., a leading China-based advanced in-vitro diagnostic company, today announced that China's State Food and Drug Administration has approved the Company's real-time PCR-based V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog assay as a companion diagnostic test for the use of a targeted drug for the treatment of colorectal cancer patients.

13 Oct 2011

NanoString introduces nCounter Analysis System

NanoString Technologies, Inc., a privately held provider of life science tools for translational research and developer of molecular diagnostics, today announced the launch of its second generation nCounter Analysis System.

From NanoString Technologies 13 Oct 2011

Asuragen announces data from Signature LTx v2.0 clinical study on leukemia

Asuragen, Inc. announced today that data from a study evaluating its Signature LTx v2.0, a CE-marked IVD test, for the multiplex detection of fusion transcripts associated with ALL, AML and CML leukemia, will be presented at the upcoming Planet XMAP Europe being held September 28 - 29, 2011 in Vienna, Austria.

27 Sep 2011

IVAX Diagnostics net revenues decrease 0.4% to $4,375,000 for quarter ended June 30, 2011

IVAX Diagnostics, Inc., a fully integrated in vitro diagnostics company, reports its financial results for the quarter ended June 30, 2011.

23 Aug 2011

Quanterix's ELISA precisely measures low abundance cytokines in Crohn's disease

Quanterix Corporation, a company enabling a new generation of molecular diagnostic tests based on its revolutionary Single Molecule Array technology, today announced results of a pilot study to measure biomarkers of inflammation from patients with Crohn's disease.

20 Aug 2011

China Medical first fiscal quarter net revenues increase 27.4% to US$36.7 million

China Medical Technologies, Inc., a leading China-based advanced in-vitro diagnostic company, announced its unaudited financial results for the first fiscal quarter ended June 30, 2011 today.

16 Aug 2011

China Medical receives SFDA approvals for TOP2A and prostate cancer FISH detection kits

China Medical Technologies, Inc., a leading China-based advanced in-vitro diagnostic company, today announced that it has received approvals for its prostate cancer FISH detection kit and Topoisomerase 2-alpha FISH detection kit from the State Food and Drug Administration of the People's Republic of China.

10 Aug 2011