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Epigenomics presents data on Septin9 biomarker clinical study for colorectal cancer at UEGW

Epigenomics AG, the cancer diagnostics company, announced that new data obtained in a clinical study with the Company's proprietary Septin9 biomarker for the blood-based detection of colorectal cancer, were presented yesterday at the 18th United European Gastroenterology Week (UEGW) in Barcelona, Spain.

28 Oct 2010

IMD receives EPO patent for NADiA ultra-sensitive protein detection and cell phenotyping platform

IRIS International, Inc. a leading manufacturer of automated in-vitro diagnostics systems and consumables for use in hospitals and commercial laboratories worldwide, and a provider of high value personalized diagnostics testing services through its CLIA certified molecular diagnostics laboratory, today announced that Iris Molecular Diagnostics (IMD)has been granted Patent No. EP1842226B1 by the European Patent Office (EPO) covering aspects of IMD's NADiA ultra-sensitive protein detection and cell phenotyping platform, which can detect proteins in the femtogram (1 quadrillionth) per milliter range and phenotype single cells.

14 Oct 2010

Cancer cells utilize energy-rich intermediates of sugar metabolism: Research

Cancer research is facing a radical change of direction. Cancer cells do not obtain their energy from the breakdown of sugar to carbon dioxide and water, but from energy-rich intermediates of sugar metabolism instead.

6 Oct 2010

cobas TaqScreen DPX Test now available with CE Mark: Roche

Roche announced today that the cobas TaqScreen DPX Test for use on the cobas s 201 system is now available with the CE Mark. It is the first IVD test to offer complete coverage of all human genotypes of parvovirus B19 (B19V) and hepatitis A virus (HAV) in one assay.

5 Oct 2010

Scientia Advisors reviews growth in POC market

Rapid medical tests that can be analyzed in close proximity to patients in professional settings comprise the fastest growing segment of the global $37.5B in-vitro diagnostics industry, according to a new global review of the point-of-care (POC) diagnostics industry.

15 Sep 2010

Transgenomic expands EU distribution of SURVEYOR Scan K-RAS CE IVD mutation detection kit

Transgenomic, Inc. today announced that it completed the requirements for CE IVD labeling and has significantly expanded distribution of its SURVEYOR® Scan K-RAS mutation detection kit throughout most of the European Union. The SURVEYOR Scan K-RAS CE IVD kit is a member of Transgenomic's family of mutation detection kits, which features proprietary SURVEYOR endonuclease technology.

14 Sep 2010

Small IVDs can be kept on for longer periods

Small intravenous devices (IVDs) commonly used in the hand or arm do not need to be moved routinely every 3 days. A randomized controlled trial comparing regular relocation with relocation on clinical indication, published in the open access journal BMC Medicine, found that rates of complications were the same for both regimens.

10 Sep 2010

NEJM publishes study on Xpert MTB/RIF test for rapid molecular detection of TB and rifampin resistance

Cepheid today announced that its Xpert® MTB/RIF test was the subject of a study published in the latest edition of the New England Journal of Medicine (NEJM), "Rapid Molecular Detection of Tuberculosis and Rifampin Resistance." The complete study is now available online (http://www.nejm.org) and will appear in the September 9 print edition.

3 Sep 2010

Luminex launches FDA-cleared xTAG Cystic Fibrosis 60 Kit v2 diagnostic test

Luminex Corporation, the worldwide leader in multiplexed solutions, today announced the full commercial launch of its xTAG Cystic Fibrosis 60 Kit v2, a new diagnostic test that can simultaneously screen a single blood sample for up to 60 cystic fibrosis-causing genetic mutations in a matter of hours.

From Thermo Fisher Scientific Inc. 27 Aug 2010

IVD Technology to launch first annual Virtual Conference and Tradeshow

IVD Technology, the only trade media brand designed exclusively for manufacturers of in vitro diagnostic products, today announced the launch of its first annual Virtual Conference and Tradeshow to be held on September 28, 2010.

24 Aug 2010

Applied Biosystems 3500 Dx Series Genetic Analyzers now available in Asia Pacific Region

Life Technologies Corporation today announced that its Applied Biosystems 3500 Dx Series Genetic Analyzers, the first CE IVD-marked capillary electrophoresis system for nucleic acid analysis, are now available for sale in Australia, India, New Zealand, Singapore, and Taiwan.

23 Aug 2010

IRIS International announces approval of share repurchase program

IRIS International, Inc., a leading manufacturer of automated in-vitro diagnostics systems and consumables for use in hospitals and commercial laboratories worldwide, today announced that, effective immediately, its Board of Directors has approved a repurchase program for up to $10 million in shares of the Company's common stock over a twelve month period.

18 Aug 2010

IVAX Diagnostics second quarter 2010 operating expenses decrease 11.9%

IVAX Diagnostics, Inc., a fully integrated in vitro diagnostics company, reports its financial results for the quarter ended June 30, 2010.

17 Aug 2010

China Medical Technologies first-quarter fiscal 2010 revenues decrease 10.9% to RMB186.2 million

China Medical Technologies, Inc., a leading China-based advanced in-vitro diagnostic company, today announced its unaudited financial results for the first fiscal quarter ended June 30, 2010.

16 Aug 2010

A*STAR's Singapore Immunology Network, Institut M-rieux and bioM-rieux partner in TB research

An investment of S$3 million is being pumped into tuberculosis (TB) research by A*STAR's Singapore Immunology Network (SIgN), bioindustrial group Institut M-rieux and its in vitro diagnostics company bioM-rieux. The project, which involves setting up a joint laboratory in Biopolis, Singapore aims to investigate and identify novel biomarkers that could allow early identification of individuals at risk of TB disease development and disease reactivation. This could lead to better diagnosis and treatment for the highly contagious disease.

13 Aug 2010

Transgenomic second-quarter net loss increases to $1.1 million

Transgenomic, Inc. today reported financial results for the three and six months ended June 30, 2010, and provided a business update.

13 Aug 2010

AdvanDx announces European launch of CE-IVD marked GNR Traffic Light PNA FISH test

AdvanDx today announced the launch of its CE-IVD marked GNR Traffic Light™ PNA FISH® test in Europe. GNR Traffic Light PNA FISH is the first-ever test capable of simultaneously identifying Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa directly from positive blood cultures in less than 90 minutes.

12 Aug 2010

GenMark second-quarter revenues increase 162% to $651,000

GenMark Diagnostics, Inc. today reported revenues of $651,000 for the quarter ending June 30, 2010, a 162% increase over second quarter 2009. Net loss for the second quarter was $5.1 million, or $0.60 per share, compared to a net loss of $4.3 million and $1.08 per share for the same period last year.

10 Aug 2010

Epitomics launches EP Clone Rabbit Monoclonal Antibodies

Epitomics, Inc., the rabbit monoclonal antibody company, announces today the launch of EP Clone™ Rabbit Monoclonal Antibodies and their detection systems for pathology applications. These diagnostic immunohistochemistry (IHC) products are manufactured by the In Vitro Diagnostic (IVD) Division of the Company. This new line of products are developed in compliance with regulation for IHC antibodies and detection systems in the United States, these products are manufactured under FDA's Quality System Regulation (21 CFR, Part 820).

9 Aug 2010

IL releases new HemosIL HIT-Ab(PF4-H) assay

Instrumentation Laboratory (IL) today announced the release of the new HemosIL HIT-Ab(PF4-H) assay as a European CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices. Delivering results in minutes, the HemosIL HIT-Ab(PF4-H) assay detects total immunoglobulin against Platelet Factor 4-Heparin complexes, the antibodies associated with the pathology of HIT.

4 Aug 2010