In Vitro Diagnostics News and Research

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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

Merck-Chimie to commercialize CardioGenics' proprietary paramagnetic beads

CardioGenics Holdings Inc., developer of the ultra-sensitive QL Care™ Point-Of-Care (POC) analyzer and products for the immunoassay segment of the In-Vitro Diagnostics market, announced that CardioGenics Inc. and Merck Chimie S.A.S. have agreed on a plan to commercialize CardioGenics' proprietary paramagnetic beads, with shipments to Merck-Chimie's customers scheduled to start mid-September 2010.

4 Aug 2010

IRIS International closes AlliedPath acquisition

IRIS International, Inc., a leading manufacturer of automated in-vitro diagnostics systems and consumables for use in hospitals and commercial laboratories worldwide, announced today that it has closed the acquisition of AlliedPath, Inc., a private, early stage high complexity, CLIA-certified laboratory focused on oncology and molecular diagnostics.

2 Aug 2010

Affymetrix second-quarter total revenue decreases to $71.7 million

Affymetrix, Inc., today reported its operating results for the second quarter of 2010. Total revenue for the quarter was $71.7 million, in line with previously announced expectations, as compared to total revenue of $81.6 million in the second quarter of 2009.

22 Jul 2010

DermaGenoma announces availability of PsoriasisDX Genetic Test as CE Marked product for PsA

Molecular dermatology research and development innovator DermaGenoma, Inc. today announced that the PsoriasisDX Genetic Test for Psoriatic Arthritis is now available as a CE Marked product under the European In Vitro Diagnostic Directive.

21 Jul 2010

Corgenix, ELITech establish broad strategic alliance

Corgenix Medical Corporation, a worldwide developer and marketer of diagnostic test kits, and the ELITech Group, a Paris, France-based, privately held group of companies and worldwide manufacturer and distributor of in-vitro diagnostic equipment and reagents, today announced a broad strategic alliance.

19 Jul 2010

CardioGenics Holdings' subsidiary signs second product agreement with Merck Chimie

CardioGenics Holdings Inc., developer of the ultra-sensitive QL Care Point-Of-Care analyzer and products for the immunoassay segment of the In-Vitro Diagnostics market, announced that the Company's subsidiary, CardioGenics Inc., has entered into an agreement with Merck Chimie S.A.S. to adopt its proprietary biological-linking technology to Merck-supplied magnetic beads designed to increase yields in antibody manufacturing.

15 Jul 2010