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Endo Pharmaceuticals receives FDA complete response letter for OPANA ER

Endo Pharmaceuticals today announced that it received a complete response letter from the U.S. Food and Drug Administration regarding the New Drug Application for its new formulation of OPANA® ER designed to be crush resistant.

10 Jan 2011

New lab-on-a-chip technology detects protein in blood less than 30 minutes

While most blood tests require shipping a vial of blood to a laboratory for analysis and waiting several days for the results, a new device invented by a team of engineers and students at the University of Rhode Island uses just a pinprick of blood in a portable device that provides results in less than 30 minutes.

10 Jan 2011

Lancet World Report examines health risks associated with inaccurate TB tests, WHO's upcoming recommendations

With "scores of commercial serology tests for tuberculosis ... being sold in high-burden countries," the "WHO is due to release a negative policy recommendation - the first of its kind for the organisation" - after several reviews have "indicated poor performance of these tests," Lancet World Report writes in a piece that documents the health risks associated with a growing number of inaccurate TB tests.

10 Jan 2011

FDA grants marketing clearance for diaDexus's PLAC Test

diaDexus, a diagnostics company focused on the development and commercialization of patent-protected in vitro diagnostic products addressing unmet needs in cardiovascular disease, today announced that the U.S. Food and Drug Administration has cleared for marketing the automated version of its proprietary PLAC® Test.

9 Jan 2011

Critical Diagnostics' high sensitivity Presage ST2 Assay receives CE Mark approval

Critical Diagnostics announced today that it has received CE (Conformité Européenne) Mark for its high sensitivity Presage ST2 Assay and is commencing commercialization in Europe. The product is indicated for use as an aid in risk stratification of patients with heart failure or acute coronary syndrome. This regulatory milestone marks the first time that an assay has become commercially available for the clinical measurement of the biomarker soluble ST2.

7 Jan 2011

Amorfix's AD diagnostic assay detects aggregated beta amyloid in spinal fluid

Amorfix Life Sciences, a product development company focused on diagnostics and therapeutics for misfolded protein diseases, today announced preliminary results indicating that their human Alzheimer's disease (AD) diagnostic assay can detect a signal from aggregated beta amyloid in the spinal fluid (CSF) from AD patients.

7 Jan 2011

Hologic announces acquisition of Interlace Medical

Hologic, Inc., a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, announced today it has acquired Interlace Medical, Inc. (Interlace), the developer and manufacturer of the MyoSure hysteroscopic tissue removal system (MyoSure). Interlace's operations will be integrated within Hologic's GYN Surgical Products division.

From Hologic, Inc. 7 Jan 2011

BG Medicine enters agreement to develop galectin-3 test for Siemens' automated immunoassay platforms

BG Medicine, Inc. announced today that it has entered into an agreement with Siemens Healthcare Diagnostics Inc., a division of Siemens Healthcare, one of the world's largest suppliers of clinical diagnostics to the healthcare industry, for the development and commercialization of a galectin-3 test for Siemens' automated immunoassay platforms for clinical laboratories.

7 Jan 2011

Plexxikon, Genentech enter PLX4032 co-promotion agreement

Plexxikon, Inc., announced today that it has signed an agreement with Genentech to co-promote PLX4032 (RG7204) in the United States. PLX4032, an oral, novel kinase inhibitor that targets the oncogenic BRAF mutation, is being tested in late-stage clinical trials for the treatment of metastatic melanoma.

7 Jan 2011

Choosing between EGFR therapeutic options in metastatic colorectal cancer

Colorectal cancer (CRC) is the third most common cancer in men and women in the USA, with a new diagnosis made every 3.5 minutes and an associated death every 9 minutes.

6 Jan 2011

Lab21 acquires Microgen Bioproducts

Lab21 Limited, the Cambridge, UK-based specialist in personalised medicine and clinical diagnostics, has announced that it has acquired Microgen Bioproducts Ltd a UK company specialising in the development, manufacture and sale of diagnostic tests to identify diseases and organisms which pose a threat to health.

6 Jan 2011

Metabolon announces publication of 'Metabolomic Distinction and Insights into the Pathogenesis of Human Primary Dilated Cardiomyopathy'

Metabolon, the leader in metabolomics, biomarker discovery and analysis, announces the publication of "Metabolomic Distinction and Insights into the Pathogenesis of Human Primary Dilated Cardiomyopathy", in the European Journal of Clinical Investigation.

6 Jan 2011

JMD publishes results of Tissue of Origin Test validation, reproducibility study

Pathwork Diagnostics, Inc., a privately held molecular diagnostics company focused on oncology, announced today that The Journal of Molecular Diagnostics has published the results of a significant Tissue of Origin Test validation and reproducibility study.

6 Jan 2011

IRIS ships 3,000th iQ200 Automated Urine Microscopy Analyzer to Sarasota Memorial Hospital

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, has shipped its 3,000th iQ200Automated Urine Microscopy Analyzer.

5 Jan 2011

Predictive value of plasma galectin-3 levels in heart failure patients: Study

BG Medicine, a life sciences company focused on the discovery, development, and commercialization of novel diagnostics, today announced the publication of a study exploring the predictive value of plasma galectin-3 levels in heart failure (HF) patients with reduced and preserved ejection fraction.

5 Jan 2011

Fresenius Medical Care to acquire Euromedic's dialysis service business

Fresenius Medical Care AG & Co. KGaA, the world's largest provider of dialysis products and services, today announced the signing of a purchase agreement to acquire International Dialysis Centers ("IDC"), Euromedic International's ("Euromedic") dialysis service business.

4 Jan 2011

FDA clears first automated molecular tests to diagnose and differentiate HSV infection

BD Diagnostics, a segment of BD, announced today that it filed for U.S. Food and Drug Administration 510(k) clearance for the first fully automated molecular tests to diagnose and differentiate HSV types 1 and 2.

From BD (Becton, Dickinson and Company) 4 Jan 2011

MGH, Veridex establish research center of excellence on circulating tumor cell technologies

Massachusetts General Hospital (MGH) has entered into a collaborative agreement with Veridex LLC to establish a center of excellence in research on circulating tumor cell (CTC) technologies. The overall goal of the agreement is to develop and commercialize novel technologies for capturing and characterizing CTCs, solid tumor cells found at extremely low levels in the bloodstream, which may offer a key to noninvasive characterization of cancer and potentially to early detection.

4 Jan 2011

First whole genome sequence of Parsi breast cancer woman

Avesthagen Limited has yet again established its position as a leader in the successful application of next gen technologies as it announces the completion of the first Parsi breast cancer whole genome sequence of a 74-year-old Parsi woman with a heritable form of breast cancer. The incidence of breast cancer in most populations is strongly linked to a genetic basis but little is known about the variants at the present time.

4 Jan 2011

ACT, Roslin Cells collaborate to establish hESC line bank using single-ceblastomere technique

Advanced Cell Technology, a leader in the field of regenerative medicine, announced today that it has entered into a Memorandum of Understanding with Roslin Cells LTD of Scotland, in which the two companies contemplate a definitive collaboration agreement in the near future.

28 Dec 2010

Diagnostics News and Research

Endo Pharmaceuticals receives FDA complete response letter for OPANA ER

New lab-on-a-chip technology detects protein in blood less than 30 minutes

Lancet World Report examines health risks associated with inaccurate TB tests, WHO's upcoming recommendations

FDA grants marketing clearance for diaDexus's PLAC Test

Critical Diagnostics' high sensitivity Presage ST2 Assay receives CE Mark approval

Amorfix's AD diagnostic assay detects aggregated beta amyloid in spinal fluid

Hologic announces acquisition of Interlace Medical

BG Medicine enters agreement to develop galectin-3 test for Siemens' automated immunoassay platforms

Plexxikon, Genentech enter PLX4032 co-promotion agreement

Choosing between EGFR therapeutic options in metastatic colorectal cancer

Lab21 acquires Microgen Bioproducts

Metabolon announces publication of 'Metabolomic Distinction and Insights into the Pathogenesis of Human Primary Dilated Cardiomyopathy'

JMD publishes results of Tissue of Origin Test validation, reproducibility study

IRIS ships 3,000th iQ200 Automated Urine Microscopy Analyzer to Sarasota Memorial Hospital

Predictive value of plasma galectin-3 levels in heart failure patients: Study

Fresenius Medical Care to acquire Euromedic's dialysis service business

FDA clears first automated molecular tests to diagnose and differentiate HSV infection

MGH, Veridex establish research center of excellence on circulating tumor cell technologies

First whole genome sequence of Parsi breast cancer woman

ACT, Roslin Cells collaborate to establish hESC line bank using single-ceblastomere technique

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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