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Abbott receives CE Mark approval for new blood glucose monitoring system

Abbott today announced that it has received CE Mark for its new FreeStyle InsuLinx Blood Glucose Monitoring System, the first blood glucose monitoring device from Abbott that includes a mealtime insulin calculator for calculating suggested insulin doses.

10 May 2011

Fluidigm announces availability of genetic assays and primers for integrated fluidic circuit technology

Fluidigm Corporation today announced the availability of assays and primers optimized for the company's integrated fluidic circuit technology.

10 May 2011

Nexvax2- coeliac disease vaccine shows promising results in Phase I clinical trial

The world's first potential vaccine for coeliac disease has shown promising results for treating coeliac disease in a Phase I clinical trial and is expected to move to Phase II trials within the next year.

10 May 2011

USPTO grants patent to Rosetta's human hsa-miR-497 for use in diagnostic tests

Rosetta Genomics today announced that the United States Patent and Trademark Office has issued U.S. Patent No. 7,943,745, which is related to human hsa-miR-497 and its variants and covers the composition of matter.

10 May 2011

Abbott, Sucampo present lubiprostone phase 3 trial data in Japanese CIC at DDW 2011

Sucampo Pharmaceuticals, Inc. and Abbott today reported data from a phase 3 clinical efficacy trial in 124 Japanese chronic idiopathic constipation patients as well as from a phase 3 long-term safety trial in an additional 209 Japanese CIC patients.

10 May 2011

Dravet Syndrome Foundation awards OPKO Health grant to develop potential therapeutic agents

OPKO Health, Inc. announced today that it has been awarded a grant from the Dravet Syndrome Foundation to support the Company's efforts to develop potential therapeutic agents to treat a rare genetic disorder, Dravet Syndrome, also called severe myoclonic epilepsy of infancy, a severe form of epilepsy that usually appears during the first year of life.

9 May 2011

World's first urine-based tuberculosis diagnostics tool

Biomagnetics Diagnostics Corp., a developer of revolutionary diagnostics systems and technology for HIV, hepatitis, tuberculosis, cholera and malaria detection, and other innovative technologies, in a new video today unveiled the world's first urine-based tuberculosis diagnostics tool.

9 May 2011

Novavax first quarter net loss decreases to $7.5 million

Novavax, Inc. today announced its financial results for the first quarter ended March 31, 2011.

9 May 2011

Illumina announces price reduction in whole human genome sequencing projects

Illumina, Inc. today announced that it is significantly reducing the price for sequencing whole human genomes through the Illumina Genome Network.

From Illumina, Inc. 9 May 2011

caprotec bioanalytics closes Series B financing for EUR 5 million

caprotec bioanalytics GmbH, a privately held biopharmaceutical company offering the proprietary Capture Compound Mass Spectrometry platform technology for the analysis of small molecule – protein interactions, today announced a second closing of EUR 1 million to its Series B financing, increasing total equity for the round to EUR 5 million.

9 May 2011

FDA clears Affymetrix's new gene profiling reagents for use in microarray instrument system

Affymetrix, Inc. today announced that the U.S. Food and Drug Administration has cleared the addition of new gene expression reagents as accessories to its GeneChip Microarray Instrument System for in vitro diagnostic use, making Affymetrix the first in the industry to provide a comprehensive microarray-based clinical toolkit for diagnostic test development, signature discovery for companion diagnostics, and translational initiatives. Affymetrix Gene Profiling Reagents offer unparalleled convenience by simplifying assay workflow, decreasing hands-on time, and reducing quality control testing compared to research-use-only-produced products.

9 May 2011

Epigenomics presents Septin9 blood test study data in colorectal cancer at DDW 2011

Epigenomics AG, the cancer molecular diagnostics company, reports that Dr. Uri Ladabaum, Associate Professor in the Department of Gastroenterology and Hepatology at the School of Medicine of Stanford University, has presented the results of a health economic analysis of potential future colorectal cancer screening with Septin9 blood tests at the ongoing Digestive Disease Week 2011.

9 May 2011

Merrimack acquires development and commercialization rights to MM-398 in Europe, Asia

Merrimack Pharmaceuticals, Inc. and PharmaEngine, Inc. today announced the signing of an agreement under which Merrimack has acquired the rights to develop and commercialize MM-398 in Europe and Asia.

9 May 2011

Epigenomics, Life Technologies enter supply agreement for second-generation colorectal cancer blood test

Epigenomics AG, the cancer molecular diagnosis company, today announced the signing of a supply agreement with Life Technologies Corporation, a global provider of innovative life science solutions.

7 May 2011

MicroPhage receives FDA clearance for KeyPath MRSA/MSSA Blood Culture Test

The U.S. Food and Drug Administration today cleared the first test for Staphylococcus aureus infections that is able to quickly identify whether the bacteria are methicillin resistant or methicillin susceptible.

7 May 2011

Novartis receives FDA approval for Afinitor to treat pancreatic neuroendocrine tumors

Yesterday, the U.S. Food and Drug Administration approved the Novartis drug Afinitor for the treatment of advanced pancreatic neuroendocrine tumors.

7 May 2011

FDA approves Abbott's RX ACCULINK Carotid Stent System

Abbott today announced that the U.S. Food and Drug Administration approved the RX ACCULINK Carotid Stent System for the treatment of patients with carotid artery disease who are at standard risk of adverse events from carotid endarterectomy.

7 May 2011

Roche seeks FDA clearance for fully automated Chlamydia and gonorrhoeae test

Roche announced today that it has filed for FDA clearance of its Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG) tests.

7 May 2011

AdvanSource Biomaterials enters multi-year supply agreement with global coated medical devices company

AdvanSource Biomaterials Corporation, a leading developer of advanced polymer materials for a broad range of medical devices, today announced it has entered into a multi-year supply agreement with an international medical diagnostics device company engaged in the business of developing medical device coatings and developing, manufacturing and selling coated medical devices.

6 May 2011

BD MAX Open System for molecular testing launched in Europe

BD Diagnostics, a segment of BD, today announced the European launch of the BD MAX™ Open System for molecular testing, which will enable laboratories to run both laboratory and BD- developed assays and offer enhanced testing services that elevate the standards of care at their institutions.

From BD (Becton, Dickinson and Company) 6 May 2011

Diagnostics News and Research

Abbott receives CE Mark approval for new blood glucose monitoring system

Fluidigm announces availability of genetic assays and primers for integrated fluidic circuit technology

Nexvax2- coeliac disease vaccine shows promising results in Phase I clinical trial

USPTO grants patent to Rosetta's human hsa-miR-497 for use in diagnostic tests

Abbott, Sucampo present lubiprostone phase 3 trial data in Japanese CIC at DDW 2011

Dravet Syndrome Foundation awards OPKO Health grant to develop potential therapeutic agents

World's first urine-based tuberculosis diagnostics tool

Novavax first quarter net loss decreases to $7.5 million

Illumina announces price reduction in whole human genome sequencing projects

caprotec bioanalytics closes Series B financing for EUR 5 million

FDA clears Affymetrix's new gene profiling reagents for use in microarray instrument system

Epigenomics presents Septin9 blood test study data in colorectal cancer at DDW 2011

Merrimack acquires development and commercialization rights to MM-398 in Europe, Asia

Epigenomics, Life Technologies enter supply agreement for second-generation colorectal cancer blood test

MicroPhage receives FDA clearance for KeyPath MRSA/MSSA Blood Culture Test

Novartis receives FDA approval for Afinitor to treat pancreatic neuroendocrine tumors

FDA approves Abbott's RX ACCULINK Carotid Stent System

Roche seeks FDA clearance for fully automated Chlamydia and gonorrhoeae test

AdvanSource Biomaterials enters multi-year supply agreement with global coated medical devices company

BD MAX Open System for molecular testing launched in Europe

Event guide: 16th Clinical Biomarkers & CDx Summit Europe eBook

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

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