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PharPoint Research joins Medidata's ASPire to Win channel partner program

Medidata Solutions, a leading global provider of SaaS-based clinical development solutions, today announced that PharPoint Research, Inc., a North Carolina-based drug development service company, has joined Medidata's ASPire to Win® channel partner program, bringing the program's partner count to 30 organizations.

10 Jan 2011

Genetics Squared to change corporate name to Everist Genomics

Genetics Squared, a prognostics company focused on developing gene-based molecular assays for the prediction of cancer recurrence, today announced that it will change its corporate name to Everist Genomics and has appointed Prasad Sunkara, Ph.D. as its new President and Chief Executive Officer, effective immediately.

10 Jan 2011

nContact Surgical removes 'Surgical' from company name

nContact Surgical, Inc., a cardiac ablation device manufacturer, announced today that it is changing the name under which it operates from nContact Surgical, Inc. to nContact, Inc. As the pioneer of interdisciplinary epicardial and endocardial cardiac ablation, the change represents the Company's further evolution towards closed chest approaches to treating common cardiac arrhythmias.

10 Jan 2011

T2 Biosystems relocates to new 20,000 sq.ft. facility in Lexington

T2 Biosystems, Inc., a company developing next-generation medical diagnostic products, today announced that it has relocated to a newly renovated 20,000 sq.ft. facility located in Lexington, MA.

10 Jan 2011

Civitas receives $20 million Series A financing

Civitas Therapeutics, Inc., a privately held biopharmaceutical company focused on developing transformative pulmonary delivery therapies, announced today that it has secured a $20 million Series A financing from founding investor, Longitude Capital, along with co-lead Canaan Partners. The proceeds of the financing will be primarily used to advance Civitas' lead program for treating patients with Parkinson's disease through clinical proof-of-concept.

10 Jan 2011

Illumina announces next generation of iSelect custom genotyping products

Illumina, Inc. today announced its next generation of iSelect custom genotyping products that allow researchers to design custom arrays containing from 3,000 up to 1,000,000 markers, with the flexibility to add supplemental content to their array designs.

From Illumina, Inc. 10 Jan 2011

LabCorp to market On-Q-ity's circulating tumor cell platform

On-Q-ity, a next-generation oncology diagnostics company developing personalized and predictive tests to improve cancer therapy effectiveness, today announced a strategic alliance with Laboratory Corporation of America Holdings® (LabCorp). LabCorp will market On-Q-ity's novel and proprietary circulating tumor cell (CTC) platform to the biopharma industry to greatly accelerate and improve the cancer drug discovery and development process.

10 Jan 2011

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