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Correlogic Systems' OvaCheck blood test for detection of epithelial ovarian cancer receives CE Mark

Correlogic Systems, Inc. announced today that OvaCheck, the company's blood test for the detection of epithelial ovarian cancer, has fulfilled European Union regulatory requirements (CE marking) for distribution and sale of the test. The path is now cleared for the test to be made available to patients in Europe through their physicians.

9 Jun 2010

Hitachi Software, OriGene announce co-marketing agreement

Hitachi Software Engineering America, Ltd. and OriGene Technologies, Inc. today announced a co-marketing agreement to jointly promote OriGene's multiplex assays built on Luminex xMAP/Bio-Plex technology and Hitachi Software's MasterPlex software suite for analysis and reporting of multiplex assay data.

29 May 2010

FDA grants Premarket Approval for Roche Diagnostics' Elecsys Antibody to hepatitis C virus assay

Roche Diagnostics announced today that the U.S. Food and Drug Administration (FDA) granted Premarket Approval for its Elecsys Antibody to hepatitis C virus (anti-HCV) assay. The Elecsys Anti-HCV assay is an in-vitro diagnostic test for the qualitative detection of total antibodies to hepatitis C virus in human serum or plasma.

From Roche Sequencing and Life Science 28 May 2010

CardioGenics Holdings announces further update on status of its 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 today a further update regarding the status of its agreement with Merck Chimie S.A.S., one of the largest manufacturers and distributors of magnetic beads for the diagnostics market.

28 May 2010

T2 Biosystems raises $15 million to accelerate development of next generation diagnostic platform

T2 Biosystems, Inc., a company developing the first decentralized clinical diagnostic solution that eliminates extensive sample preparation and enables rapid molecular and immunodiagnostic testing on a single instrument, today announced that it has raised approximately $15 million in a Series C financing. Proceeds from the financing will be used to accelerate the development and commercialization of T2 Biosystems' next generation diagnostic platform for use in the decentralized setting.

25 May 2010

Choir singing induces state of stimulated regeneration in IBS patients

A Swedish investigation has compared choir singing and group discussion in irritable bowel syndrome in the current issue of Psychotherapy and Psychosomatics.

19 May 2010

Winners of 2010 IADR/GSK Innovation in Oral Care Awards announced

The International Association for Dental Research and GlaxoSmithKline Consumer Healthcare today announced the 2010 winners of the annual IADR/GSK Innovation in Oral Care Awards. The three prestigious awards recognize research in innovative oral care technologies that may maintain and improve oral health and the quality of life.

15 May 2010

SQI announces poster presentations on novel diagnostic assays at 7th International Congress on Autoimmunity

SQI Diagnostics Inc., a medical systems automation company focused on evolving laboratory-based biomarker testing, today announced data from oral and poster presentations that highlights the Company's leadership position in the autoimmune diagnostics space.

14 May 2010

IMD seeks FDA regulatory clearance for NADiA ProsVue prostate cancer prognostic test

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 its IRIS Molecular Diagnostics (IMD) subsidiary has submitted a 510(k) pre-market notification application to the U.S. Food and Drug Administration (FDA) requesting regulatory clearance for NADiA®ProsVue™, a prostate cancer prognostic test. The test is designed to help physicians identify patients at low risk of cancer recurrence post radical prostatectomy.

29 Apr 2010

China Medical Technologies' AUTOMAGLIA 90 analyzer and Down Syndrome Screening receive SFDA approval

China Medical Technologies, Inc., a leading China-based advanced in-vitro diagnostic company, today announced that it received approval for its AUTOMAGLIA 90 fully-automated ECLIA analyzer as well as Down Syndrome screening kit from the State Food and Drug Administration of China.

29 Apr 2010

Immunomedics' blood assay for PAM4-protein can detect pancreatic cancer and predict early relapse

Immunomedics, Inc., a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today reported that a new blood test using the Company's proprietary humanized antibody, clivatuzumab or PAM4, predicted a partial response in an initial set of patients treated with a combination of the antibody labeled with yttrium-90 (Y-90) and gemcitabine. Results were presented at the 101st Annual Meeting of the American Association for Cancer Research.

21 Apr 2010

Beckman Coulter awarded new agreement with Premier Purchasing Partners for laboratory systems and supplies

Beckman Coulter, Inc., a leading developer, manufacturer, and marketer of products that simplify, automate, and innovate complex biomedical testing, announced that effective April 1, 2010, it has been awarded a new agreement with Premier Purchasing Partners, the group purchasing unit of Premier, Inc., to provide a full range of core laboratory systems and supplies. Premier is one of the nation's largest healthcare purchasing networks, with more than 2,300 member hospitals and 64,000 additional healthcare sites.

From Beckman Coulter Diagnostics 15 Apr 2010

Siemens Healthcare Diagnostics announces new contract with Premier Purchasing Partners

Siemens Healthcare Diagnostics announces a new three-year contract with Premier Purchasing Partners, L.P., the group purchasing unit of Premier Inc., that includes Siemens powerful integrated diagnostic systems, several specialty diagnostic instruments, and a comprehensive menu of diagnostic tests for Premier's more than 2,300 member hospitals and 64,000 additional healthcare sites.

29 Mar 2010

Meridian Bioscience revises fiscal 2010 guidance, expects net sales between $145M and $153M

Meridian Bioscience, Inc., Cincinnati, Ohio today announced that it is revising downward its previous sales and earnings guidance for the fiscal year ending September 30, 2010. This action is being taken as a result of weaker than expected operating results for the second quarter ending March 31, 2010, based on preliminary results to date. Separately, Meridian announced that it will file a 510(k) for FDA marketing clearance next week in connection with its illumigene™ C. difficile product.

17 Mar 2010

Roche Diagnostics named sole source supplier for Premier's blood glucose monitoring devices

Roche Diagnostics announced today that it has been awarded contracts for blood glucose monitoring and clinical chemistry/immunoassay lab analyzers from Premier Purchasing Partners, L.P., Inc., the group purchasing unit of Premier, Inc. Roche was also named the sole source supplier for blood glucose in Premier's exclusive ASCEND supply chain performance program.

From Roche Sequencing and Life Science 16 Mar 2010

BG Medicine, Merck collaborate in development of novel biomarker for lipid disorder management

BG Medicine, Inc. today announced that it has entered into a research collaboration with Merck, through a subsidiary, for the development and validation of a novel biomarker with potential application in the management of lipid disorders. BG Medicine will pursue development and validation of an immunoassay and investigate its clinical utility as a biomarker. If successful, BG Medicine plans to complete the development and validation studies and seek regulatory clearance for the test.

18 Feb 2010

Fourth-quarter and full-year 2009 results announced by Quidel

Quidel Corporation, a leading provider of rapid point-of-care diagnostic tests, announced today financial results for the fourth quarter and full year ended December 31, 2009.

12 Feb 2010

Abbott seeks U.S. approval for HE4 assay to monitor recurrence/progression of epithelial ovarian cancer

A new diagnostic tool physicians can use to monitor patients for the most common form of ovarian cancer may soon be available in the United States. Abbott's ARCHITECT HE4 assay uses a simple blood test to help in monitoring for the recurrence or progression of epithelial ovarian cancer. If approved, this important immunoassay would be the first automated HE4 test available in the United States.

9 Feb 2010

Polymedco's automated immunoassay fecal occult blood test system receives FDA clearance

Polymedco, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance of the OC-Sensor Diana, a high throughput automated system for the immunoassay fecal occult blood test (FIT) used for detecting gastrointestinal bleeding associated with disorders such as colorectal cancer, polyps and colitis.

5 Feb 2010

NanoInk launches configured protein array kit from its Nano BioDiscovery Division

NanoInk, Inc.®, a global leader in nanotechnology, is pleased to announce the launch of its first completely configured protein array kit from its Nano BioDiscovery™ Division. Based on the patented Dip Pen Nanolithography® (DPN®) platform, NanoInk's fluorescent assays enable nanoscale detection of clinically relevant proteins.

2 Feb 2010