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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

Roche to present diagnostics testing solutions at 2010 Clinical Lab Expo

Roche is featuring a diverse portfolio of diagnostics testing solutions for healthcare professionals in booth #2808 at the AACC/CSCC 2010 Clinical Lab Expo here, July 27-29 – and it's giving them a unique way to see firsthand where their own "dream lab" might take them.

From Roche Sequencing and Life Science 28 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

FDA clears Meridian Bioscience's new illumigene C. difficile molecular amplification assay

Meridian Bioscience, Inc., Cincinnati, Ohio today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its new molecular amplification assay, illumigene™ C. difficile. Clostridium difficile is a bacterium that can cause diarrhea and, in severe cases, a life-threatening inflammation of the colon.

14 Jul 2010

USPTO grants Vermillion Alzheimer's disease biomarker patent

Vermillion, Inc., a molecular diagnostics company, today announced that the United States Patent and Trademark Office (USPTO) has issued a notice of allowance of a patent entitled "Biomarkers for Alzheimer's disease" to the Company.

29 Jun 2010

Claros point-of-care system for PSA receives European CE Mark approval

Claros Diagnostics, a developer of novel point-of-care in vitro diagnostic systems, today announced the CE Mark approval for its rapid quantitative point-of-care diagnostic platform, which can now be used for prostate specific antigen (PSA) testing throughout the European Union. The approved system consists of a small portable analyzer and credit card-sized disposable.

29 Jun 2010

CardioGenics announces clinical test sites for QL Care portable blood analyzer

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 the selection of four sites for clinical testing of its patented QL Care™ Analyzer, a portable diagnostic platform designed to produce test results with central lab-like accuracy in 15 minutes using whole blood.

21 Jun 2010

FDA approves Abbott's ARCHITECT HIV Ag/Ab Combo assay

Every nine and a half minutes, someone in the United States is infected with HIV, and one out of every five of these individuals doesn't know it. To help stem the spread of this disease, the U.S. Food and Drug Administration (FDA) today approved an innovative new diagnostic tool, which will allow patients to be diagnosed earlier than ever before.

21 Jun 2010

CardioGenics Holdings files Certificate of Change with the Secretary of State of Nevada

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 that the Company has filed a Certificate of Change with the Secretary of State of Nevada, which implements a share consolidation of the Company's authorized and outstanding common stock on a ten (old) for one (new) basis.

19 Jun 2010

MicroConstants adds second Waters Xevo TQ MS system

MicroConstants, Inc., a bioanalytical and pharmacokinetic-specialty Contract Research Organization (CRO) in San Diego, California, announces the continued expansion of its bioanalytical capacity through the addition of a second Waters Xevo TQ MS system. The CRO has also appointed a new East Coast business development manager to actively pursue new business opportunities in that region.

10 Jun 2010

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.