The following is a review of diagnostic product developments worldwideThe information is updated the first week of every month - so ... make this a regular stop in your information gathering activities.
The following information has been compiled from publicly available sources, StratCom does not assume any responsibility for the accuracy or the authenticity of the information and StratCom cannot be held liable for errors.
Product developments in May 2006
Dear Reader, the summer is upon us (if it ever stops raining) and it’s time to take a bit of a respite. So this is the last posting until September 2006. See you then. Have a happy and safe summer, Shara Rosen
Abbott Labs entered into a licensing agreement with Advanced Life Science Institute, Inc. for its Pro-gastrin-releasing peptide (ProGRP). ProGRP is a biomarker that may assist clinicians in diagnosing and monitoring small cell lung cancer. Currently, no diagnostic test is approved in the U.S. for testing serum for lung cancer.
Aureon Laboratories received FDA clearance to market the Prostate Px test that combines multiple scientific disciplines (cellular, molecular and clinical information about a patient with advanced computer technology and digital imaging) can predict accurately which men are either at high or low risk for a return of cancer after surgical removal of the prostate gland. The biopsied tissue test, performed at the Aureon lab provides a Prostate PX Score and is priced at $1,968.
bioMerieux sold its hemostasis range of products to Trinity Biotech plc. The product line includes the MDA, MTX and Thrombolyzer platforms, as well as a comprehensive menu of reagents to analyze blood clotting parameters.
Biophage Pharma launched an R&D program with Héma-Québec for the evaluation of the potential use of the PDS biosensor for the detection of bacterial contamination in standard platelet concentrates.
Chembio Diagnostics received FDA clearance to market for its SURE CHECK HIV 1/2 and HIV 1/2 STAT-PAK rapid test for professional use.
The PGxHealth division of Clinical Data is developing a commercial genetic test for clozapine-induced agranulocytosis (CIA). The gene is located in the HLA complex, an area associated with CIA. Clozapine is one of the most effective medications available for treating schizophrenia, but its use is limited because of the risk of inducing agranulocytosis, a potentially fatal blood disorder. Clinical Data is continuing to work on identifying other biomarkers related to CIA, and is investigating agranulocytosis and neutropenia induced by other drugs.
Inverness Medical Innovations acquired 49% of the capital stock of TechLab in exchange for 303,417 shares of Inverness common stock. The transaction provides Inverness, whose Wampole subsidiary already distributes TechLab's products in the United States, with exclusive global distribution rights to TechLab's market leading line of enteric disease testing products, as well as future human medical diagnostic products, as Techlab's existing global distribution relationships lapse.
Nova Biomedical introduced the Nova StatStrip point-of-care glucose monitor using four well glucose measuring strip technology. The system measures and corrects hematocrit interference as well as interferences from oxygen, acetaminophen, uric acid, ascorbic acid, maltose, galactose, xylose, and lactose.
Nymox Pharmaceutical was awarded CE Mark for its saliva-based version of its NicAlert product for testing for tobacco use or exposure.
Perceptronix Medical was awarded CE Mark for its ClearSign Sputum Test for the detection of lung. Perceptronix will offer the test in Canada and Europe to be performed at the company’s Quantitative Cytology Laboratory. The test is indicated for subjects who are suspected of having lung cancer due to their high risk smoking or industrial carcinogen exposure.
Roche Diagnostics was awarded CE Mark for the cobas TaqScreen MPX, a PCR test that detects HIV-1 groups M and O, HIV-2, and hepatitis B and C. It replaces three separate PCR-based nucleic acid tests, which detect only HIV-1, and Hepatitis B and C. The test is designed to run on the new cobas 201 system.
Siemens Medical Solutions and Diagnostic Products Corporation (DPC) entered into a merger agreement under which Siemens will acquire DPC for approximately $1.86 billion.
Thermo Electron and Fisher Scientific agreed to merge. The new company will be named Thermo Fisher Scientific Inc. and is expected to have more than $9 billion in revenues and $1 billion in cash flow in 2007.
Ventana Medical Systems announced the commercial launch of its fully automated Symphony H&E, or primary staining system for use in clinical histology and drug discovery laboratories.
Product developments - April 2006
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Last modified: June 6, 2006