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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 November 2005
Dear Reader, I would like to take this opportunity to thank you for your loyalty and to wish you and your families joy and health in this holiday season and peace to us all in the new year. Shara Rosen Baxter Healthcare Corporation received FDA clearance to market seven day storage of leukoreduced, apheresis platelets collected on the AMICUS Separator and stored in Baxter's PL 2410 collection container. This clearance will allow for the transfusion of these platelets when coupled with 100% release testing for bacterial contamination using the bioMerieux BacT/ALERT Microbial Detection System. The traditional shelf life is five days. Bayer HealthCare, Diagnostics Division, a member of the Bayer Group and Inverness Medical Innovations, Inc. signed four product agreements to be marketed by Bayer. The first is for a POC assay for B-type Natriuretic Peptide (BNP) to be marketed worldwide, except Japan. The second grants Bayer an option to commercialize Inverness' proprietary Urotensin marker on its automated immunoassay systems worldwide. The third agreement calls for Inverness and Bayer to work together in developing an application of the Inverness Ischemia Modified Albumin (IMA) test for worldwide use on Bayer's automated ADVIA chemistry analyzer. The final agreement grants Bayer non-exclusive rights to an Inverness hybridoma cell line capable of producing monoclonal antibodies against the envelope protein of the Hepatitis B virus (HBe). Bayer HealthCare, Diagnostics Division, a member of the Bayer Group launched the ADVIA Centaur CP Immunoassay System, a benchtop, fully automated analytical system. Bio-Rad Laboratories, Inc. received FDA clearance to market its Medical Decision Support Software (MDSS) designed for use with the company's FDA cleared BioPlex 2200 ANA Screen and BioPlex 2200 System. The interpretive algorithm-based software correlates patient antibody results with specific autoimmune diseases. Biolytical Laboratories' POC Insti HIV test was approved for market by Health Canada for professional use only. The company is investigating regulatory approval in China, India, eastern Europe and sub-Saharan Africa. Biolytical also intends to begin seeking FDA approval in late 2006. Calypte Biomedical Corporation sold its legacy urine EIA, serum Western Blot and urine Western Blot HIV-1 in vitro diagnostic test business to Maxim Biomedical, Inc. The sale is the final step in the restructuring plan to focus the company's efforts on its rapid and blood-based test products. Cholestech Corporation and Boule Diagnostic International are collaborating on the development of a POC, CLIA waived Complete Blood Count (CBC) test system. Cholestech will receive exclusive distribution rights covering all human applications in the US and Canada. Cholestech anticipates commercializing the CBC system in 2007. Instrumentation Laboratory GmbH introduced the Multiplate platelet function analyser to assesses effects of the anti platelet drugs Aspirin, Plavix and Reopro within 10 minutes using whole blood. The instrument allows parallel testing in 5 channels.
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