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The 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.
Cepheid received the CE Mark for Xpert MRSA (Methicillin-resistant Staphylococcus aureus) test for clinical diagnostic use on the GeneXpert System. Clinical Data Inc. signed an exclusive worldwide license to a portfolio of patents related to a variation in the Fc gamma receptor IIIA gene. Clinical Data will develop a pharmacodiagnostic test for response to rituximab (Rituxan by Genentech/Biogen-Idec and Mabthera by Hoffmann-La Roche) in the treatment of non-Hodgkin's Lymphoma. eGene introduced an automated HLA SSP genotyping system. The test is expected to replace slab gel electrophoresis methods and digitalize data management. Epigenomics is developing biomarkers for lung cancer screening based on DNA methylation. Gen-Probe introduced a number of new tests. The company received FDA clearance to market the Procleix Ultrio Assay to run on the Procleix System (eSAS). The assay was approved to screen donated blood, plasma, organs and tissue for HIV-1 and HCV in individual blood donations or in pools of up to 16 blood samples, and to detect the presence of HBV, outside the U.S. in 2004. Gen-Probe also received FDA approval for the Aptima HIV-1 RNA qualitative assay. The assay is the first FDA-approved qualitative nucleic acid test for the diagnosis of HIV infection. Aptima assays for Chlamydia trachomatis and Neisseria gonorrhoeae were FDA approved for use on TIGRIS system. Meridian Bioscience entered into a license agreement with Eiken Chemical Co. for its LAMP (Loop-mediated Isothermal Amplification) technology. The license allows Meridian to apply the LAMP technology for the detection of infectious diseases in the United States and 18 other geographic markets. Qiagen acquired all outstanding shares of Genaco Biomedical Products, an early-stage company applying a proprietary PCR-based multiplexing technology, Tem-PCR, to develop Templex molecular diagnostic tests.
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