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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 March 2004
Abbott Laboratories and Europroteome AG have entered into a research collaboration for the discovery and development of in vitro diagnostic tests for the early detection of breast cancer for use on Abbott's automated instrument systems. Abbott Laboratories has acquired non-exclusive rights to Corixa Corporation's recombinant TcF antigen for potential use in the development of a blood screening test to detect antibodies to Trypanosoma cruzi. T cruzi causes Chagas' disease. Axis-Shield received FDA clearance to market its radioimmunoassay for holoTC, a patented test for the measurement of biologically-available vitamin B12, or holo-transcobalamin. Malabsorption of vitamin B12 is a major problem that can be associated with neurological damage and Alzheimer's disease. Measurement of B12 using conventional assays may not detect low level deficiency of this important vitamin. Beckman Coulter, Inc. signed an exclusive licensing agreement with Research and Diagnostic Antibodies LLC for R&D Abs' inducible nitric oxide (iNOS) monoclonal antibodies and patents. iNOS is a new marker in blood that may be used for the detection and management of patients at risk for developing sepsis. Beckman Coulter intends to develop iNOS tests for use on all Beckman Coulter Access systems. The company hopes to introduce these tests in 2005. Bio-Rad Laboratories, Inc. purchased the majority of assets of Hematronix Inc. Bio- Rad will acquire the company's line of quality control products and services. BioPredictive has licensed to LabCorp, its HCV FibroSURE, a noninvasive blood test for assessing liver status in hepatitis C virus patients. HCV FibroSURE is used to assess liver fibrosis and necroinflammatory activity in HCV patients, based on a combination of six serum biochemical markers plus age and gender in a patented algorithm. Biosite Incorporated entered into a license and collaboration agreement with DMI BioSciences, Inc. to develop an immunoassay forcysteinylated albumin (cys-albumin), a biomarker that is elevated in blood when a patient is undergoing ischemia. Biosite obtained certain exclusive and semi-exclusive diagnostic rights to the biomarker, together with specified sublicensing rights. Dade Behring granted a non-exclusive sublicense to Roche Diagnostics for the development, manufacture and marketing of a high sensitivity C-reactive protein immunoassay for cardiovascular risk assessment. DakoCytomation A/S acquired exclusive worldwide rights to develop and commercialize pharmacogenomic diagnostic tests in the field of oncology based on the TRAIL Receptor-1 (TRAIL-R1) and TRAIL Receptor-2 (TRAIL-R2) proteins developed by Human Genome Sciences, Inc. Fisher Scientific International Inc. is planning to buy Apogent Technologies Inc. for $2.68 billion in stock. Generex Biotechnology Corporation's wholly-owned subsidiary, Antigen Express, is working to develop a diagnostic kit for the early detection and screening of Type 1 diabetes in young children. The studies will focus on the role that Lymphocytes (T-cells) play in a series of pancreatic antigens, the most common of which are GAD (glutamic acid decarboxylase), IAA (tyrosine phosphatase) and IA (insulin). OraSure Technologies Inc. received FDA clearance to market its OraQuick HIV-1/2 test, a rapid, point-of-care test for use with oral fluid, fingerstick and venipuncture whole blood, and plasma samples. The OraQuick HIV-1/2 test had received prior FDA approval for use in detecting antibodies to both virus types in finger stick and venipuncture whole blood samples. OraSure is seeking a license to certain HIV-2 patents held by Bio-Rad Laboratories. Rapid Bio Tests Corporation entered into an agreement with Dr. Michael Huchital of Warwick, New York to acquire all rights, interests and title to a portfolio of rapid infectious disease diagnostic tests for Hepatitis B virus, Bubonic Plague, Mad Cow Disease, Rabies Virus, West Nile Virus, four strains of Malaria, Whooping Cough, Chagas' disease, Tuberculosis, Clostridium Botulinum toxin and Ricin toxin. Spectral Diagnostics Inc. is developing a line of rapid diagnostic tests for infectious diseases, including West Nile Virus. Sysmex America, Inc. received FDA clearance to market its Body Fluid application on their XE-2100 Series Automated Hematology Analyzers. Automated Body Fluid analysis can now be performed on cerebrospinal fluid, serous and synovial fluids using Sysmex systems. No specimen preparation is need before sample analysis.
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