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 2001Bayer Corporation has acquired the exclusive worldwide rights for the sale and marketing of Innogenetics' LiPA HIV and LiPA HCV products and their future generations. Innogenetics will be responsible for the research, development and manufacturing of the existing products and their future generations over the term of the agreements. The products covered by the agreement include a test for HCV genotyping and a line of HIV drug resistance assays. As of April 2001, Beckman Coulter, Inc. will assume U.S. distribution responsibilities for all IL Test hemostasis test kits from Fisher Healthcare. In North America, Beckman Coulter already is the exclusive distributor of ACL analyzers, ELECTRA-brand coagulation analyzers and the Hemoliance product line. Bioenergy Inc. has launched a new company ViaCyte, LLC, that will produce products extending the life and viability of blood platelets and other cells for transplant or transfusion. The product for storing platelets is a solution that includes D-ribose in optimal concentrations to keep platelets in their resting state during storage, to control spontaneous activation and to have more viable cells available at the time of transfusion. Bio-Rad Laboratories, Inc. has renewed a collaboration agreement with the Institut Pasteur for an additional four years. This represents a continuation of a cooperative relationship that dates back to 1990 and gives Bio-Rad exclusive commercialization rights to Pasteur's research developments in the areas of virology, microbiology, physiology, biochemistry, parasitology and mycology. The Centers for Disease Control and Prevention has selected OraSure Technologies Inc.'s OraQuick HIV-1/2 rapid HIV test for use in its sponsored Treatment Investigational Device Exemption. The CDC will use the test in public hospitals in five Metropolitan areas with relatively high HIV seroprevalance among pregnant women and in AIDS service organizations, community based organizations, and outreach programs. Cerus Corporation has been awarded a $3.5 million cooperative agreement by the Army Medical Research Acquisition Activity division of the Department of Defense to develop its pathogen inactivation technologies to improve the safety and availability of blood that may be used by the Armed Forces of the United States for medical transfusions. The company's Helinx technology and Intercept Blood Systems are designed to target and lock DNA or RNA, and has the ability to prevent the replication of viruses, bacteria and other pathogens and to control cellular proliferation. Chiron Corporation and Gen-Probe Incorporated have developed Chiron's Procleix HIV-1/HCV Assay. The assay is a nucleic acid amplification test designed to detect the presence of HIV-1 and HCV in whole blood and plasma during the earliest stages of infection. Outside of North America, the Chiron Procleix HIV-1/HCV System is available for commercial sale and is undergoing evaluation in countries within Europe, Asia/Pacific, South America, and Africa. ChromaVision Medical Systems, Inc., manufacturer of the ACIS system, has entered into an agreement with Antibodies Incorporated that enables the company to market customized reagents and antibody kits together with its cellular imaging system. The two companies will collaborate to develop products that complement current and future ACIS applications to provide a complete slide-based testing system. The initial project is underway to create a ChromaVision ACIS kit for the detection of cytokeratin positive cells to help physicians identify and analyze cancer micrometastasis. Dade Behring has received FDA clearance to market the Dimension Expand Analyzer designed for low volume testing laboratories. The system offers more than 70 methods including TDMs, immunoassays, plasma proteins, DAUs and other chemistries. diaDexus has been issued a U.S. patent covering a method for the diagnosis of a patient's susceptibility to atherosclerosis using antibodies against Lp-PLA2. Lp-PLA2, an enzyme associated with atherosclerotic plaque, was discovered by SmithKline Beecham scientists. CytImmune Sciences Inc. and EntreMed have developed an Endostatin Immunoassay Kit. Endostatin levels are detectable in serum from both healthy subjects and those with metastatic clear cell renal carcinoma (CCRC). The researchers reported that serum Endostatin levels are significantly increased in patients with metastatic CCRC as compared to an age-matched group of healthy volunteers. York Nutritional Laboratories, Inc. has launched FoodSCAN a home food allergy test. Patients prick the end of their own finger to collect a sample of blood which is analyzed in York's labs. IMI International Medical Innovations Inc. has signed a license agreement with Procyon BioPharma Inc. to acquire rights to Procyon's colorectal cancer screening technologies. IMI receives an exclusive worldwide license to develop, market, distribute and sublicense Procyon's COLOPATH technology. COLOPATH is a mucus-based test that is believed to be suitable as a point-of-care test. Matritech, Inc. has entered into a non-exclusive product supply and marketing agreement with Diagnostic Products Corporation whereby DPC will develop and market an automated version of Matritech's NMP22 test kit for bladder cancer. The NMP22 test will be incorporated for use on DPC's IMMULITE and IMMULITE 2000 systems. Worldwide Medical Corp., marketer of FIRST CHECK home screening tests for drugs of abuse, alcohol and colorectal disease has entered into an e-commerce marketing and distribution agreement with WebRx.com - HealthCentral.
Product developments - February 2001
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