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 January 2004
Abbott Laboratories has entered into a worldwide distribution agreement with Atria Genetics, Inc., (now known as Forensic Analytical/Molecular Genetics) for a line of tests for defining human leukocyte antigens (HLA) used for identifying potential donors in the matching process for bone marrow transplantation.
AcroMetrix has acquired the ViroSure product line previously manufactured by Nabi Biopharmaceutical's antibody business and other assets related to its diagnostics business. AcroMetrix obtains Nabi's FDA approved ViroSure Multi-Marker quality control products for use in blood testing laboratories. ViroSure is one of only two quality control products for Hepatitis and HIV that are FDA approved for use in blood testing laboratories.
Beckman Coulter, Inc. has received FDA clearance to market its Access GI Monitor CA 19-9 test used in the management of pancreatic cancer. Beckman has also signed an exclusive, worldwide technology licensing agreement with InPro Biotechnology for InPro's CDI-5 immunoassay used to diagnose bovine spongiform encephalophy (mad cow disease). The test will be made available on Beckman Coulter's Biomek automation platform and will be marketed initially to customers in Europe, Japan and North America.
Biosite Inc. has received FDA clearance to market the Triage BNP Test for use with capillary whole blood.
Cepheid and bioMerieux have entered into a collaboration whereby bioMerieux will develop DNA testing products using its NASBA (Nucleic Acid Sequence-Based Amplification) technology to be run on systems employing Cepheid's Smart Cycler and GeneXpert platform technologies.
Chiron Corp has licensed Infectio Diagnostic Inc.'s (IDI) nucleic acid-based technology for the rapid detection of bacterial contamination in platelets and blood products. Under the terms of the agreement, Chiron will obtain a license to all current and future products for the detection of bacteria in platelets and blood for transfusion based upon the technology. In addition, IDI will transfer the technology including R&D and manufacturing to Chiron over the next two years. Chiron has also formed a partnership to develop and commercialize ZymeQuest's enzymatic conversion system, which converts groups A, B and AB red blood cells to enzyme-converted group O (ECO) red blood cells. Under the terms of the agreement, Chiron will share in the costs of developing and commercializing the enzymatic conversion system.
Cytyc Corp. and Abbott Laboratories are collaborating to develop and market a bladder cancer screening test. Cytyc will modify its ThinPrep UroCyte slide preparation system to work with Abbott's UroVysion test. The system will detect bladder cancer by identifying chromosomal abnormalities using DNA probes.
Gen-Probe Incorporated has received FDA clearance to market the APTIMA Vaginal Swab Specimen Collection Kit, that enables patients to self-collect vaginal swab specimens to be tested for Chlamydia trachomatis and Neisseria gonorrhea using the APTIMA COMBO 2 assay.
Glucon is developing a non-invasive, continuous, accurate, and real-time blood glucose monitoring for clinical and personal use, based on the company's photoacoustics technology that enables direct measurement of glucose levels from within blood vessels.
Paradigm Genetics, Inc. has acquired TissueInformatics. Inc a company that specializes in the development and application of automated pathology software for the quantitative analysis of tissue changes in drug discovery, disease assessment, toxicology, and tissue engineering. The acquisition will occur through an all-stock transaction in which approximately 3.4 million shares will be issued immediately and approximately 2.7 million additional shares are subject to performance milestones.
Pfizer Inc. has agreed to sell the Pharmacia diagnostic testing business to two private equity firms (Triton, a European private equity firm, and PPM Ventures Ltd., the private-equity subsidiary of Britain's Prudential PLC, ) for $575 million. Pharmacia makes blood test systems which are used in the clinical diagnosis and monitoring of allergy, asthma and autoimmune diseases.
Prometheus Laboratories Inc., has introduced FIBROSpect II, a diagnostic panel to aid in the detection of liver fibrosis in patients with chronic hepatitis C. The blood test helps physicians differentiate the presence of no/mild from significant liver fibrosis without the need for a liver biopsy. FIBROSpect II is based on three extracellular matrix remodeling proteins utilizing an analysis.
Sysmex America Inc. has formed a partnership with Bio-Reference Laboratories, Inc. to develop the advanced capabilities found on Sysmex hematology systems into new test parameters for hematology and oncology.
Product developments - December 2003
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Last modified: February 2, 2004