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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 2002
Abbott Laboratories and the University of Zurich, Switzerland have entered into a non-exclusive licensing agreement and a research collaboration for the development of in vitro diagnostic tests for neurodegenerative diseases related to the presence of abnormal prion proteins in humans and animals. Beckman Coulter will incorporate Axeda DRM technology as part of its PROService program, the company's automated instrument monitoring and proactive troubleshooting service. Axeda Systems' Device Relationship Management (DRM) software will be used on the COULTER LH 700 hematology line. The Axeda DRM system enables Web transmission of instrument data - such as temperature, voltage, calibration and other events - and alerts service representatives if an instrument is operating outside preset performance standards. Cavro Scientific Instruments, Inc announced that effective March 15, 2002, the company is changing its name to Tecan Systems. Operating as Cavro Scientific Instruments, Inc., since 1972, the company was purchased as a wholly owned subsidiary of the Tecan Group in 1987 Corixa Corporation and the Advanced Diagnostic and Cellular Systems division of Ortho-Clinical Diagnostics have formed an exclusive collaboration to develop molecular diagnostic tests for breast cancer based on several of Corixa's proprietary genes. The FDA's Microbiology Devices Panel has recommended that the FDA approve, with conditions, Digene's Pre-Market Approval Supplement application that enables Digene to market its Hybrid Capture 2 HPV DNA Test, in conjunction with the Pap test, as a primary screening test for cervical cancer and its precursors in women age 30 and over. Diagnostic Products Corporation has signed an agreement with Medical Electronic Systems Ltd providing DPC exclusive distribution rights for the MES SQA-V sperm analyzer in the US, Puerto Rico, Canada and Brazil. The SQA-V uses electro-optics, computer algorithms and video microscopy to provide rapid and reliable semen analysis in less than 75 seconds. Fujirebio Diagnostics has acquired the rights to develop and commercialize cancer diagnostic tests based on the cancer-specific gene survivin from Yale University. The survivin gene is specifically expression in tumor tissues. Survivin has potential use as a diagnostic test for bladder cancer. Great Smokies Diagnostic Laboratory has launched a new product line of predictive genomic tests to complement its full range of metabolic assessments in the field of preventive medicine. The new genomic line, called Genovations, applies recent breakthroughs in genetic research driven by the Human Genome Project to provide clinical assessment tools for primary care physicians. IVAX Diagnostics has acquired the assets of Sigma Diagnostics' global enzyme immunoassay product line. The companies are currently negotiating definitive agreements and, if successful, plan to consummate the transaction during the second quarter. Sigma Diagnostics currently markets EIA instruments and reagents throughout the world including products purchased from IVAX Diagnostics. As a consequence of the acquisition, IVAX Diagnostics will no longer sell reagents or instrumentation to Sigma Diagnostics, which was its largest customer for the past three years, but will market and sell the products directly. Johnson & Johnson has acquired all of the assets of Tibotec-Virco NV. The transaction is valued at approximately $320 million in cash and debt. LabCorp has introduced a suite of molecular assays developed to improve the management of patients diagnosed with the hepatitis B and/or hepatitis C virus. Hepatitis C QuantaSure is a viral load test capable of detecting hepatitis C virus down to as few as 2 IU/mL. LabCorp will soon introduce the HCV QuantaSure Plus test which is performed using TaqMan real time PCR. HBV SuperQuant allows for the measurement of HBV viral loads in the range of 100 - 5 billion copies/mL. The Hepatitis B GenoSure resistance test is capable of detecting all of the currently known mutations that contribute to HBV drug resistance. LifeScan and Novo Nordisk A/S have received FDA clearance to market the InDuo System, a new device that combines blood glucose monitoring and insulin delivery into one compact device. MedicGroup is developing a saliva test for breast tumor marker tumor marker c-erbB-2 (HER2/neu). MedicGroup hopes to apply to the FDA for approval for the test by the end of 2002 and to have the test on the market by the end of 2003. Milagen has developed ANTIBIOMIX, a process to generate antibodies to virtually all proteins and living organisms. The company reports it has generated more than 61,000 antibodies to human genes and is set up to possibly generate antibodies to all human proteins. Milagen expects to have between 80,000-100,000 by the end of the year 2002. They are developing innovative products for therapeutic and diagnostic applications based on these large antibody collections. Molecular Diagnostics is developing the patented InPath PCD (Personal Collection Device), a personal cervical cell collection device. The device is currently in trials in China as part of a broad study being managed in conjunction with the Cleveland Clinic Foundation, and the Beijing Cancer Institute. The device, after collection of a sample, is deposited in a liquid preservative for transport to a laboratory for analysis. Testing options include the company's proprietary In-Cell HPV and Cocktail CVX assay, as well as conventional Pap testing, HPV DNA testing, Gonorrhea, Chlamydia, and other molecular tests. Myriad Genetics has formed a drug discovery collaboration with Abbott Laboratories to identify novel genes and drug targets for the diagnosis and treatment of depression. Ortho-Clinical Diagnostics has acquired Micro Typing Systems. MTS is now a wholly owned subsidiary of Ortho-Clinical Diagnostics, Inc. MTS manufactures the ID-Micro Typing System used to type blood for transfusion. Quest Diagnostics has introduced an improved version of its HEPTIMAX hepatitis C viral load test using Roche Diagnostics' COBAS TaqMan platform. The HEPTIMAX HCV has a test range of 5-50 million IU/mL and uses Bayer's TMA technology available through Bayer's exclusive agreement with Gen-Probe. Ribozyme Pharmaceuticals and Fujirebio Diagnostics are collaborating to develop ribozyme-based clinical diagnostic products. Under terms of the agreement Fujirebio will receive exclusive commercialization rights for East Asia, including Japan, for any resulting products from this collaboration.
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