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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 February 2000Accumetrics, Inc. has launched the marketing of its FDA approved Ultegra System to measure platelet function in patients undergoing coronary interventional procedures. The Ultegra System will provide cardiologists with a tool to assess platelet function at the bedside from a whole blood sample in less than two minutes. Bio-Rad Laboratories, Inc. has been selected by France's Commissariat a l'energie atomique or CEA, to produce and market an immunoassay for BSE (Bovine Spongiform Encephalopathy) or Mad Cow Disease. Industrialization of the product is underway, with epidemiological studies soon to begin. Bio-Rad has a worldwide exclusive option right on the test's intellectual property, which is owned by the CEA. IDS Intelligent Detection Systems Inc.'s business unit, Caduceon, is developing a point-of-care breath analysis unit for application in the clinical, lifestyle and occupational health markets. The device adapts gas chromatography for non-invasive screening and monitoring of conditions such as asthma, neonatal blood disorders, breast cancer, and lung cancer. CME Telemetrix Inc., has formed a strategic relationship with Motorola Inc. whereby Motorola acquires a worldwide exclusive license for CME's non-invasive medical devices for measuring glucose and other diabetes related analyses. With a global partner like Motorola, CME gains access to strong international marketing and world-class manufacturing, critical for the commercial launch of its non-invasive glucose monitor. Diagnocure has developed the uPM3 urine test for early detection of prostrate cancer. The test proves detects a gene maker of prostrate cancer in urine. The company anticipates to market the test in 2001. Hemagen Diagnostics Inc. has signed a long-term agreement to provide reagents and diagnostic kits to Roche Diagnostics Corporation The agreement covers thirty immunoassay products manufactured by Hemagen's Raichem division. i-STAT Corporation has received FDA clearance to market its celite ACT activated clotting time test used in cardiovascular surgery, cardiac catheterization labs and other critical care settings to monitor patients on heparin therapy. Spectral Diagnostics Inc. has entered into a non-exclusive technology license and access agreement with Beckman Coulter Inc. for the company's troponin I calibrator materials and technology for use on Beckman's Access Immunoassay System. Vysis Inc. has begun marketing its GenoSensor Microarray System designed to simultaneously detect chromosomal amplifications or deletions of multiple genes in various human cancers. The GenoSensor Microarray System includes genomic microarrays, reagents, instrumentation and analysis software. The first commercially available microarray, the AmpliOnc I, detects abnormal increases in gene copy number from 58 different genes. Other microarrays will be developed that detect chromosomal aberrations in pre and post-natal applications.
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