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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 September 2005
American Scientific Resources has begun US distribution of urinalysis instruments and reagents from Analyticon. The main product is the Combi Scan S, a portable, battery operated urine analysis instrument used with a detachable docking station for use in satellite laboratories, by visiting nurses and insurance examiners. Biosite Inc. has received FDA clearance to market a new indication for its Triage BNP Test. The test can now be used to assess the risk of mortality or rehospitalization in heart failure patients. Previously, the test was cleared as an aid in the diagnosis of congestive heart failure, assessment of disease severity and in the risk stratification of patients with acute coronary syndromes. Dade Behring Holdings, Inc. is planning to acquire certain medical diagnostic assets from Ranbaxy Laboratories. The acquisition is an extension of Dade Behring's and Ranbaxy's current partnership that allows Ranbaxy's India-based customers to purchase Dade Behring's portfolio of products and services. IBEX Technologies Inc. released for sale its assay for human kallikrein 6 (hK6) for ovarian cancer (for research use only). IBEX previously released hK10, another ovarian cancer assay for research purposes, in September 2004. Preliminary studies have indicated that hK6 enhances the detection capability of the approved ovarian cancer assay CA-125. Ibex is working with a number of multinational diagnostic companies to explore the use of hK6 and other kallikrein assays in high throughput clinical diagnostic systems. Inverness Corp. intends to acquire Thermo Electron Corp's Thermos Biostar Point of Care and Rapid Diagnostics business for $52.5 million in cash. The closing of the acquisition is subject to Inverness obtaining the consent of its lenders, and to other ordinary and customary closing conditions. Medical Home Products, Inc. signed a distribution agreement with Polymer Technology Systems to distribute the CardioChek System, a home test for HDL and LDL cholesterol, triglycerides, glucose, and ketones. The National Center for Genome Resources was awarded $2.7 million by the National Institute of Allergy and Infectious Disease to develop novel diagnostic tests for severe sepsis and community acquired pneumonia under the Community Acquired Pneumonia & Sepsis Outcome Diagnostics (CAPSOD) program. CAPSOD is a five-year program that will prospectively enroll patients with sepsis and CAP at Duke University Medical Center and Henry Ford Hospital. The study will use advanced bioinformatic and proteomic technologies to identify specific protein changes, or biomarkers, in patient blood samples that predict outcome in sepsis and CAP. Quidel Corp. acquired the immunochemical Fecal Occult Blood Test (iFOBT) from Alfa Scientific Designs, Inc. The test will be marketed as the QuickVue iFOB test. MDS Sciex introduced the CellKey System that measures endogenous cell surface receptor activation in live cells and generates data that enables identification of the receptor coupling mechanism of unknown receptors (for example, orphan G protein-coupled receptors, GPCRs). The CellKey System uses impedence-based cellular dielectric spectroscopy technology, an approach that removes the requirement for fluorescent or radio-labeled markers. ViroLogic, Inc. announced that it is changing its name to Monogram Biosciences, Inc. The company stated: "Our new name reflects our broader commitment to extend our pioneering efforts in individualized medicine beyond viral diseases and into oncology and other serious diseases."
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