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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 April 2005
Abbott Diagnostics and Axis-Shield received FDA clearance to market an automated sirolimus test for monitoring the therapeutic levels of Wyeth's anti-rejection drug RAPAMUNE in whole blood on Abbott's IMx System. The assay uses Microparticle Enzyme Immunoassay (MEIA) technology. Bedfont Scientific, has developed the Smokerlyzer carbon monoxide breath test, a tool that can aid parents in testing their kids for cigarette and marijuana use. Carbon monoxide is a component of both cigarette and marijuana smoke, and there are discernible differences between both substances because of the different way in which they are smoked. The device has been commercialized in the form of a personal breath tester for $59.99. BioGenex has introduced Xmatrx, a walk-away system for cell and tissue staining applications for use in drug research and development. The system is designed to automate all assay steps required to perform Fluorescence In Situ Hybridization (FISH), In Situ Hybridization (ISH), and Immunohistochemistry (IHC), including the application of cover-slip, resulting in a completely finished slide that is ready to go directly on a microscope for review or by digital image analysis. bioMerieux announced that its BacT/ALERT 3D Microbial Detection System will play an integral role in Gambro's Single Donor Platelet Technology system. Gambro BCT, Inc., recently received FDA clearance for apheresis platelets to be collected with its Trima and COBE Spectra Collection Systems. Clearance was obtained on the condition that the platelets are tested with the bioMerieux BacT/ALERT Microbial Detection System, and used as described in the Gambro BCT seven-day platelet protocol. The FDA clearance will now allow blood banks that use the Gambro BCT system to store single donor platelets for up to seven days instead of five days. Biomoda Inc. is developing the CyPath assay for cancer that can differentiate lung cancer patients, heavy smokers and normal individuals. This is a cytology assay with the ability to differentiate normal cells from abnormal cells. CyPath's initial cancer target is lung cancer; additional R&D is focused on addressing bladder and cervical cancers. Biophage Pharma Inc. is developing a Biosensor unit is now able to detect the three most important bacterial pathogens in drinking water : E. coli 0157:H7, Campylobacter and Salmonella. The Biosensor can detect 5-10 bacteria in a 1 mL sample without any pre-enrichment and to simultaneously screen up to 60 samples for different types of bacteria. The unique feature of this product is its ability to detect not only the presence, but also the viability of these pathogens. Dade Behring Inc. launched its Endogenous Thrombin Potential (ETP) assay for the measurement of thrombin activity for research studies. The ETP assay is based on the assumption that thrombin generation in plasma or whole blood reflects the sum of the activities and concentrations of procoagulant and anticoagulant substances. IRIS International, Inc. received FDA clearance to market its Body Fluids Module for analyzing cerebrospinal and serous body fluids utilizing the Company's iQ200 product platform. The Body Fluids Module enables the system to analyze cerebrospinal fluid (CSF) and serous fluids such as peritoneal (abdominal), pericardial (heart), and pleural (lung) in order to examine and count red blood cells and nucleated cells. Isotechnika Inc. is developing, Diatest for the diagnosis of diabetic indications and monitoring glycemic control. The Diatest, a 13C glucose breath test, provides a tool to investigate insulin resistance. The Diatest FDA trial is expected to commence by the third quarter of 2005. Mediscience Technology, Corp. is developing the Cancer Detection (CD) Map, to facilitate the acquisition of fluorescence images from surgical breast specimens following lumpectomies and surgical procedures. The instrument will be used to define the margins of tumors at the point-of-care, thus allowing the physician to obtain greater success in achieving clear margins in real time during cancer surgery without the use of extrinsic dyes, drugs or other invasive agents. The CD-Map is a UV/visible fluorescence imaging system designed to gain image emission from native fluorophors in tissue. Panbio Limited signed an agreement to acquire intellectual property from Corixa Corporation that would assist in the development of new assays for the diagnosis of the tick borne diseases, Ehrlichiosis and Babesiosis. Radiometer launched the TCM40, a monitor that can simultaneously measure patient ventilation and oxygenation status. It provides continuous and non- invasive monitoring of oxygen and carbon dioxide together with oxygen saturation levels.
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