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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 May 2004
Dear Reader, it is time for our annual summer hiatus - time for BBQ, sun and beach. Have a great summer. We will be back in September. Abbott Labs has submitted its Freestyle Navigator to the FDA for market approval. The device is a non-invasive glucose monitoring test that transmits blood-sugar readings from the fluid under the skin to a pager-sized receiver. It gives readings every minute. Abbott is hoping it can get on the market in 12 to 18 months. Accelr8 Technology Corp. is developing its BACcelr8r rapid microbial diagnostic platform. The BACcelr8r design consists of an automated instrument and disposable analyzer cartridges that automatically processes the sample and delivers results electronically. All operations take place within a closed, disposable cartridge that uses Accelr8's proprietary technology. Advanced Analytical has developed the RBD 3000, a fully automated system for microbial testing, providing accurate bacteria, yeast mold and parasite measurements in minutes. The system is based on the principles of flow cytometry and robotics for sample processing. It allows up to 42 samples to be placed on the system for unattended analysis. Amersham and Bayer Diagnostics have entered into an exclusive worldwide agreement for joint development of assays and instrumentation for HIV sequencing as well as sequencing of other important infectious disease-causing pathogens. Amersham will supply a modified version of its existing MegaBACE gene sequencer instruments and Bayer will develop sequencing assay applications for this MegaBACE sequencer. Associates of Cape Cod, Inc. has received FDA clearance to market Glucatell, a serological assay for the qualitative detection of beta-glucan as an aid in the diagnosis of deep seated mycoses and fungemias. Glucatell measures (1,3)-beta-D-glucan, a fungal wall compound that is shed into the blood during fungal infections. Calypte Biomedical Corporation is developing a rapid test for HIV-1/2 that can be performed on an oral fluid sample. HIV results are available within 20 minutes. Genzyme Corporation has received FDA clearance to market the OSOM Trichomonas Rapid Test to detect trichomonas infection - a frequent cause of vaginitis/vaginosis, and the most common, non-viral sexually transmitted disease in the world. The test is an immunochromatographic assay that detects pathogen antigens directly from vaginal swabs. IMI International Medical Innovations Inc. has entered into an exclusive worldwide non- Canadian licensing agreement with McNeil Consumer Healthcare for its non-invasive cardiovascular risk assessment technology under the brand name PREVU Coronary Heart Disease Predictor. Meridian Bioscience, Inc. introduced its ImmunoCard Toxins A&B in the European market. The test detects toxins produced by strains of the Clostridium difficile bacterium (C. difficile). ImmunoCard Toxins A&B is a simple, rapid test that provides visual color-change results in minutes.
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