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The following is a review of diagnostic product developments worldwide

The 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.

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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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* Product developments - April 2004
* Product developments - March 2004
* Product developments - February 2004
* Product developments - January 2004
* Product developments - December 2003
* Product developments - November 2003
* Product developments - October 2003
* Product developments - September 2003
* Product developments - Summer 2003
* Product developments - May 2003
* Product developments - April 2003
* Product developments - March 2003
* Product developments - April 04003
* Product developments - January 2003
* Product developments - December 2002
* Product developments - November 2002
* Product developments - October 2002
* Product developments - September 2002
* Product developments - Summer 2002
* Product developments - June 2002
* Product developments - May 2002
* Product developments - April 2002
* Product developments - March 2002
* Product developments - April 04002
* Product developments - January 2002
* Product developments - December 2001
* Product developments - November 2001
* Product developments - October 2001
* Product developments - September 2001
* Product developments - Summer 2001
* Product developments - May 2001
* Product developments - April 2001
* Product developments - March 2001
* Product developments - April 04001
* Product developments - January 2001
* Product developments - December 2000
* Product developments - November 2000
* Product developments - October 2000
* Product developments - September 2000
* Product developments - July - August 2000
* Product developments - June 2000
* Product developments - May 2000
* Product developments - April 2000
* Product developments - March 2000
* Product developments - Febuary 2000
* Product developments - January 2000
* Product developments - December 1999
* Product developments - November 1999
* Product developments - October 1999
* Product developments - September 1999
* Product developments - August 1999
* Product developments - July 1999
* Product developments - June 1999
* Product developments - May 1999
* Product developments - April 1999
* Product developments - March 1999
* Product developments - Febuary 1999
* Product developments - January 1999
* Product developments - December 1998
* Product developments - November 1998
* Product developments - October 1998
* Product developments - September 1998
* Product developments - August 1998
* Product developments - July 1998
* Product developments - June 1998
* Product developments - May 1998
* Product developments - Avril 1998
* Product developments - March 1998
* Product developments - February 1998
* Product developments - January 1998
* Product developments - July 1997
* Product developments - June 1997
* Product developments - May 1997
* Product developments - April 1997
* Product developments - March 1997
* Product developments - February 1997
* Product developments - January 1997
* Product developments - December 1996
* Product developments - November 1996
* Product developments - October 1996
* Product developments - September 1996
* Product developments - August 1996
* Product developments - July 1996
* Product developments - June 1996

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Last modified: June 03, 2004