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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 December 2005

Biophage Pharma Inc. is developing BacTrapping system, a platform for the selective isolation and concentration of bacteria based on the unique properties of natural phages. The system can be used alone or in combination with the company's PDS Biosensor. The Biosensor can detect 5-10 bacteria in a 1 mL sample without any pre-enrichment and can simultaneously screen up to 60 samples for different types of bacteria.

Diazyme Laboratories received FDA clearance to market its Enzymatic Total Bile Acids Assay Kit for the quantitative determination of total bile acids in human blood samples. Total bile acids are elevated in patients with acute hepatitis, chronic hepatitis, liver sclerosis, and liver cancer and are a sensitive indicator for monitoring the effectiveness of interferon treatment of chronic hepatitis C patients.

E-Z-EM, Inc. and Nova Biomedical are developing the EZ CHEM blood analyzer. E-Z-EM has exclusive rights to market the product to radiologists and gastroenterologists in North America, with additional marketing rights worldwide. The system will be used to evaluate a patient's kidney function before receiving IV contrast prior to a CT exam.

Inverness Medical Innovations, Inc. received FDA clearance to market its Albumin Cobalt Binding test for detection of Ischemia Modified Albumin (IMA) on the Roche Diagnostics Corporation Cobas Integra 700 and Cobas Integra 800 chemistry analyzer systems. IMA is a key marker of cardiac ischemia.

IPGDx has developed PrognostiCheck, a noninvasive device to aid in end of life treatment decisions. The device captures and reports a basic level of cellular physiology, illustrating the plasma cell membrane. The test is repeated over time to track the dynamic changes in each patient in order to optimize treatment and also to recognize when treatment may no longer be effective.

MonoGen, Inc. received FDA clearance to market its MonoPrep Pap Test. The FDA specified that the MonoGen premarket approval application is approvable subject to a satisfactory outcome from the inspection of the company's manufacturing facilities and final agreement on labeling.

Nanogen, Inc. is buying Spectral Diagnostics' rapid cardiac immunoassay test business, including the cardiac STATus, Decision Point and i-Lynx product lines for CDN$9 million. Nanogen will assume related sales, marketing and manufacturing activities. The transaction is expected to close during the first quarter of 2006.

Oxford Immunotec's T SPOT-TB tuberculosis test has been approved for use in Europe. The test is expected to replace the century old tuberculin skin test, the oldest diagnostic test still in use today.

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* Product developments - November 2005
* Product developments - October 2005
* Product developments - September 2005
* Product developments - Summer 2005
* Product developments - May 2005
* Product developments - April 2005
* Product developments - March 2005
* Product developments - February 2005
* Product developments - January 2005
* Product developments - December 2004
* Product developments - November 2004
* Product developments - October 2004
* Product developments - September 2004
* Product developments - May 2004
* 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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