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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 November 2003

Agenix subsidiary, AGEN BioMedical, and Biosite Inc. have signed a license and supply agreement for D-dimer. Biosite intends to incorporate AGEN's 3B6 antibody, specific for D-dimer, into its Triage Profiler S.O.B. Panel to identify the cause of shortness of breath, a symptom common to congestive heart failure, heart attack and pulmonary embolism. The S.O.B. Panel measures, BNP, D-dimer, myoglobin, CK-MB, and troponin I.

artus GmbH and Abbott Laboratories have introduced three real time PCR tests designed to run on the Applied Biosystems ABI PRISM 7000 Sequence Detection System - the RealArt HPA Coronavirus PCR Kit, RealArt C. trachomatis PCR Kit, and the RealArt M. tuberculosis PCR Reagents. All three tests are available worldwide, except in the US, Canada and Japan.

Ciphergen Biosystems, Inc. is developing a biomarker pattern for the diagnosis of Alzheimer's Disease. The array analyzes CSF proteins using Ciphergen's SELDI ProteinChip Biomarker System and Expression Difference Mapping methodology.

DiagnoCure has assigned to Gen-Probe the exclusive license for its urine gene PCA3(DD3) test for prostate cancer. The gene has been shown to be over-expressed only in malignant prostate tissue. Gen-Probe will pay DiagnoCure an upfront US $3 million fee, and future fees and contract development payments of up to US $7.5 million over the next three years and will pay DiagnoCure royalties of 8% on cumulative net product sales of up to $50 million, and royalties of 16% on cumulative net sales above $50 million.

Focus Technologies has received FDA clearance to market its IgM and IgG ELISA antibody detection diagnostic kits based on a West Nile Virus recombinant protein antigen licensed by the Centers for Disease Control and Prevention.

International Remote Imaging Systems, Inc. has entered into a distribution relationship with ARKRAY, Inc., for the AUTION JET AJ-4270, urine chemistry analyzer and related products designed for decentralized locations around the hospital, including emergency rooms and satellite labs.

Leica Microsystems Inc. has entered into an alliance with Sigma-Aldrich Corporation to distribute histology and cytology stains and reagents in the US for the medical, pharmaceutical, biotechnology and academic sectors.

NetImpact Holdings, Inc. has introduced its MDS 200, a POC instrument that utilizes samples of blood, saliva, sweat or urine to identify numerous diseases. The first shipments are targeted for Mali, Singapore, Vietnam, China and Mexico.

Oxoid Limited has launched a rapid test for the direct detection of antibodies to E. coli O157 Lipopolysaccharide in serum. The Oxoid O157 Check LPS Antibody Kit (DR0190M) is a latex agglutination test with results in 3 minutes.

QT 5, Inc. has acquired the exclusive worldwide rights to a blood and urine POC test platform designed for the Homeland Defense market. The platform incorporates a solid phase membrane and immunologically based reagents in a single-use disposable test device. The current product line includes a blood tests that have already received FDA approval including rubella, herpes virus, rotavirus, strep group A, infectious mononucleosis and early pregnancy. A 10-minute HIV1 and HIV2 test, cardiac markers and drug tests are in the pipeline.

Tomen America Inc. and Nippon Kayaku Co. Ltd. have received FDA clearance to market the GlycoMark test that measures the level of 1,5-anhydroglucitol (1,5-AG) for the intermediate term monitoring of glycemic control in people with diabetes. The marker reflects average glucose levels over a period of a few days to 2 weeks.

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* 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 - February 2003
* 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 - February 2002
* 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 - February 2001
* 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: December 2, 2003