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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 2000

Axis-Shield has received FDA clearance to market its carbohydrate-deficient transferrin (CDT) test that detects people at risk of alcohol-related disease. The CDT test is already sold in Europe and will be marketed in the US by BioRad. Sustained heavy daily intake of alcohol results in elevated levels of CDT, which are maintained for several weeks even when people stop drinking.

Bayer Diagnostics has received FDA clearance to market the Bayer ELISA, HER-2/neu serum test for use in the follow-up and monitoring of patients with metastatic breast cancer. The test measures circulating levels of the HER-2/neu oncoprotein.

BioModa Inc. has filed patents for the use of Tetrakis Carboxy Phenyl Porphine (TCPP) for the screening of pre-cancerous conditions in human tissue. TCPP staining with automated microscopy and/or flow cytometry to accurately detect cancerous and pre-cancerous conditions very early. Biomoda expects to develop an economical mass screening test for cancer and pre-cancer. The first product to be introduced will be a lung cancer/dysplasia screening test.

BioPulse International, Inc. has acquired the exclusive rights in the U.S., Canada, Europe, Australia to Brigham Young University's TK1 (Thymidine Kinase 1), a marker which has shown high correlation to cancer activity and cancer stages. BioPulse is developing an ELISA kit format for early detection of cancer, monitoring the progress of cancer treatments, and developing a prognosis for patients who have completed treatment. The technology is currently protected by a key patent, which has approximately 15 years remaining.

Calypte Biomedical Corporation and Becton, Dickinson and Company have agreed to co-promote the Sentinel STD service for urine-based testing for HIV, chlamydia, and gonorrhea. Sentinel detects chlamydia and gonorrhea using the BDProbeTec ET CT/GC Amplified DNA assays and HIV-1 antibody using Calypte's HIV-1 antibody tests

Caprius, Inc.'s wholly owned subsidiary, Opus Diagnostics Inc. has entered into an agreement with Novartis Pharma AG for Opus to develop and market internationally an assay to monitor Certican (everolimus) blood levels. Certican is a Novartis drug candidate currently in development in late Phase III clinical studies for the treatment of renal transplant patients.

Diagnostic Products Corporation has launched outside the U.S. of a new diagnostic test for the quantitative measurement of L-homocysteine in plasma or serum. The new immunoassay joins a menu of cardiac markers available on DPC's IMMULITE and IMMULITE 2000 systems.

Genelex Corporation has begun offering drug response gene tests directly to the public. Genelex markets a screen for the CYP2D6 drug metabolizing enzyme. CYP26D acts on about a quarter of all prescription drugs, including Prozac, Paxil, Zoloft, Effexor, Hydrocodone, Risperdel, Toprol, Ultram, Ziac and the over-the-counter drugs, Allegria, Dytuss and Tusstat. The CYP26D screen determines whether the individual metabolizes these drugs at a slow, intermediate, fast, or super-fast rate.

Diabetic.com has entered a strategic partnership with Home Diagnostics, Inc., a manufacturer of diabetes testing products. Diabetic.com will distribute co-branded blood glucose monitoring test strips and meters to its consumers under the Diabetic.com and Prestige Smart System brand names.

Lifestream Technologies will introduce its new home cholesterol testing device through The Sharper Image catalog, stores, and web site beginning January 2001. The Lifestream Cholesterol Monitor incorporates the Microsoft Smart Card Operating System that can store up to 200 test results.

Paradigm Genetics Inc., and Prionics A.G. are developing blood-based diagnostics for the detection of Creutzfeld-Jakob Disease in humans and Bovine Spongiform Encephalopathy, mad cow disease, in cattle.

Quidel Corporation has launched its rapid QuickVue Influenza Test over-the-counter to consumers in three European countries. This test is now available in pharmacies in Italy, Germany and the United Kingdom.

TheraSense has received FDA clearance for the expanded use of FreeStyle, a blood glucose monitoring system that allows people with diabetes to obtain a blood sample from places other than fingertips. This new clearance permits the use of FreeStyle on the upper arm, thigh, calf, and anywhere on the hand, in addition to the previously cleared forearm testing site.

Trinity Biotech PLC has acquired Intracel Corp.'s Bartels Inc. unit for $9.3 million comprising $3.2 million in stock and $6.1 million in cash. The Bartels product range includes antigen detection kits for Herpes Simplex Virus, and respiratory viruses such as Influenza A and B, Parainfluenza Viruses 1,2 and 3, and Respiratory Syncitial Virus. Bartels also manufactures and sells infectious disease confirmatory reagents.

Ventana Medical Systems, Inc. has received FDA clearance to market its Pathway HER 2 (cloneCB11) for the detection of C-ERBB-2 antigen in routine pathological samples on Ventana automated immunohistochemistry slide-staining devices. It is indicated as an aid in the assessment of breast cancer patients who could benefit from Genentech's Herceptin therapy.

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* 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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