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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 Summer 2005

Dear Reader, The summer flew by and what a summer it has been !!! As promised here are this summer's news highlights. Our monthly revisions begin in September. Happy Reading and Best Regards, Shara Rosen

Adlyfe, Inc. is developing a blood test for protein folding diseases such as Mad Cow disease, Sheep Scrapie and Creutzfeldt-Jacob disease in humans. The test is based on using small, synthetic peptides that mimic protein folding. The synthetic peptides detect the build up of damaging proteins in blood before they accumulate in the brain.

American Diagnostica, Inc. acquired a license to PAI cancer marker assays, held by Bayer Diagnostics. Bayer has an exclusive worldwide license from the Danish research foundation Cancerforskningsfonden af 1989 to market and sell PAI-1 antibodies for diagnostic use under U.S. Patent Nos. 5,422,245 and 6,271,352, as well as European Patent No. 229,126. These patents relate to monoclonal antibodies and their use in certain assays for an endothelial-type plasminogen activator inhibitor known as ePAI or PAI-1. ADI has taken a non-exclusive worldwide license under the patents to manufacture, use, sell, and offer to sell PAI-1 monoclonal antibodies and PAI-1 ELISA's for research purposes as well as for diagnostic or prognostic uses in non-tumor tissue extract assays.

Bayer Diagnostics and Olympus Life and Material Science Europa GmbH signed a non-exclusive supply and distribution agreement for an automated assay for B-type Natriuretic Peptide (BNP). Olympus will optimize Bayer Diagnostics' BNP assay for use on the Olympus AU3000i, scheduled for release in 2005 in Europe and 2006 in the U.S.

Beckman Coulter, Inc. signed a licensing agreement with Nephromics, LLC that provides Beckman Coulter access to all Nephromics' patents, patent applications and biologics related to the detection, monitoring and risk assessment of preclampsia, the second leading cause of maternal deaths in the developed world.

BioArray Solutions, Ltd. received FDA clearance to market its ENA IgG BeadChip Test System, an immunoassay for the simultaneous detection of six antibodies to different extractable nuclear antigens (ENA). The test is used on the company's Array Imaging System (AIS 400).

Biosite Incorporated is developing a second generation Triage Cardio ProfilER Panel that will include myeloperoxidase (MPO), a marker of inflammation in the walls of coronary arteries. The panel now includes: troponin I, CK-MB, BNP and myoglobin in blood. Clinical trials are to begin by the end of 2005.

Biosite Incorporated acquired an exclusive license from Johannes Gutenberg University, Mainz, Germany for Caspase-1, a potentially important cardiovascular disease biomarker.

Cholestech Corporation was granted U.S. patent (6,881,581) and the European patent (EP 1,329,724) for a new method of measuring High Density Lipoprotein (HDL) in blood that permits the development of the Cholestech LDX Lipid Profile/Alanine Aminotransferase (Lipid/ALT) cassette by preventing the interference of the HDL chemistry with the ALT assay on the same cassette.

CombiMatrix Group entered into a co-development agreement with STMicroelectronics that combines CombiMatrix's proprietary ElectroChemical Detection Technology (ECD) with ST's In-Check Lab-on-Chip platform to investigate the feasibility of addressing the research and point-of-care diagnostics markets.

Compugen Ltd. and Biosite Incorporated entered into a collaboration for the development and commercialization of biomarkers discovered by Compugen. Compugen is expected to provide Biosite with comprehensive data on several gene targets to be nominated by Biosite.

Clarient Inc. and DakoCytomation signed a distribution agreement under which DakoCytomation will distribute the ChromaVision Automated Cellular Imaging System (ACIS) as an adjunct to the DakoCytomation suite of automated diagnostics equipment. DakoCytomation will ultimately integrate its automated staining platforms and optimized high quality reagents with Clarient's digital imaging system.

Diagnostic Products Corporation and Thermo Electron Corporation entered into an agreement for the co-development of a high throughput clinical chemistry platform. This platform will integrate with DPC's future immunochemistry platforms, and will be ideally suited for the medium and large volume laboratories both in the hospital and private laboratory segments.

Genzyme Corporation launched a flow cytometry test designed to detect the presence of residual disease in the blood and bone marrow of patients with B-cell chronic lymphocytic leukemia (B-CLL). This is the first cancer test Genzyme has launched to complement the B-CLL treatment Campath (alemtuzumab).

GW Medical Technologies is developing the LymPro Test to differentiate probable Alzheimer's disease from other dementias. The test is based on the evaluation of 11 immune system antigens by flow cytometry, coupled with an algorithm designed to define the molecular relationship of these antigens and Alzheimer's disease.

Hanson Technologies, Inc. is developing an integrated biological and chemical sensor to screen for BSE and other infectious diseases.

Home Diagnostics, Inc. launched Sidekick, an all-in-one blood glucose testing system that combines a vial of 50 test strips with a blood glucose monitor built right on top. The systems can be used in forearm or fingertip mode.

DM Group, Inc. entered into agreement with Sun Biomedical Laboratories, Inc. to acquire control of Sun's oral fluid testing technologies for drugs of abuse, tests for clinical applications and also process and device technologies.

Medtronic, Inc. received FDA clearance to market the Guardian RT. Continuous Glucose Monitoring System. The system displays real-time glucose values every five minutes and alerts patients when glucose levels become too high or too low. The system is calibrated twice a day (every 12 hours) by entering a glucose measurement from a standard blood glucose meter into the Guardian RT's monitor.

Inverness Medical subsidiary Wampole Laboratories signed an agreement with Roche Diagnostics to collaborate on the first automated diagnostic test for Ischemia Modified Albumin (IMA) to be used on the Roche Cobas Integra 700 and Cobas Integra 800 chemistry analyzer systems. Wampole will sell and distribute the IMA test for Roche's analyzers. The IMA assay is also available on the Roche/Hitachi Modular Analytic Plus, the Roche/Hitachi 911, and the Roche Cobas MIRA Plus analyzers.

SIRS-Lab GmbH entered into a collaboration agreement with Biosite Incorporated for the evaluation and potential commercialization of sepsis markers.

Sysmex America, Inc., signed a co-marketing agreement with Bio-Rad Laboratories, Inc., to co-market their complementary products, the Sysmex HST-NTM Hematology Automation Line and the Bio-Rad VARIANT II TURBO HST Hemoglobin Testing System, together. This agreement will provide laboratories with the ability to use one lavender top tube for testing CBCs, sed rates and HgbA1C.

Trinity Biotech plc acquired Primus Corporation, a marketer of instruments and reagents for hemoglobin A1c and hemoglobin variants for $12 million, consisting of a cash consideration of $9 million and a one-year promissory note of $3 million.

Whatman/Schleicher & Schuell formed a partnership with Privates Institut fur Immunologie und Molekulargenetik GmbH, a German laboratory that specializes in autoimmune and other clinical diagnostic assays, to develop, manufacture and distribute a protein biochip for autoimmune disease diagnosis using Whatman/Schleicher & Schuell's nitrocellulose-coated FAST slides for protein microarray assays.

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Last modified: September 5, 2005