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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 August 1999

Pathobiotek Diagnostics has introduced the EJ sensitivity system (EJSS), that is used to determine sensitivity of certain agents to a microorganism characterized by Pathobiotek that has been associated with MS and other immune diseases. The new sensitivity system joins Pathobiotek's product line introduced to select collaborators earlier this year. These products include EJ solid media, Lindner Modified/Culture Media, fluorescent in situ hybridization (FISH) kits and PCR kits.

Quidel has received FDA clearance to market a second generation point-of-care rapid diagnostic test for the detection of
H. pylori. The redesigned diagnostic test provides quicker results and is performed on a smaller blood sample compared with QUIDEL's existing H. pylori test.

Zymark Corporation has acquired SCITEC Automation Holdings SA, a Swiss-based laboratory automation company. Under the terms of the agreement, the Scitec organization will be integrated into Zymark's corporate structure. Details of the financial arrangements were not disclosed. Scitec is a custom systems integrator and a manufacturer of specialty peripherals and accessories, primarily for the Biotech and Pharmaceutical industries.

Immunicon Corporation has signed an exclusive licensing agreement with The University of Texas Southwestern Medical Center, Dallas to develop cell-based diagnostics for cancer detection, monitoring and staging. The principal investigator will be Jonathan W. Uhr, M.D., Professor of Microbiology and Internal Medicine.

Wireless MD, Inc. now markets a two-way wireless communications solution for the mobile physician. Through a strategic alliance with Med-I-Pro Systems, LLC; Wireless MD has created a two-way, real-time, interactive, medical data retrieval system that allows physicians to communicate directly with hospital databases, pharmaceutical manufacturers, managed care organizations, pharmacy retailers and the Internet.

Dade Behring has become OEM distributor of Labsystems' Clinical Laboratory Division (CLD) of Finland, Pre-Analytical System that automates clinical laboratory sample handling and preparation prior to analysis. The agreement applies worldwide (except Scandinavia) and is effective immediately. Labsystems' CLD will continue to sell the modular automation products independently.

LXN Corp. has received FDA clearance to market its new In Charge Diabetes Control System. Modeled after LXN's physician office product, the Duet Diabetes Control System, the In Charge System is designed for personal use. The In Charge System includes a small, hand-held monitor, which performs both a rapid blood glucose test and a test for glycated protein.

Cholestech Corporation and Fisher HealthCare have signed a non-exclusive, multi-year agreement for Fisher HealthCare to market the Cholestech L.D.X System in the US, to more than 75,000 acute care facilities and physician office laboratories in the United States. The Cholestech L.D.X is a POC device that can conduct multiple simultaneous diagnostic tests from a single drop of blood and provide results, in less than five minutes. In-Line Diagnostics' Transcutaneous Crit-Scan Gains FDA 51OK Approval

In addition, the L.D.X System has been selected by Parke-Davis, a division of Warner-Lambert Company as part of a nationwide cholesterol education and disease management initiative. Parke-Davis has provided an educational grant to support cholesterol screening and education in participating pharmacies, including: lipid management education, patient education concerning the risks of hyperlipidemia, and pharmacist support programs to test and counsel patients. The program, which will be launched in September of 1999, and run through August of 2000, is being made available to 90 retail pharmacies selected from McKessonHBOC, Inc.'s independent network of Valu-Rite/CareMax and Health Mart Preferred Pharmacies.

In-Line Diagnostics, Inc. has received FDA 51Ok approval to market the Crit-Scan, a transcutaneous hematocrit monitoring device. Crit-Scan's primary use will be in physician offices and blood banks. The Crit-Scan virtually eliminates the need for finger sticks associated with blood tests and blood donation. In-Line Diagnostics also markets the Crit-Line monitor used in acute and chronic hemodialysis.

LifePoint, Inc. is developing a chemistry reagent for the detection and measurement of alcohol in saliva specimens that will be used in a reagent cartridge that will combine immunochemistry methods for drugs of abuse and an enzymatic method for the detection of alcohol. Cholestech L.D.X System Chosen for Parke-Davis` 1999 Disease Management Initiative

Magnetic Diagnostics Inc. is developing a non-invasive home glucose (and multi-analyte) monitor, the Home Diagnostic Center using magnetic resonance spectroscopy. Once the HDC is developed and on the market, the patient will be able to test for glucose, without drawing a single drop of blood. Just inserting a single finger into the desktop unit will be all that is necessary to measure glucose and other key analytes that clinicians require for the successful management of diabetes. The HDC will be able to test for ketones, pH, lactate, creatinine, potassium, sodium, hydration state, ethanol, advanced glycation end-products, cholesterol, HDL and LDL.

Atairgin Technologies, Inc. is involved in an ovarian cancer research collaboration with Northwestern University in Evanston, Illinois, to develop and commercialize Atairgin's LPA test to detect ovarian cancer. The test is based on Atairgin's platform technology in lysophospholipids to develop an early detection marker for ovarian cancer.

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*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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