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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 April 2000

Bayer Diagnostics and PharmaNetics, Inc. (Cardiovascular Diagnostics, Inc.) have received FDA clearance to market a new Low Range Heparin Management Test (LHMT) for the Bayer Rapidpoint Coag system.
The LHMT measures lower doses of heparin and will be used primarily in diagnostic and interventional cardiology procedures. The test completes Rapidpoint Coag's menu of six tests for total heparin management used in numerous therapies, and various dosages, throughout the hospital. Bayer expects to launch the heparin management system as Rapidpoint Accent
summer 2000.

Beckman Coulter has received FDA clearance to market its Access Ostase blood test as an aid in the management of osteoporosis and Paget's disease. The assay is available on Beckman Coulter's Access Immunoassay System. The ostase assay assesses bone metabolism by measuring the level o bone-specific alkaline phosphatase.

Bio-Rad Laboratories, Inc. and Japan's Nikon Corporation are collaborating to manufacture and market RTS 2000, a microscope with capabilities for video rate confocal imaging. The system will be manufactured by Nikon in Japan and marketed and supported worldwide by Bio-Rad. A key feature of the unit is its capability for multi-photon excitation, a technology licensed exclusively to Bio-Rad by Cornell Research Foundation, thereby permitting observation of live cells undergoing changes for extended periods of time. By combining this feature with Nikon's video-rate scanning technology, the RTS 2000 system provides scientists with the ability to study living organisms in real time.

Biomerica, Inc. has introduced the GliaQuant-IgG test to detect and monitor the presence of gliadin, a protein that causes Celiac disease in many individuals.

Biosafe Medical Technologies, Inc., has launched a home screening test for prostate disease that can be done at home. The PSA4 is a self-collected, laboratory analyzed, blood test that measures PSA. Using the included finger lancet, a few drops of blood are taken from the finger, placed on a small collection card and sent to Biosafe Laboratories for analysis. The cost is $39.95.

ChoicePoint Health Systems Inc. has launched Appraise, a diabetes monitoring system that enables people with diabetes to quickly and conveniently collect their own specimens for Hemoglobin A1c and Microalbumin at home. The system allows MCOs to enroll their patients into the system by establishing tests to be performed, testing parameters and frequency of testing. Specimen collection kits are automatically sent to the patient's home. Once the specimen is collected, the kit is sent directly to the ChoicePoint Health Systems' laboratory. Test results are sent to the physician prior to the patient's scheduled appointment.

Dade Behring Inc has received FDA clearance to market the Advanced D-Dimer assay, an automated and quantitative assay used to detect cross-linked fibrin degradation products (XL-FDPs) containing D-dimer and indicating the breakdown of insoluble fibrin clots. The Allegiance Healthcare System is the distributor of the Advanced D-Dimer assay. The assay, a latex-enhanced turbidimetric test, is performed on the automated BCS analyzer.

Diagnostic Products Corporation (DPC) has introduced in Europe an automated test for early diagnosis and prognosis of systemic gram-negative infections. The test was developed with XOMA's patented technology that uses LBP (lipopolysaccharide binding protein) as a biochemical marker of systemic exposure to gram-negative bacteria and endotoxin. The test is designed for use on DPC's IMMULITE benchtop analyzer

Roche Diagnostics has signed an agreement to acquire AVL's medical instruments division. Financial terms were unavailable. AVL is a global supplier of blood gas and electrolyte analyzers. AVL has also been a leading supplier of sensor technology to the diagnostics industry.

Roche Molecular Systems, Inc. announced that the FDA has accepted its pre-market approval filing and has granted Roche expedited review for two tests designed to directly detect the presence of HCV. The tests, AMPLICOR HCV Test, version 2.0, and the COBAS AMPLICOR HCV Test, version 2.0, are qualitative RNA tests.

Sandia National Laboratories is developing the smart scalpel, a computerized fiber-optic laser device, able to analyze cells and determine instantly if they're cancerous. The device contains a microscopic spectrometer that analyzes protein density in a cell and a tiny vacuum that sucks cells through microchip-connected sensors for analysis during surgery. Fiber-optics feed the information into a computer to provide instant feedback to the surgeon.

Visible Genetics Inc. and PE Biosystems have entered into a worldwide agreement whereby Visible gains access to certain PE patents and intellectual property. The agreement enables Visible to utilize certain PE Biosystems technology to manufacture and sell DNA sequencing instruments, as well as manufacture and sell clinical sequencing kits to run on DNA sequencing instruments manufactured by Visible, PE Biosystems and other companies. The intellectual property includes two patents licensed to PE Biosystems from the California Institute of Technology which are the subject of a patent infringement suit filed by PE Biosystems against Visible and which has been withdrawn.

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* 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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