The following is a review of diagnostic product developments worldwideThe 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.
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.
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.
- March 2000
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Last modified: April 30, 2000