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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 May 1997

International Murex Technologies, Toronto and Innogenetics NV, Belgium have launched their LiPA HIV-1 Reverse Transcriptase test a rapid assay that simultaneously identifies HIV resistance associated with the drugs AZT, ddl, ddC and 3TC.

Scios, Mountain View, Ca has signed an agreement with Abbott Laboratories granting Abbott a semi-exclusive license to the technology and patents developed by Scios relating to the cardiac hormone BNP (b-type natriuretic peptide). Elevated levels of BNP have been identified in the blood of patients with ventricular dysfunction ranging from asymptomatic individuals to symptomatic patients with heart failure.

Shimadzu Corp., Tokyo, has released a spectrophotometer for the ultraviolet and visible light regions which utilizes a photodiode array in the detector. With this array, numerous wavelengths of light can be measured at the same time and the components of a sample can be analyzed in around 1 second, compared to the usual several dozen seconds. The company has priced the Multi Spec-1500 at $160,000 and anticipates sales of 300 units per year to biotech companies and pharmaceutical firms.

TRI-MED Specialties, Lenexa, Kan has received US FDA approval to market its has approved the PYtest, the 14C urea breath test for the detection of Helicobacter pylori.

AccuMed International, Chicago, Ill, has received FDA clearance to market an expanded Sensititre HP MIC panel for susceptibility testing of resistant Streptococcus pneumonia and Hemophilus influenza pathogens.

Baxter Healthcare, Deerfield, Ill, has filed for market approval for its artificial blood product, HemAssist (Diaspirin Cross- linked Hemoglobin or DCLHb) in all 15 European Union countries. Baxter is the first company to have filed for regulatory approval for a hemoglobin-based, blood-substitutes technology.

Nanogen, San Diego, Ca and Becton, Dickinson and Co. have entered into a collaborative agreement to develop test systems to diagnose infectious disease. The diagnostic test will be based on Nanogen's proprietary DNA micro-chip and instrumentation technology and Becton Dickinson's proprietary system for DNA amplification.

BioSource International, Camarillo, Ca aims to start selling a PCR-based diagnostic for cytomegalovirus in early June. The CMV diagnostic tool will be the first commercial launch for the company.

Boehringer Mannheim Corporation has received US FDA approval to market its CoaguChek System for Prothrombin Time Self-Testing, a device that allows people taking anticoagulants to monitor themselves at home. To support the CoaguChek System, BMC also provides patients and physicians with a comprehensive quality management system for optimum management of their health, including in-depth standardized training, and technical support.

ChemTrak, Sunnyvale, Ca, has signed an exclusive agreement with Parent's Alert to market Parent's Alert Home Drug Test Service

The British Wellcome Trust has awarded $2.7 million to Cambridge University to develop an inexpensive dipstick DNA test that can detect hidden carriers of chlamydia.

Diagnostic Products Corp. and Metra Biosystems have begun international marketing of the IMMULITE Pyrilinks-D test for bone resorption. Metra's Pyrilinks-D technology will be available on DPC's automated IMMULITE immunoanalyser.

Hewlett-Packard Company has expanded the capabilities for the HP OmniCare CMS patient monitor, by including the i-STAT test cartridges on the system. It now offers stat blood tests at the patient's side. The HP Blood Analysis Module gives caregivers two-minute access to lab-quality test results for such things as blood gases, electrolytes and chemistries.

Immucor, Atlanta, Ga has introduction the IMAGN 2000, an automated cellular assay system for the enumeration of CD4+ and CD8+ T-cell lymphocytes, leukocytes and CD34+ stem cells. The instrument uses a proprietary technology called microvolume fluorometry.

Mosaic Technologies, Boston, Mass. has formed a collaboration with the American Red Cross to develop a rapid molecular probe assay for detecting small amounts of bacterial contamination in blood platelets. The test will use Mosaic's proprietary Bridge amplification process, oligonucleotide attachment chemistry, and a fiber optic-based detection system.

Northfield Laboratories, Baltimore, Md has begun phase III clinical trials of its blood substitute product, PolyHeme. Market introduction planned for sometime during 1999.

PerImmune, Rockville, Md has received US FDA clearance to market its AuraTek FDP, a physician's office-based test for use in detection of recurrence of bladder cancer.

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* 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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