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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 November 1999

Bayer Corporation will acquire the assets of OSI Pharmaceutical's diagnostics business, including the assets of OSI's wholly owned diagnostics subsidiary, Oncogene Science Diagnostics (OSDI). OSI will receive $10 million up-front from Bayer for the acquisition of OSDI, with an additional payment of $1 million to be made to OSI by 2001. OSI had been collaborating with Bayer since 1997 and together had developed the diagnostic test for the breast cancer marker HER-2/neu, which is currently marketed abroad.

Becton, Dickinson and Company has received FDA clearance to market its BDProbeTec ET System for the direct qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae, two of the most common causes of sexually transmitted diseases (STDs). The test has been cleared for use with endocervical swabs, male urethral swabs, and with female and male urine. The BDProbeTec ET System combines BD's proprietary Strand Displacement Amplification technology with an energy transfer (ET) detection method to provide one-hour assay time and multiple test runs per day.

Biosite Diagnostics Incorporated is collaborating with diaDexus, LLC, to identify and seek to validate potentially novel diagnostic markers in the cardiovascular field. The collaboration is part of Biosite's antibody development program known as Biosite Discovery. diaDexus has exclusive rights to develop diagnostic tests based on molecular targets and genetic alterations identified as part of SmithKline Beecham's drug discovery efforts and from SmithKline Beecham's collaboration with Human Genome Sciences. In addition, Incyte Pharmaceuticals has provided diaDexus with access to both its human and microbial databases (LifeSeq, Gold and PathoSeq) for diagnostic applications.

BioStar, Inc., a subsidiary of Thermo BioAnalysis has received FDA clearance to market its CdTOX A OIA kit, a rapid test to detect toxin A of Clostridium difficile bacteria, the most commonly identified cause of diarrhea and colitis in patients who have recently taken antibiotics.

ChromaVision Medical Systems Inc., manufacturer of the Automated Cellular Imaging System (ACIS), is collaborating with the University of California, Los Angeles, School of Medicine to enter into feasibility studies to validate a new ACIS-based test to detect and quantify the total HIV reservoir in the peripheral blood cells of HIV-infected persons. The ACIS viral load test, using currently available IHC staining methods, has the potential to allow the pathologist or laboratory technician to quantify accurately the number of virus infected cells.

Cranfield University is developing the Diag-Nose, an electronic device, to diagnose urinary tract infections. The instrument has been used for assessing the quality of food in the food industry. Urine is mixed with a special growth medium that contains certain compounds. When the bacteria causing the infection eat the compounds, they produce characteristic odors that are detected by the electronic nose, in 5 or 6 hours.

Dade Behring Inc. has received FDA clearance to market its new N High Sensitivity C-reactive protein (CRP) test that offers physicians the ability to assess risk of cardiovascular and peripheral vascular disease many years before its occurrence by detecting low levels of C-reactive protein in the blood. The N High Sensitivity CRP assay can detect levels of C-reactive protein as low as 0.175 mg/l, much lower than conventional C-reactive protein assays. Dade Behring has partnered with Quest Diagnostics Incorporated, to make this assay commercially available to physicians nationwide. C-reactive protein is an acute-phase protein, which rises due to infection, tissue injury, or inflammatory processes such as rheumatoid arthritis, cardiovascular disease and peripheral vascular disease.

Genzyme Genetics, a business unit of Genzyme General, has launched an improved test for detecting genetic mutations that cause cystic fibrosis. The updated test, CF86, screens for additional mutations not included in Genzyme's previous cystic fibrosis test, CF70. The new mutations include those specific to individuals with African American, southern European and northern European Caucasian backgrounds, and patients exhibiting mild cystic fibrosis symptoms.

Caduceon Inc., the biotechnology division of IDS Intelligent Detection Systems has developed an automated breath analysis technology based on IDS' core sensory technology that uses a normal breath sample.

MedMira Laboratories' Rapid Reader 2000 has been approved by Health Canada. The Rapid Reader 2000 uses image analysis technology to analyse the intensity of a coloured dot that is produced as a result of a positive MedMira Rapid Screen test for HIV. Rapid Reader 2000, which is expected to be introduced to international markets within the next six months at a cost of $40,000.

Quantech, Ltd. has received FDA clearance to market a quantitative CK-MB cardiac test. The other proteins are myoglobin, for which Quantech has already received FDA clearance for its myoglobin test, and troponin I, a test for which Quantech has completed development and will submit to the FDA. All three proteins will be combined by Quantech into a cardiac test panel that will be available on its Patient Treatment Information Platform for the hospital emergency department. Quantech's system uses its proprietary Surface Plasmon Resonance technology. Quantech's instrument is expected to include an initial menu of tests grouped in patient diagnosis-related panels including cardiac enzymes , pregnancy, red and white blood cell counts, blood coagulation and kidney function. Additional tests for liver functions, electrolytes, drugs of abuse, therapeutic drugs and other STAT tests are also expected to be available on the system.

Quantum Dot Corporation has obtained an exclusive license on luminescent nanoparticles from Indiana University, to develop, manufacture, market, and commercialize biological applications of Quantum Dot (Qdot) particles. Qdot particles, nanometer-sized semiconductor material that light up like molecular-sized LEDs, enable the detection and barcoding of biological materials from DNA to proteins. Applications of the technology include genetic analysis, flow cytometry, high-throughput screening, fluorescence microscopy, drug discovery, and diagnostics.

Quidel Corporation has announced its intention to buy the Dade Behring Rapignost Urine Test Strip business. The proposed cash purchase price is $5.75 million (including deferred payments) plus up to an additional $3 million on an earn-out basis. Included in the proposed transaction are continuing manufacturing obligations and certain distribution rights of Dade Behring.

Third Wave Technologies, Inc. has introduced a second set of Invader technology-based analyte specific reagents and assay controls for routine clinical use for the detection of a mutation in the Factor II (prothrombin) gene which is associated with deep vein thrombosis, pulmonary embolism and other potentially life threatening conditions. Third Wave already has

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* 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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