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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 1998

Bio-Rad Laboratories has signed a distribution agreement with Quantase Ltd giving Bio-Rad exclusive worldwide rights to distribute the Quantase line of diagnostic tests for newborn screening, Phenylketonuria, Galactosemia, Glucose -- 6-Phosphate Dehydrogenase (G-6-PD) Deficiency, and immunoreactive trypsinogen (IRT), a marker for Cystic Fibrosis. This agreement expands an already broad range of newborn screening products and services offered to the clinical laboratory by Bio-Rad.

Calypte Biomedical Corp. has entered into an agreement to acquire the Western blot product line for urine-based and serum-based HIV-1 Western blot products, as well as a confirmatory test for Lyme Disease and Human T-Lymphotropic Virus (HTLV). from Cambridge Biotech Corporation, a wholly-owned subsidiary of bioMerieux, Inc., for $500,000 in cash, 400,000 shares of Calypte common stock, warrants to acquire 600,000 shares of Calypte common stock at prices ranging from $8.00 to $12.00 per share, and a royalty based upon product sales. Calypte will assume full managerial control upon FDA's approval of the transfer of the product licenses to Calypte.

Centocor, Inc. has signed a definitive agreement to sell its oncology diagnostics business to Fujirebio, Inc., of Japan, for approximately $37.5 million. Fujirebio will purchase Centocor's in vitro diagnostic oncology business, which includes immunoassays using monoclonal antibody technology that aids in the detection and monitoring of solid tumor cancers. Revenues for Centocor's diagnostics business were $35.4 million in 1997.

ChemTrak has signed a letter of intent to sell all of its assets and operations, including its patents and licenses for all of its product lines with the exception of Parent's Alert Home Drug Test Service to Clinimetrics Research Associates Inc. of San Jose, Calif. Clinimetrics would assume certain liabilities and pay additional funds to the company. Proceeds of the sale are expected to satisfy the claims of secured creditors and a substantial amount of the unsecured creditors. Due diligence has begun and a definitive agreement is expected to be signed by Nov. 30, 1998.

Diagnology, Inc. has filed a 510 (k ) notification with the US FDA for clearance to market its POCkit HSV 2 Rapid Test. The POCkit Test would be the first point-of-care type-specific test to identify individuals infected with herpes simplex virus type 2 (HSV-2). This test can be performed with results available in less than 10 minutes. The test is an immuno-based assay and will be used in the physicians' office for whole blood (capillary) or with serum in the laboratory.

Digene Corporation has entered into a strategic development agreement with MedImmune, Inc. to develop DNA and mRNA expression tests for HPV based on Digene's Hybrid Capture II technology. If successful, the new tests could be used by MedImmune for preclinical and clinical evaluations as part of its collaboration with SmithKline Beecham for the development of HPV vaccines. In addition, Digene will provide HPV DNA analysis and cytology testing to MedImmune for evaluation of clinical specimens.

Fuji Chemical Industries, Ltd. has developed a new diagnostic kit to measure urinary type-IV collagen, which protein can be used clinically as a marker for diabetic nephropathy at its early stage. Type-IV collagen is one of the main proteins forming the basement membrane, and it is postulated that the abnormal presence of this type of collagen in the urine is due to its release from renal elements such as glomerular epithelial cells, rather than due to filtration from the peripheral blood.

IMI International Medical Innovations has completed clinical trials on its non-invasive cholesterol test Cholesterol 1,2,3, an IMI patented point-of-care technology, which measures cholesterol at the skin surface in three minutes in a manner that does not require blood, is painless and has no requirement for pre-test fasting.

Ortho Clinical Diagnostics has received FDA clearance to market its Summit System (OSS) and Ortho Summit Processor (OSP) developed in collaboration with Cotelligent. The system is designed to replace existing blood screening systems for hepatitis and retroviruses, including HIV and HTLV. The first systems are planned for installation by the end of 1998.

Qiagen N.V. has signed a five-year agreement with Abbott Laboratories to supply Abbott with various proprietary nucleic acid sample purification and preparation products, to be marketed by Abbott for use with Abbott's LCx probe-based diagnostic system. QIAGEN will retain the rights to market these technologies in all other formats.

Sanofi Diagnostics Pasteur has received FDA clearance to market its Genetic Systems HIV-1 Western Blot to verify the presence of antibody to HIV-1 viruses detected by other test procedures in human serum, plasma, or dried blood specimens. The test is being made available immediately to testing laboratories by Sanofi Diagnostics Pasteur. The test has ready-to-use reagents and can be run in less than 2-1/2 hours. It is the only supplemental, more-specific test approved for dried blood specimens.

Thermo BioAnalysis Corporation has completed the acquisition of privately held BioStar, Inc. The purchase price for the assets and the assumption of certain liabilities was $28,911,000 in cash. BioStar's revenues have grown by 25 percent or more over the last three years to approximately $20 million annualized for 1998. BioStar markets point-of-care rapid diagnostic test kits for strep A, group B strep, chlamydia, mononucleosis, and pregnancy.

Ventana Medical Systems, Inc. has acquired Oncor, Inc.'s in situ hybridization business for $5.5 million in cash. In 1999, Ventana plans to launch an in situ hybridization system that will automate Oncor's gene based tests.

Vysis, Inc. has developed an automated robotic specimen processor under a development contract with Mercer Scientific International Corp. and a supply agreement with Carl Zeiss, Inc. Mercer will re-engineer one of Zeiss' existing automated slide stainers to process clinical and research tests based on Vysis' patented FISH (Fluorescence In Situ Hybridization) technology. The system is slated for introduction during the first quarter of 1999.

Welch Allyn, Inc. and SpectRx, have signed a letter of intent to jointly research, develop, and market non-invasive cervical and skin cancer diagnostic products, based on SpectRx's proprietary biophotonic technology to identify cancers. Biophotonics is the technology of using light beams and other forms of energy to diagnose and monitor medical conditions.

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* 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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