The following is a review of diagnostic product developments worldwide

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.

i-STAT Corporation and Abbott Laboratories have entered into a sales, marketing and research alliance whereby Abbott will assume sales and marketing responsibility for the i-STAT products in the human health market, while collaborating in the development of new products leveraging both i-STAT's and Abbott's technology. The parties expect that Abbott will commence sales and marketing of the i-STAT products in the United States on January 1, 1999. A subsequent international roll out is planned.

Chiron Corp has agreed to sell its in vitro diagnostics subsidiary, Chiron Diagnostics Corporation, to Bayer Corp. This will include a previous agreement signed by Cardiovascular Diagnostics and Chiron Diagnostics giving global distribution rights for certain Cardiovascular Diagnostics coagulation tests.

Roche Diagnostics and Eli Lilly and Company have collaborated on easy-to-use talking blood glucose monitoring system for people who are visually impaired The Accu-Chek Voicemate talks patients who are blind or visually impaired through blood glucose monitoring and reads bar-coded labels of insulin vials aloud to help them manage their diabetes.

The Imperial College of Science, Technology and Medicine in London has formed a joint venture company with Kiotech International Plc, a British biotechnology company, to develop and manufacture a breathalyser device that diagnoses ailments simply by sniffing a patient's breath. The new company, BodiTech, expects to produce its first prototype by 2002, when it will begin clinical trials.

Corgenix Medical Corporation has announced its intention to buy Integrated Diagnostics Inc., founded in 1984, a company that specializes in tests for the diagnosis of many infectious diseases, and standards used in flow cytometry, including Lyme disease, various forms of typhus, spotted fever such as Rocky Mountain Spotted Fever, Ehrlichia and dengue fever.

EntreMed Inc. and CytImmune Sciences Inc. have announced the product launch of the Endostatin Protein ACCUCYTE Immunoassay Kit, the first commercially available test for the detection of human Endostatin protein, a naturally occurring fragment of collagen XVIII. Antiangiogenic agents such as Endostatin starve tumors to death by blocking the growth of blood vessels that supply nutrients necessary for their proliferation.

Fisher HealthCare has signed an agreement to provide the healthcare market with Immunoassay and Hemoglobin A1c products from Tosoh Medics, Inc. including instruments reagents, and consumables.

Medical Analysis Systems Inc. (MAS) has acquired the TQC control product lines of Dade Behring. Medical Diagnostic Systems Inc. (MDS), a wholly-owned subsidiary of MAS, will retain 31 employees from Dade's Miami facilities and will continue to produce the full range of Dade products and operate the QC data system. MAS will maintain existing distribution channels for both MAS-brand products and the Dade TQC product line.

Meridian Diagnostics and Gull Laboratories have merged. The shareholders of Gull Laboratories will receive $2.25 in cash for each common share. Fresenius AG, the majority shareholder of Gull Laboratories, has agreed to vote its Gull shares in favor of the merger.

Saliva Diagnostic Systems has received FDA clearance to market the Stat-Simple pylori whole blood test for H. pylori.

Trinity Biotech has entered into an agreement with Strategic Diagnostics, Inc. to acquire an assay that measures Lipoprotein Lp(a), a predictor of premature atherosclerosis and coronary heart disease. The Macra Lp(a), is the only Lp(a) method cleared by the FDA for both diagnosis and risk assessment of coronary heart disease. Trinity intends to sell Macra Lp(a) in N. America through its marketing partner, Wampole Laboratories, a division of Carter Wallace.

DAKO Corp. has received FDA clearance to market the HercepTest and immunohistochemical test for HER2 overexpression. HercepTest is a result of an agreement announced in March 1998 between Genentech and DAKO.

Immucor has tendered a cash offer for all outstanding shares of the common stock of Gamma Biologicals. The offer is being made pursuant to the previously announced merger agreement among Immucor and Gamma Biologicals.

Pathobiotek Diagnostics is developing a molecular diagnostic kit for multiple sclerosis (MS) is approximately six months ahead of schedule. Pathobiotek researchers have isolated a bacterium that appears to be a causal cofactor of MS. Laboratory tests have shown that this bacterium correlates with symptoms of the disease.

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