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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 April 1998

Abbott Laboratories and International Murex Technologies Corp. have entered into a definitive agreement for Abbott to acquire Murex in a cash tender offer valued at approximately $234 million or $13 per share. The Abbott and Murex boards of directors have unanimously approved the offer. The tender offer is expected to be completed in approximately five weeks, subject to regulatory approvals and customary closing conditions.

American Biogenetic Sciences, Copiague, NY, signed an agreement with Trevigen, Inc. to produce monoclonal antibodies ABS's patented Antigen Free technology in exchange for payments and royalties. ABS has agreed to produce four monoclonal antibodies for Trevigen. Trevigen, a private Maryland-based corporation, is developing screening assays for the detection of apoptosis which plays a role in certain neurodegenerative disorders (such as Alzheimer's disease and Parkinson's disease), and has agreed to evaluate ABS' neurological compounds in this screening assay.

Becton Dickinson Immunocytometry Systems has entered into an alliance with the Diagnostics Division of Abbott Laboratories to advance the development of new, fully automated immuno-hematology applications. The first product of this alliance is an immunological platelet analysis assay, utilizing Becton Dickinson's CD61 monoclonal antibody and proprietary reagent technology, and Abbott's CELL-DYN 4000 hematology system. Abbott and BDIS are also developing applications of CD4 and CD8 counts for the CELL-DYN 4000 hematology system.

Becton Dickinson and Company and Cygnus, Inc. have terminated their distribution agreement for the GlucoWatch, a painless, bloodless and automatic glucose monitoring system being developed by Cygnus for people with diabetes. The agreement covered worldwide distribution with the exception of Japan and Korea.

Biocircuits Corp., Sunnyvale, CA, has received clearance from the U.S. FDA to market its Free T4 assay. Discussions are ongoing with Biocircuits marketing partner, Becton Dickinson, regarding the exact format, such as in combination with TSH, in which the assay will be marketed."

Biomira Inc., Edmonton, AB has announced its intention to sell its TRUQUANT blood test kits for detecting breast, ovarian and gastrointestinal cancers to Centocor Diagnostics, Inc., Malvern, PA. The sale includes various antibodies and antigens for in vitro diagnostics purposes, plus the equipment used in product development. The diagnostic kits are currently manufactured at Biomira's wholly owned subsidiary in Toronto.

Biopool International Inc., Ventura, Ca has received US FDA approval to market a fetal screening test for the detection of D(Rh) positive red cells in D negative maternal samples. The Fetal D Tection Kit is composed of indicator cells, positive and negative control cells, a specially formulated chemically modified Anti-D reagent in a customized diluent and counting chamber slides.

Diametrics Medical, Inc., St Paul, Minn, has filed a 510(k) application with the US FDA for three new tests for the IRMA SL Blood Analysis System; blood urea nitrogen (BUN), chloride, and glucose. The IRMA SL Blood Analysis System is a hand-held blood analyzer that performs POC blood gases, electrolytes and hematocrit using a disposable cartridge.

Diagnostic Products Corp. Los Angeles, Ca, has received notice from the U.S. Patent Office that the agency intends to grant a patent related to DPC's ImmuGold system, a point-of-care diagnostic instrument that is designed to provide results in less than five minutes for blood chemistry tests. The ImmuGold system, which is planned for market introduction in late 1999, is capable of quickly measuring cardiac markers, cancer markers, antibodies, hormones, therapeutic drugs, drugs of abuse and other substances at small concentrations. Test speed and sensitivity is made possible by the new biosensor design disclosed in the patent.

SmithKline Beecham's Clinical Laboratories, Collegeville, Pa, has introduced TestSure, a test service which will detect the presence of nitrites in urine samples submitted for workplace drug testing. Nitrites are sometimes secretly added to urine samples as an adulterant in an attempt to thwart the drug testing process. The TestSure adulterant test can be conducted in concert with the drug screening process and there are no additional specimen requirements.

SpectRx, Inc., Norcross, Ga, has launched to international distributors its BiliCheck, Non-invasive Bilirubin Analyzer and BiliCal Individual Calibration Tips. The BiliCheck is the first commercially available hand- held, painless, non-invasive bilirubin analyzer designed to replace the heel stick blood test given to many infants. The initial shipments are to neonatal product distributors in Europe, Asia, Australia and New Zealand. SpectRx has signed distribution partners in 26 countries. SpectRx is developing a bloodless personal glucose monitor with Abbott Laboratories and a non-invasive diabetes screening product with Roche Diagnostics BMC.

Technical Chemicals & Products, Inc., Pompano Beach, Fla, has developed the non-invasive TD GlucoseTM Monitoring System. TCPI has completed approximately 30% of its registration clinical studies to obtain correlation data between interstitial fluid glucose and venous blood glucose -- the purpose of which is to attempt to develop algorithms, or complex mathematical formulas, which could allow the TD Glucose meter to display glucose levels equivalent to venous blood glucose. These clinical activities are expected to be substantially completed during the first half of 1998. Submission of clinical data to the FDA is anticipated to be made as soon as possible thereafter.

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* 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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