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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 February 1999

AccuMed International has sold its Microbiology Business to TREK Diagnostics Systems, a new entity formed by Key Equity Capital and Mr. Michael D. Burke, a former AccuMed executive. The purchase price for the Business was $15,250,000 in cash (subject to post-closing adjustment) and the assumption of certain liabilities. AccuMed will be focusing its efforts on its cytology-related products.

Becton Dickinson and Company has acquired Biometric Imaging, Inc., a privately-held company that manufactures IMAGN 2000, a cellular analysis instrument, based on a proprietary technology called microvolume fluorimetry. BMI has received FDA clearance to market the IMAGN 2000, and four clinical tests, STELLer, 4T8, and two CEQer Assays. These assays address three clinical areas respectively: cancer patient management for transplantation medicine, AIDS patient management for infectious diseases, and quality control monitoring of blood products for transfusion medicine.

Bio-Rad Laboratories has received a US patent for an imaging method and apparatus to detect fluorescence in situ hybridization (FISH). The instrument allows the user to simultaneously acquire images from several different colors. This system, used in conjunction with a combinatorial fluorescence approach, is able to create a FISH karyotype with each chromosome being painted with a different color.

Biosite Diagnostics Incorporated has settled its patent dispute with Spectral Diagnostics and has launched its Triage Cardiac System, a rapid diagnostic test for the quantitation of three cardiac markers -- CK-MB, troponin I and myoglobin.

Bion Diagnostic Sciences has been granted CLIA waived status for its BTA stat test. Physicians can now use the test to detect recurrent bladder cancer as an aid in the management of bladder cancer patients in conjunction with cystoscopy. The BTA stat test is a single step rapid immunoassay, which requires 5 drops of urine and provides results in 5 minutes.

Chembio Diagnostic Systems has received FDA clearance to market its PreVue test for Lyme disease that can be done in a doctor's office. The test provides results in an hour at the point of care.

Chiron Corp. has received FDA clearance to market its RIBA HCV 3.0 co-marketed with Ortho Diagnostics.

First Medical, Inc. has announced that it will resume operations, the company has been acquired and recapitalized by a group of former executives and an investor group led by members of the Zilkha family. First medical had received FDA clearance to market, the Alpha Dx, a system for the simultaneous quantitation of up to four cardiac markers: CK, CK-MB, myoglobin, and Troponin I.

Ostex International has received FDA clearance to market the new Osteomark NTx Serum test. This is the company's first new product since the introduction of the Osteomark NTx test in a urine format. NTx Serum provides a quantitative measure of cross-linked N-telopeptides of type I collagen (NTx) in serum as an indicator of human bone collagen breakdown (resorption).

Quest Diagnostics Incorporated has acquired the clinical laboratory operations of SmithKline Beecham plc for approximately $1.3 billion in cash and stock. Under the terms of the agreement Quest Diagnostics will acquire SmithKline Beecham Clinical Laboratories, including its clinical testing operations, clinical trials testing, corporate health services, and laboratory information products businesses. SBCL had 1998 revenues of $1.6 billion.

SenDx Medical, Inc. has been granted a US patent for a method and apparatus for measuring resistance of a blood sample in order to determine the hematocrit of that blood sample. The present invention makes a direct ratiometric measurement.

Spectral Diagnostics has signed an agreement with Sigma Diagnostics for the development and sale of cardiac markers in the laboratory-based instrument market. Later this year Spectral's cardiac markers will be available on laboratory-based instruments and will complement Spectral's point-of-care cardiac rapid format panel tests. Spectral has received FDA approval for the marketing of the myoglobin latex-based assay.

Welch Allyn, Inc. and SpectRx, Inc. have signed an agreement to jointly research, develop, and market non-invasive cervical and skin cancer diagnostic products. The companies will use SpectRx's proprietary biophotonic technology to identify cancers painlessly and non-invasively. Under terms of the agreement, the two companies will jointly share in development costs and sales of products developed. 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 - 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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Last modified: February 28, 1999