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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.

Welcome back to the StratCom monthly update, hope you had a healthy and productive summer. The following are highlights of diagnostics related events that took place in July and August 2000.

This site is updated monthly, feel free to visit and contact us.

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Product developments in July and August 2000

American Bio Medica Corp. has begun marketing its Drug Detector kit on its Web site, WWW.DRUG-DETECTOR.COM. The Drug Detector tests for the presence or absence of residue on surfaces from marijuana or cocaine without the need for urine, hair or saliva samples. The kit costs $34.95 per kit, with each kit containing enough collection papers to perform 10 tests.

The directors of Applied Biometrics Inc., have decided to terminate all its business operations and to dispose of its remaining corporate assets.

Barringer Technologies Inc. a manufacturer of trace drug and explosive detection equipment is developing a Pathogen and Biological Warfare detection device that combines signal amplification process coupled with ion mobility spectrometry detection. The company anticipates that this technology will reduce or total eliminate incubation times in microbiological organism detection and identification.

Boston Biomedica Inc.'s BBI Clinical Laboratories launched a new antibody test for Lyme Disease, the C6 Lyme Peptide ELISA. The company believes the new Lyme Disease test to provide results more accurate than other tests available.

Careside, Inc. has received FDA market clearance of its Careside Hemoglobin and Hematocrit blood tests. Clearance of hemoglobin and hematocrit brings the current number of cleared or exempt tests on the CARESIDE Analyzer to 40.

FlexSite Diagnostics, Inc. has received FDA clearance to market its UriSite Urine Collection Kit for Microalbumin/ Creatinine Testing. This kit will enable diabetes patients to collect a urine sample at home for mail-in laboratory testing. The urine sample is mailed in a dried state to FlexSite Diagnostics' laboratory using the proprietary UriSite urine collection device. The kit is projected to be available by the first quarter of 2001. This will be the second product in FlexSite Diagnostics' line of at-home mail- in laboratory tests for diabetes management. The first is A1c At Home.

IGEN International, Inc. and Bayer Diagnostics have formed an alliance to develop new products, based on IGEN's TRICORDER diagnostic detection module and Bayer's clinical products, for the hospital point of care testing market. Bayer will provide funding for the alliance.

IRIS, International Remote Imaging Systems Inc. has launched the 939UDx Urine Pathology System for microscopic analysis and urine chemistry testing. The 939UDX, with automated analyte pattern recognition has received FDA clearance to transmit final test results directly to the laboratory computer without operator intervention. The system was designed for medium- to high-volume laboratories.

LabCorp has acquired the National Genetics Institute, Inc. a provider of molecular diagnostic tests. Terms of the stock purchase transaction were not disclosed.

Metrika Inc., has received FDA clearance to market its Digital Response (DRx) HbA1c Patient Monitor, a single-use, quantitative test for long-term glucose monitoring for people with diabetes. The DRx is designed to perform the HbA1c test using a single drop of blood in about eight minutes. The HbA1c percentage of whole blood is shown on the monitor's digital display.

Myriad Genetics, Inc. is developing COLARIS, a predictive medicine test for hereditary colon and uterine cancer. The test is due to launch in September 2000. The test will be used to assess an individual's risk of colon cancer based on the presence of a mutation in either of two genes. The same mutations also substantially increase a woman's risk of endometrial cancer.

Novitron International Inc. has formed an alliance with BioMedica Diagnostics Inc. that involves the technology transfer of a blood clotting detection analyzer and related reagents being developed by BioMedica Diagnostics. Novitron's Dutch unit, Vital Scientific will manufacture the instrument and accessories; BioMedica Diagnostics will make the reagents, and the product jointly distributed by the two companies.

Provalis has received FDA clearance to market its 4-minute test, Glycosal. The test can be used in the doctor's office and measures HbA1c. The product, which has already been launched in parts of Europe, South America and the Far East, will be sold through the company's distributors Bio-Rad Laboratories and Drew Scientific Group.

Roche has agreed to make a financial investment of over $40,000,000 (34% ownership) in TriPath Imaging, Inc. common stock. The arrangement is subject to negotiation of a final agreement, approval under the Hart Scott Rodino Improvements Act and certain other conditions. Roche will purchase 5,000,000 shares of TriPath common stock for $8.00 per share. This transaction is expected to close in September 2000.

Sigma Aldrich Corporation has bought Amelung GmbH of Lemgo, Germany, manufacturer of coagulation instruments. Sigma-Aldrich's Diagnostics Division, which has been the exclusive worldwide distributor of Amelung instruments since 1996, now has full ownership of the research & development, instrumentation, reagents and controls. Sigma has also entered the POC market with the purchase of First Medical, Inc. First medical has developed the Alpha DX, a rapid immunoassay system for cardiac markers. The system has received FDA clearance and is expected to be available for sale early in 2001.

Sybron International Corporation has acquired Lab Vision Corporation, a manufacturer and distributor of automated staining instruments and antibodies used by immunohistochemistry laboratories.
Sybron has also announced that a subsidiary of its Laboratory Products Group has reached an agreement to acquire Abbott Laboratories Murex bacteriology latex agglutination product line. Sybron acquires Abbott's line of latex agglutination bacteriology products including antisera, agglutination reagents, latex reagents and stained suspensions, which are currently manufactured by or for Abbott's Murex subsidiary based in Dartford, England. Abbott will continue to provide manufacturing, distribution and other customer-related functions for Sybron until they are ready to transition the products into their manufacturing and distribution system.

Synthetic Blood International Inc. and UMM Electronics are co-developing Synthetic's implantable glucose biosensor. UMM will be responsible for further development of hardware, software and electronic components of the glucose biosensor, allowing Synthetic to focus on its core biosensing technology.

TheraSense has developed FreeStyle, a blood glucose monitor that allows people with diabetes to obtain a blood sample from the arm instead of the fingertips.

Worldwide Medical Corporation has received FDA clearance to market its FIRST CHECK branded home screening tests for drugs of abuse, in the OTC market. The FIRST CHECK tests receiving 510k clearance include WMED's three primary urine based tests for drugs of abuse, Panel one for marijuana, Panel two for marijuana and cocaine, and Panel three for marijuana, cocaine, and methamphetamine. The FIRST CHECK provides a test result in 8 minutes at home, and customers will also have the option of requesting from Worldwide Medical, a confirmatory test.

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* Product developments - June 2000
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* Product developments - Febuary 2000
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* Product developments - December 1999
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* Product developments - July 1999
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* Product developments - December 1998
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* Product developments - July 1997
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* 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: September 01, 2000