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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 December 1999

Abbott Labs has increased its equity position in SpectRx Inc. by purchasing $2.75 million in convertible redeemable preferred stock and is expected to make an additional $2.5 million convertible redeemable preferred stock investment in SpectRx on January 3, 2000 SpectRx, Inc. This is part of an agreement that includes joint development of a continuous glucose monitor based on SpectRx's non-invasive biophotonic technology.

Array Medical has received FDA clearance to market Plateletwork, bedside platelet aggregation technology used on the Ichor hematology analyzer. The Plateletworks technology is used to screen for trends suggestive of platelet dysfunction during interventional cardiac procedures.

Atherotech has developed a new cholesterol test, the "VAP " or Vertical Auto Profile test that measures known risk indicators, helping identify patients at risk, allowing for preventative treatment. The is available globally and is currently reimbursed by more than 300 insurance companies, including Medicare. All VAP Test samples are processed at the Atherotech laboratory.

Avocet Medical, Inc. has received FDA clearance to market its AvoSure PT System for consumer prothrombin time self-testing.

Cholestech has launched its POC ALT, liver function test cassette to be used on the Cholestech LoDoX System. Cholestech's ALT cassette has a list price of $4.50 per cassette.

Ciphergen Biosystems, Inc. and the National Cancer Institute are developing Ciphergen's ProteinChip System, which integrates patented SELDI (Surface Enhanced Laser Desorption/Ionization) mass spectrometry and biochip technologies on a single platform. The system will test for twelve protein biomarkers for benign prostatic disease and six protein biomarkers for prostate cancer.

CompuCyte Corporation and Genetics Institute Inc., a unit of Wyeth-Ayerst Laboratories, the pharmaceutical division of American Home Products Corporation are developing cell-based assays to be performed on CompuCyte's new diagnostic system, OnCyte for rapid monitoring of the effects of GI's cell adhesion inhibitors currently in clinical development. Cell adhesion inhibitors act to reduce leukocyte/platelet and leukocyte/endothelial interactions that mediate the primary and secondary pathology of vascular and inflammatory diseases. OnCyte is a new, 'near-patient' system for cellular analysis.

The GlucoWatch, made by Cygnus Inc. has received clearance to market from the FDA advisory panel. Cygnus said it has not finalized the price for GlucoWatch, but it might be sold to patients for between $225 and $250, with sensors that last up to 12 hours costing $4 each

Digene Corporation has received marketing clearance from the FDA for its Hybrid Capturer II Gonorrhea Test for the detection of neisseria gonorrhea DNA in cervical specimens. The test is indicated for use in women, with or without symptoms of infection, to identify or confirm the presence of Gonorrhea. Abbott Laboratories distributes Digene's Hybrid Capture II Gonorrhea Test in Europe, Africa, and the Middle East, and will distribute the Digene GC Test in the United States.

InMedica Development Corporation has designed a patented technology for the non-evasive hematocrit monitoring device. and explained many of the monitor's uses. The device has been developed by InMedica through its wholly-owned subsidiary, MicroCor, Inc. It measures hematocrit quickly and non-invasively through the finger using electrical impedance.

Labsystems Oy, a Thermo Electron company has signed a non- exclusive worldwide agreement with Ortho-Clinical Diagnostics to develop and manufacture automated sample-transport and analysis systems for Ortho's Vitros analyzers.

Third Wave Technologies, Inc. has introduced a second set of Invader technology-based analyte specific reagents and assay controls for routine clinical use for the detection of a mutation in the Factor II (prothrombin) gene which is associated with deep vein thrombosis, pulmonary embolism and other potentially life threatening conditions. Third Wave already has

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* Product developments - November 1999
* Product developments - October 1999
* Product developments - September 1999
* Product developments - August 1999
* Product developments - July 1999
* Product developments - June 1999
* Product developments - May 1999
* Product developments - April 1999
* Product developments - March 1999
* Product developments - Febuary 1999
* 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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