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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 1999

American Biogenetic Sciences is launching clinical trials of its point of care version of its proprietary thrombus precursor protein (TpP) test to detect blood clot formation in conditions such as myocardial infarction, deep vein thrombosis and pulmonary embolism. The clinical testing is an essential step prior to submission to the U.S. Food and Drug Administration for marketing clearance. The laboratory version of TpP is already FDA approved.

Biopool International is selling its blood-bank reagent business to Immucor. The BCA Division had been purchased from Organon Teknika in 1998. The purchase price is $3.0 million for net working capital plus $1.5 million for the product lines. Immucor has been consolidating the blood bank business through their acquisition of Dominion Biologicals Ltd. in 1997 and, more recently, by acquiring Gamma Biologicals in November 1998. This consolidation leaves only two players in blood banking Immucor and Ortho Clinical Diagnostics.

Bio-Rad Laboratories has acquired the hereditary hemochromatosis portfolio from Progenitor, Inc. including all of Progenitor's patents and patent applications covering the hemochromatosis gene and its specific mutations along with procedures for using these molecular markers to detect the presence or absence of the gene.

Calypte Biomedical and Carter-Wallace, Inc. have signed a letter of intent which will give Carter-Wallace the exclusive U.S. sales and marketing rights for Calypte's HIV products in the hospital, public health and reference lab markets. Calypte manufactures the only two FDA-licensed urine HIV-1 antibody screening EIA and supplemental Western Blot tests.

Dade Behring and Sysmex Corporation have renewed their exclusive global alliance for marketing coagulation products. The agreement extends a four-year relationship between the two companies.

Integ Incorporated and Amira Medical have entered into a strategic alliance to jointly develop a new generation of ISF-based home glucose monitoring tests Integ's interstitial fluid collection technology with Amira's glucose measurement technologies. Amira recently introduced the FDA approved AtLast home blood glucose testing system.

Ortho-Clinical Diagnostics recently received FDA clearance for ten new assays including tests for phenobarbital, HDL, alpha-fetoprotein, testosterone, N-telepeptide (NTx), vitamin B12 /folate, PSA), CA 15-3 and cortisol.

The FDA has approved Roche Molecular Systems' Investigational New Drug (IND) application by Roche Molecular Systems' for the COBAS AmpliScreen HCV Test, Version 2.0, RMS can now begin its clinical trial with America's Blood Centers.

Shield Diagnostics will give CV Technologies access to its parathyroid hypertensive factor (PHF) technology. PHF, a hormone discovered by CVT scientists, is associated with several calcium dysregulation disorders, including low renin and salt sensitive hypertension and type 2 diabetes. High levels of PHF in the blood indicate that the hypertensive patient may respond to calcium channel blocker therapy and diuretics or could be managed by dietary salt restriction, whereas low PHF patients may respond best to ACE inhibitors and Beta-blockers.

SIBIA Neurosciences has entered into a non-exclusive license agreement with SmithKline Beecham for access to its drug screening method, transcription-based assay (TBA), a functional cell-based assay which provides an indirect measure of the activity of certain cell surface molecules.

Epitope has entered into an agreement with Organon Teknika Ltd. of Dublin, Ireland, for the development and manufacture of Epitope's OraQuick oral fluid rapid assay for the diagnosis of HIV. OraQuick is a one-step, rapid-format oral specimen testing system designed to provide test results within ten minutes. Columbia Metals Corporation Enters Into Agreement

Columbia Metals Corporation Limited has formed a private company, POC-KIT Corporation, for the development of a POC biochip platform technology, the DIAPRO POC-KIT System. The DIAPRO BioChip measures the level of disease specific immunodiagnostic markers.

Home Access has received FDA clearance to market its Home Access Hepatitis C Check(SM) Service, an at-home test for hepatitis C. The service will be available in June 1999 via the company's website at www.homeaccess.com or by calling 1-888-888-HEPC. The retail price is expected to be under $70.

Olsten Health Services Managing Primary Distribution of Avocet Prothrombin Time Monitor

Olsten Health Services, a health care company has begun providing primary distribution and support services for the Avocet PT-Pro, a hand-held diagnostic device manufactured by Avocet Medical, Inc. that measures prothrombin time. Avocet received FDA 510(k) clearance November 1998 for professional use of the device. The AvocetPT-Pro, is a hand-held electronic meter that reads a disposable reagent strip. A home-use 510(k) submission is currently pending with the FDA.

VWR Scientific Products has made a 10% equity purchase of Chemdex Corporation, a provider of electronic commerce solutions for the laboratory research market. VWR and Chemdex will partner to create an Internet-based one-stop shop for lab supplies.

Bio-Rad Laboratories and Saigene Corporation have signed a worldwide exclusive licensing agreement to commercialize genetic markers associated with insulin-dependent diabetes. People who have these markers can have up to 100 times increased risk of contracting insulin-dependent diabetes mellitus in their lifetime.

Avitar, Inc. has launched its OralScreen 3-panel oral fluids test for marijuana, cocaine, and opiates. The test utilizes oral fluids as the test sample rather than urine and provides a screening test in ten minutes. In addition to the 3-panel test, the OralScreen line also includes a single test for morphine, heroin and other opiates. The test will be available for sale in selected markets in the near future.

Becton Dickinson and Company has acquired Clontech Laboratories, Inc. a privately-held company serving the life sciences market in the areas of gene-based drug discovery technology and molecular biology research. The companies expect to complete the transaction by June 30, 1999.

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* 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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