The following is a review of diagnostic product developments worldwide

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.

Avitar has introduction its OralScreen 3-panel oral fluids test for marijuana, cocaine, and opiates. The test utilizes saliva 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 will acquire Clontech Laboratories, Inc., in a stock-for-stock exchange valued at approximately $200 million. Clontech Laboratories, Inc., is 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. Clontech's strong molecular biology position is complementary to BDB's position in immunology and cell biology.

Dade Behring and HemoSense have concluded an agreement to collaborate on HemoSense's new generation of POC diagnostic analyzers for monitoring blood clotting. The HemoSense system is designed for use in the home and in physician offices to measure prothrombin time in patients taking oral anticoagulant medications. The system consists of a low-cost meter and disposable test strips.
Dade Behring has made a substantial equity investment in HemoSense and acquired a seat on the company's board of directors.

Home health care company Olsten Health Services has agreed to provide distribution and support services for the Avocet  PT-Pro, a hand-held diagnostic device manufactured by Avocet Medical, Inc. that measures prothrombin time in patients receiving anticoagulant therapy. Avocet received its first U.S. Food and Drug Administration 510(k) clearance late last year for professional use of the device. The Avocet PT-Pro has been designed to be smaller, easier to use and significantly less expensive than competing technologies, while delivering industry leading accuracy and performance. Avocet anticipates that FDA clearance for marketing the device to consumers for self-testing in the home environment will be granted in the near future. A home-use 510(k) submission is currently pending with the FDA.

AVL Medical Instruments has announced the addition of BUN to the panel of measured parameters on the AVL OMNI Modular System. A fully automatic analyzer, the OMNI already measures a wide range of critical care parameters, including blood gases, electrolytes, CO-Oximetry, glucose and lactate. With the addition of BUN, the AVL OMNI is the only whole blood analyzer on the market that can provide this wide test menu in one analyzer. The BUN measurement is performed using state of the art planar "thick film sensor" technology which offers the advantages of: no membranes, zero maintenance, low cost, small sample requirement, excellent throughput and interference-free measurements.

Immucor has announced an agreement with Mediware Information Systems, Inc. to interface Mediware's Hemocare and LifeLine Blood Bank Information systems with Immucor's ABS2000 and Rosys Plato products.

Varian, Inc. has introduced the ProStar Helix system offering a rapid and economical method of performing DNA analyses, The HPLC system is specially optimized for the ultrafast separation of DNA fragments by size and for the discovery and screening of DNA mutations.

Cardiovascular Diagnostics, Inc. has received FDA clearance to market for the Electronic Quality Control (EQC) test card and for a new software upgrade for the Thrombolytic Assessment System (TAS). The Company now has FDA clearance for over fourteen devices and tests with eighteen other tests in the development pipeline. This software increases data communication potential permitting the TAS instrument to provide patient data throughout a hospital or clinic using Bayer Diagnostics' Rapidlink Critical Care Information Systems.

Ciphergen Biosystems, Inc. has introduced its ProteinChip System, Series PBS II. The system enables researchers, at the benchtop, to detect and analyze trace amounts of proteins directly from biological tissues and fluids, including proteins differentially expressed in disease. The ProteinChip system can be used to rapidly clarify basic biology problems, identify disease markers and drug targets, and aid drug and diagnostic discovery. The company will market the product to research groups in the pharmaceutical and biotechnology sectors, as well as in government and academia. In as little as a day, researchers can locate, identify and characterize disease-related proteins from biological fluids and tissue, and proceed immediately to analyze protein function -- all on the chip.

Integ Inc has formed a strategic alliance with Amira Medical that will accelerate development of the LifeGuide System. The alliance combines Integ's ISF collection technology with Amira's measurement micro-technology. The design of the first prototype system integrating these two technologies is nearly complete and the company will begin testing using this system in the second quarter.

A-Fem Medical Corporation has developed the A-Fem PadKit Sample Collection System designed as a non-invasive alternative to the cervical scrape for cervical cancer screening. Pilot study results support the concept that the PadKit's self-collected sample may serve as a clinical alternative to the conventional cervical scrape providing a viable sample for cervical cancer screening. The PadKit collects atypical cells including ASCUS, LSIL and HSIL and cell morphology is well preserved.

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