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.

Abbott Labs has received US FDA clearance to market the Prism System, a fully automated blood testing system designed for high-volume infectious disease testing in blood banks and plasma pheresis centers.

Aksys Ltd has begun clinical studies related to its PHD, Personal Hemodialysis System. FDA a next generation hemodialysis system designed for use at home.

Applied Imaging Corp has purchased the cytogenetic imaging instrumentation business from Vysis Inc. The transaction included Vysis taking approximately a 4% equity stake in Applied Imaging. The two companies will work together to provide mutual customers with a full range of integrated reagent and imaging systems cytogenetic imaging instrumentation. Vysis will focus its resources on its proprietary DNA probe business FISH technology and its newly developed genomic microarray platform, GenoSensor.

Baxter International Inc. has launched its HomeChoice PRO with DPLink, an at-home kidney dialysis system. The system uses advanced computer technology to communicate critical therapy data to clinicians via a data card or modem and thus enables clinicians to monitor patient data on a daily basis, allowing them to adjust prescriptions and identify potential problems between clinic visits.

BioChem Pharma has sold the hematology operations of its diagnostics subsidiary, BioChem ImmunoSystems Inc. to ABX Diagnostics, Inc.

Careside, Inc. has added hematology test options to its proprietary physician office and POC blood-testing system. The hematology component was added through a distribution agreement with CDC Technologies, manufacturers of a hematology diagnostic system. The hematology tests will be electronically linked to the CareSide Analyzer software thus creating a two-component system capable of performing 53 POC blood tests in less than 15 minutes.

Healthcare Technologies' subsidiary, Savyon Diagnostics, has signed an agreement with Carter-Wallace, Inc. for the North American distribution of its urinary tract infection home test product, Uriscreen, under the Carter-Wallace First Response trademark. The product is slated for a year-end introduction. Healthcare's Uriscreen measures catalase, an indicator of both bacteria and/or white blood cells, the key indicators of a UTI.

ChromaVision Medical Systems Inc. has received FDA clearance to market its Automated Computer Imaging System, ACIS. The ACIS combines proprietary, color-based imaging technology with automated microscopy to process existing manual cancer tissue immunohistochemistry testing methods. The FDA clearance obtained is for use of five tumor applications for the ChromaVision ACIS including the detection of cancer micrometastases in bone marrow and sentinel lymph nodes, HER2 protein expression, and estrogen and progesterone receptors in breast cancer and Cytomegalovirus antigenemia.

Gen-Probe Inc. has obtained non-exclusive world-wide rights to use Ambion, Inc's. Armored RNA technology in products and processes for human clinical diagnostic use. Armored RNA technology is a system jointly invented and developed by Ambion and Cenetron for the packaging of RNA in bacteriophage coat proteins to protect and stabilize RNA. A major application for this technology is the production for viral assays of RNA controls and standards that withstand exposure to ribonucleases and long-term storage in serum or plasma.

Diametrics Medical, Inc. recently completed a $9.5 million private equity placement with Hewlett-Packard Company, issuing 1,357,143 shares of its common stock at $7 per share, and warrants to purchase 452,381 shares of common stock at $8.40 per share. The transaction was in conjunction with a marketing and distribution agreement signed in June 1999 providing HP exclusive worldwide distribution rights to Diametrics' IRMA SL blood analysis system, and the Paratrend and Neotrend continuous blood gas monitoring systems.

ID Biomedical Corporation has signed license agreements with Alexon-Trend Inc., a subsidiary of Sybron Laboratory Products Corp. One agreement grants Alexon-Trend the exclusive right and license to manufacture and distribute IDB's Velogene Rapid MRSA Assay (DNA approved) and Velogene Rapid VRE Assay in all countries except for Japan, and the other grants Alexon-Trend a worldwide, non-exclusive license to use IDB's proprietary technology to develop tests to detect gastrointestinal diseases. The Velogene products are based on the IDB's proprietary gene identification technology known as Cycling Probe Technology (CPT). The tests for MRSA and VRE take approximately 90 minutes after primary culture and detect the genes believed to be responsible for antibiotic resistance in these organisms.

Instrumentation Laboratory S.A. has entered into a new ten year strategic alliance and cross distribution agreement with Beckman Coulter, Inc. The new agreement replaces the agreement entered in 1992.

MedcareOnline.com, Inc., a wholly owned subsidiary of MedCare Technologies, Inc. is planning to offer easy-to-use self-administered home-screening tests in collaboration with eBioSafe.com, which has granted MedcareOnline.com worldwide rights. To be made available exclusively through MedcareOnline's health portal, these proprietary tests use micro-sample blood sampling technology. Tests for cholesterol, osteoporosis, prostate cancer, and diabetes health management will be analyzed at CLIA certified BioSafe Laboratories and results will be reported to the consumer through a physician network.

Optiscan Imaging Limited is developing a new generation laser scanning microscope that can immediately diagnose skin cancer without surgical removal. The hand held microscope can magnify skin cancer cells several layers beneath the skin surface 2,000 times without the need for costly and painful biopsies. The microscope is currently being trialed by the Sydney Melanoma Unit at the Royal Prince Alfred Hospital and at several other Australian hospitals and research institutes.

Paradigm Genetics Inc. and Prionics AG are collaborating in the joint development of diagnostics for the rapid detection of Bovine Spongiform Encephalopathy (BSE) in cattle ("Mad Cow Disease") and Creutzfeld-Jakob Disease (CJD) in humans.

Researchers at the University of Utah have unveiled US MedNet, an Internet-based system that allows doctors to match clinical findings with proven treatments. Physicians also can use the system to determine which treatments and medications are covered under their patients' health plans and file electronic claims with carriers and referrals with other physicians.

QIAGEN GmbH and Visible Genetics Inc. will enter into a three-year supply agreement, by which QIAGEN will supply VGI with certain proprietary nucleic acid sample preparation products from QIAGEN's QIAamp product line. VGI intends to market the QIAamp products, in combination with a QIAGEN-developed extension for ultra-low level HIV genotyping, under the name TruPrep.

Genzyme Diagnostics has sold its bioreagent and ELISA immunochemistry product lines to Alexon-Trend Inc.

Vysis Inc. has introduced the new VP 2000 Processor, a comprehensive robotic laboratory instrument that performs specimen deparaffinization and pretreatment. The VP 2000 Processor, together with Vysis' HYBrite Denaturation/Hybridization system, comprise the Modular FISH (Fluorescence In Situ Hybridization) Automation System, allowing high-volume FISH-testing laboratories to automate up to 70% of the labor content and up to 85% of FISH assay steps.

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