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.

Agenix subsidiary, AGEN BioMedical, and Biosite Inc. have signed a license and supply agreement for D-dimer. Biosite intends to incorporate AGEN's 3B6 antibody, specific for D-dimer, into its Triage Profiler S.O.B. Panel to identify the cause of shortness of breath, a symptom common to congestive heart failure, heart attack and pulmonary embolism. The S.O.B. Panel measures, BNP, D-dimer, myoglobin, CK-MB, and troponin I.

artus GmbH and Abbott Laboratories have introduced three real time PCR tests designed to run on the Applied Biosystems ABI PRISM 7000 Sequence Detection System - the RealArt HPA Coronavirus PCR Kit, RealArt C. trachomatis PCR Kit, and the RealArt M. tuberculosis PCR Reagents. All three tests are available worldwide, except in the US, Canada and Japan.

Ciphergen Biosystems, Inc. is developing a biomarker pattern for the diagnosis of Alzheimer's Disease. The array analyzes CSF proteins using Ciphergen's SELDI ProteinChip Biomarker System and Expression Difference Mapping methodology.

DiagnoCure has assigned to Gen-Probe the exclusive license for its urine gene PCA3(DD3) test for prostate cancer. The gene has been shown to be over-expressed only in malignant prostate tissue. Gen-Probe will pay DiagnoCure an upfront US $3 million fee, and future fees and contract development payments of up to US $7.5 million over the next three years and will pay DiagnoCure royalties of 8% on cumulative net product sales of up to $50 million, and royalties of 16% on cumulative net sales above $50 million.

Focus Technologies has received FDA clearance to market its IgM and IgG ELISA antibody detection diagnostic kits based on a West Nile Virus recombinant protein antigen licensed by the Centers for Disease Control and Prevention.

International Remote Imaging Systems, Inc. has entered into a distribution relationship with ARKRAY, Inc., for the AUTION JET AJ-4270, urine chemistry analyzer and related products designed for decentralized locations around the hospital, including emergency rooms and satellite labs.

Leica Microsystems Inc. has entered into an alliance with Sigma-Aldrich Corporation to distribute histology and cytology stains and reagents in the US for the medical, pharmaceutical, biotechnology and academic sectors.

NetImpact Holdings, Inc. has introduced its MDS 200, a POC instrument that utilizes samples of blood, saliva, sweat or urine to identify numerous diseases. The first shipments are targeted for Mali, Singapore, Vietnam, China and Mexico.

Oxoid Limited has launched a rapid test for the direct detection of antibodies to E. coli O157 Lipopolysaccharide in serum. The Oxoid O157 Check LPS Antibody Kit (DR0190M) is a latex agglutination test with results in 3 minutes.

QT 5, Inc. has acquired the exclusive worldwide rights to a blood and urine POC test platform designed for the Homeland Defense market. The platform incorporates a solid phase membrane and immunologically based reagents in a single-use disposable test device. The current product line includes a blood tests that have already received FDA approval including rubella, herpes virus, rotavirus, strep group A, infectious mononucleosis and early pregnancy. A 10-minute HIV1 and HIV2 test, cardiac markers and drug tests are in the pipeline.

Tomen America Inc. and Nippon Kayaku Co. Ltd. have received FDA clearance to market the GlycoMark test that measures the level of 1,5-anhydroglucitol (1,5-AG) for the intermediate term monitoring of glycemic control in people with diabetes. The marker reflects average glucose levels over a period of a few days to 2 weeks.

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