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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 Summer 2003

Dear Readers, The summer flew by and as promised here are this summer's news highlights. Our monthly revisions begin in September. Happy Reading and Best Regards, Shara Rosen

AusAm Biotechnologies Inc. has received FDA clearance to market its Microalbumin Plus urine albumin immunoassay.

Axis-Shield has acquired exclusive rights from Abbott to develop 12 new diagnostic assays for the AxSYM system. Axis-Shield expects to begin introducing the new tests in 2005. Previous agreements between Abbott and Axis-Shield have included collaborations on diagnostic tests for Lyme disease, homocysteine (cardiac risk assessment marker) and autoimmune disease.

Bayer Diagnostics has received FDA clearance for its BNP (B-type natriuretic peptide) assay for use on the ADVIA Centaur Immunoassay System. Bayer has also signed a patent and technology licensing agreement with Sontra Medical Corporation. Bayer has been granted exclusive worldwide rights to Sontra's SonoPrep ultrasonic skin permeation technology for the continuous non-invasive glucose monitoring field.

Beckman Coulter, Inc. has introduced its ICON microALB, a CLIA waived point-of-care test for the qualitative detection of microalbumin in urine.

Bio-Rad Laboratories, Inc. has received FDA clearance to market its HIV-1/HIV-2 PLUS O EIA test kit used for diagnostic testing and the screening of blood and blood products. The test simultaneously detects both HIV-1 (Groups M and O) and HIV-2 antibodies.

Biosite Incorporated and Beckman Coulter, Inc. have signed an agreement for Beckman Coulter to manufacture and Biosite to commercialize a b-type natriuretic peptide (BNP) test for use on Beckman Coulter's immunoassay systems. Expected to be available in the first quarter of 2004, the BNP test will be sold worldwide through a combination of Biosite's direct and distributor sales forces.

Boston Biomedica, Inc. has introduced a new Quality Control Product, the ACCURUN 165 West Nile IgM & IgG Positive control.

CalbaTech, Inc. is introducing the FDA approved Qicc, Ltd.'s QiccStain Immunohistochemistry reagents and kits.

Caliper Technologies Corp. and Bio-Rad Laboratories, Inc. have entered into a multi-year product development and commercialization agreement to develop and market a novel microfluidics instrument system for worldwide distribution.

Ciphergen Biosystems, Inc. has established a diagnostic biomarker discovery collaboration with bioMerieux S.A. by which the two companies will work together to discover biomarkers and multi-biomarker panels that may improve the diagnosis and management of colon cancer using Ciphergen's ProteinChip Technology.

CompuCyte Corporation has introduced the iCys Research Imaging Cytometer based on the company's patented LSC laser scanning cytometry technology. The iCys offers automated analysis of cellular specimens in multiple formats, including microscope slides, various types of microtiter plates, and Petri dishes.

Cytyc Corporation has acquired the exclusive world-wide patent rights to products based on Nastech's FDA-approved Mammary Aspirate Specimen Cytology Test. The MASCT is a non-invasive, non-powered device that draws Nipple Aspirate Fluid (NAF) from the breast for cytological examination or molecular analysis.

DakoCytomation has introduced its new virtual microscopy solution ScanScope in partnership with Aperio Technologies. The ScanScope is a microscope slide scanner that can digitize entire slides, creating a virtual slide environment for automated microscopic inspection in pathology, cytology, hematology and related fields.

Deltec has introduced the CozMore Insulin Technology System, an all-in-one smart insulin pump and blood glucose monitoring system. The system combines Deltec's insulin pump with TheraSense's, FreeStyle Blood Glucose Monitoring System.

diaDexus, Inc. has received FDA clearance to market the PLAC test as an aid in predicting an individual's risk for coronary heart disease, in conjunction with clinical evaluation and patient risk assessment. The PLAC test measures the level of lipoprotein-associated phospholipase A2 (Lp-PLA2) in human blood.

Diagnostic Products Corporation has signed a nonexclusive licensing agreement with Abbott Laboratories to market automated Free PSA assays under DPC's IMMULITE and IMMULITE 2000 tradenames. DPC has also sold its PathoDx line of products to Remel Inc. for approximately $4.9 million. The PathoDx line of products consists of manual latex agglutination and immunofluorescent microscopy diagnostic tests.

Diametrics Medical, Inc. has received FDA clearance to market a new cartridge for the measurement of creatinine in blood and to be used with Diametrics' IRMA SL blood analysis system. The cartridge will be commercially available in early 2004.

Focus Technologies has entered into a semi-exclusive agreement with ViroNovative B.V. to provide nucleic acid diagnostic testing for human metapneumovirus (hMPV), a newly discovered human viral respiratory pathogen that causes a spectrum of respiratory symptoms ranging from asymptomatic infection to severe bronchitis.

Galileo Avionica has launched TrimProb, a hand-held, non-invasive testing device for detecting breast cancer, prostate cancer and other kinds of tumors. The device looks like a hand-held metal detector used in airports and can be used while patients are fully clothed. The scanner contains an antenna that produces a beam of microwaves that vary in frequency from 400 to 1350 megahertz.

Home Diagnostics, Inc. has received FDA clearance to market the TrueTrack Smart System, a new blood glucose monitoring system featuring biosensor technology and requires only a one-microliter blood sample.

Hycor Biomedical Inc. is merging with Stratagene. The combined company would offer diagnostic products and life sciences research tool product lines to the global academic, pharmaceutical, and clinical and government laboratory markets. The transaction is expected to close in the fourth quarter of 2003.

Inverness Medical Innovations, Inc. will acquire Applied Biotech, Inc. from Apogent Technologies Inc. Applied Biotech is a developer, manufacturer and distributor of rapid diagnostic products in the areas of women's health, infectious disease and drugs of abuse testing. Inverness has also acquired osteoporosis tests form Ostex International, Inc.

International Technidyne Corporation has entered into an asset purchase agreement to acquire the IRMA (Immediate Response Mobile Analysis) point-of-care blood analysis system product line from Diametrics Medical, Inc. ITC will pay approximately $5 million in cash and assume certain trade payables related to the assets.

Medtronic MiniMed has received FDA clearance to market an insulin pump and glucose monitor system. The wireless system, comprised of a Medtronic MiniMed Paradigm 512 Insulin Pump and a Paradigm Link Blood Glucose Monitor was co-developed with BD (Becton, Dickinson and Company). Medtronic MiniMed has also introduced the CGMS System Gold, an enhanced continuous glucose sensor, which is placed under the skin of a diabetes patient, as well as an external pager-sized monitor that stores continuous glucose readings. Worn by patients for a period of one to three days, the system measures glucose levels every 10 seconds and averages the readings over five-minute intervals.

Radiometer has introduced the TCM 4, a continuous transcutaneous oxygen and carbon dioxide monitor that uses Windows CE and touch screen technology.

Meridian Bioscience, Inc. is beginning production of recombinant Trypanosoma cruzi (Chagas' disease) antigen under a license agreement with Corixa Corporation. The recombinant polyvalent antigen, known as TcF, will be marketed to diagnostic test manufacturers for use in production of test kits for blood bank screening and other diagnostic applications.

Oxoid has launched Oxoid Clear Chromogenic Urinary Tract Infection (UTI) Medium, a new chromogenic medium that is designed to enhance the presumptive identification of the main organisms responsible for urinary tract infections. The medium uses color to differentiate between enterococci, Escherichia coli, coliforms, Staphylococcus aureus and organisms with tryptophan deaminase activity (TDA), such as Proteus, Morganella and Providencia spp.

PANBIO has received FDA clearance to market an immunoassay for the West Nile virus (WNV) disease.

Spectral Diagnostics Inc. has received FDA clearance to market its endotoxin activity assay, which identifies patients at risk for developing severe sepsis on admission to the intensive care unit. Spectral developed the endotoxin activity assay under a joint venture between Sepsis Inc., a subsidiary of Spectral, and Elan International Services Ltd., a subsidiary of Elan PLC.

TCI Optics has received FDA clearance to market OvuLook, a hand-held, reusable microscope that allows women to see a unique pattern in their saliva called ferning. Based on the rise and fall of the hormone estrogen, this ferning pattern looks like frost on a windowpane. This distinctive pattern develops in saliva around the time of ovulation.

Wampole Laboratories, a division of Inverness Medical Inc. has entered into an agreement with Efoora, Inc for exclusive U.S. distribution rights to the Efoora Rapid HIV test. The test uses a simple, 3-step format which provides visually-read, color results using either serum, plasma, whole blood or fingertip whole blood.

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* Product developments - May 2003
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Last modified: September 2, 2003