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The following is a review of diagnostic product developments worldwideThe 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.
Product developments in April 2001
Abbott Laboratories has increased its involvement with SpectRx Inc.'s continuous glucose monitoring program. Abbott will also make a $2 million milestone payment in the form of an equity investment in SpectRx's stock before Aug. 31, 2001. Under a 1999 agreement, Abbott has worldwide marketing rights to SpectRx's interstitial fluid glucose monitoring technology. Abbott Laboratories has entered into an agreement with Vysis, Inc. for the worldwide distribution of two genomic tests to assist in the management of breast and bladder cancer. The agreement gives Abbott exclusive distribution rights in North America and Europe for Vysis' DNA-based cancer tests: PathVysion HER-2 assay, used to detect and quantify the HER-2 gene in breast cancer patients, and the UroVysion assay, which detects genetic changes in bladder cancer cells found in the urine. The agreement also gives Abbott an exclusive option for distribution rights in Asia/Pacific (except Japan) and South America for both assays. American Biogenetic Sciences Inc. has licensed its Thrombus Precursor Protein diagnostic marker and antibodies to Biosite Diagnostics Inc. for potential use the Triage meter. The TpP diagnostic is approved for use in aiding in the risk assessment of thrombosis and the monitoring of heparin therapy. AmeriPath, Inc. and Genomics Collaborative, Inc. have entered into an alliance whereby GCI granted AmeriPath an option to license select molecular markers for diagnostic applications. The first option relates to a diagnostic marker useful in the prognosis of breast cancer. Careside Inc. has granted Fisher HealthCare distribution rights for its point-of-care testing products. The agreement is the latest in a series of national and regional distribution contracts for Careside and marks the company's introduction of its the physician office lab and acute-care markets. Cholestech Corp.'s ALT test, for the Cholestech L.D.X System has received CLIA waived status. The company plans to launch the ALT liver function test on June 1. The product's list price is $45.00 U.S. for a box of 10 cassettes. Corgenix Medical Corp. has received FDA clearance to market two new test kits for the diagnosis and risk assessment of certain cardiovascular disorders characterized by blood clot formation. The tests, IgG anti-Prothrombin and IgM anti-Prothrombin, detect key markers in the blood of patients who are at risk of developing clinical thrombosis. These two new tests brings the company's antiphospholipid product line increases to eleven. eScreen, Inc. has received FDA clearance to market the eScreen Drugs of Abuse Screening System that provides negative results within minutes. eScreen's system includes the eCup and eReader that reads the test results automatically. Cbr has launched NewScreen Expanded Newborn Screening. The system uses tandem mass spectroscopy to detect many fatty acid oxidation disorders which may comprise up to 5% of SIDS cases. NewScreen uses a blood sample taken at the same time as a newborn's routine "heel-stick" in the first few days of life. NewScreen is available for less than $100. Ortho Clinical Diagnostics has received FDA clearance to market its Vitros Anti-HBs assay designed for the Vitros ECi Immunodiagnostic System. OxisResearch, a division of OXIS Health Products, Inc. has introduced the Catalase-520 assay system. The test joins the SOD-525, GSH/GSSG-412, GPx-340 and GR-340 assays in the area of antioxidant biomarker analysis. Catalase is being evaluated in the treatment of skin disorders and wounds and has broad application in age-related studies. TCPI, Inc. has acquired the European distribution channels, certain trademarks and business assets related to the EVATEST (pregnancy), EVAPLAN (ovulation) and other similar trademarked OTC family planning products currently marketed by Roche Diagnostics GmbH. TCPI was also seeking to acquire the related business assets in South America. Third Wave Technologies, Inc. has launched an Invader reagent set specific for the A1298C mutation in the methylene tetrahydrofolate reductase (MTHFR) gene. Third Wave previously released a reagent set specific for the C677T mutation in the MTHFR gene. These mutations have been associated with hyperhomocystinemia and linked to the development of deep vein thrombosis. Trinity Biotech plc has received additional clearance from the FDA for its CAPTIA Syphilis, to be used as a diagnostic aid to provide serological evidence of syphilis infection. The test for T. pallidum is an automatable EIA. Trinity offers a range of syphilis tests including fluorescence, EIA, and western blot. Vysis, Inc. has received FDA clearance to market its AneuVysion prenatal testing product allowing immediate reporting of test results. The previous medical policy indicated that test results based on Fluorescent In-Situ Hybridization be withheld until routine cytogenetic test results were also available, generally 7-10 days later, except in medically urgent situations. This new use of the Vysis AneuVysion prenatal test, allowing immediate use of results.
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