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 December 2004
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Applied NeuroSolutions, Inc. and bioMerieux, S.A. signed a non-exclusive agreement to develop a definitive biologic test for the diagnosis of Alzheimer's disease. The companies will co-develop a serum test based on Applied NeuroSolutions CSF technology.
Biosite Incorporated received FDA clearance to market the Triage D-Dimer Test. a rapid test intended to be used as an aid in the assessment and evaluation of patients suspected of having thromboembolic events, including pulmonary embolism. Product shipments are expected to commence in the U.S. in February 2005.
Cellestis Inc. received FDA clearance to market the QuantiFERON-TB GOLD, an indirect test for M. tuberculosis infection. The serum test detects immune responses to specific proteins, associated with tuberculosis (TB) infection and is targeted to replace the 114-year-old tuberculin skin test. The assay measures gamma interferon, a protein that indicates an immune response. The technology was first approved for TB by the FDA in 2001.
Dade Behring acquired semi-exclusive diagnostic rights for the commercialization of automated diagnostic tests using myeloperoxidase (MPO).developed by The Cleveland Clinic. MPO has been reported to be useful for identifying inflammation in the walls of coronary arteries, which in turn may indicate a risk for heart disease or heart attack. The MPO test will be added to the company's cardiac panel - NT-proBNP, hsCRP and Troponin I.
Gen-Probe received FDA clearance to market its APTIMA Chlamydia Trachomatis (CT) assay, an amplified nucleic acid test on a standalone basis. With this assay Gen-Probe offers two nucleic acid tests that detect different parts of the CT genome.
LifePoint, Inc. received FDA clearance to market the LifePoint IMPACT Test System in conjunction with the opiate test (morphine and heroin) for use in medical markets.
Ortho Biotech Products, L.P. launched FDA cleared AnemiaPro a home test for anemia-screening test, targeted for people at significant risk for anemia from chronic kidney disease. The test was developed by BIOSAFE Medical Technologies, Inc.
Surescreen Diagnostics Ltd. launched its Chlamydia Wand, CE marked for clinical use and home use.
ThyroTec Inc. received FDA clearance to market and CLIA waiver status for its ThyroTest, a rapid, whole blood test for TSH.
Product developments - November 2004
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Last modified: January 3, 2005