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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 May 2000Agilent Technologies Inc. has acquired Zymed Inc., a provider of cardiac analysis software algorithms, inpatient telemetry systems, outpatient holter systems, and cardiac event monitoring systems. The acquisition complements Agilent's portfolio of cardiology devices. American Bio Medica Corp. has filed an application with the FDA for clearance to market its Rapid Drug Screen line of on-site drug test kits through OTC sales channels. The test will join the Drug Detector system launched for OTC markets January 2000. American Biogenetic Sciences, Inc. and Trevigen, Inc. are developing a test to measure DNA damage which will be sold by Trevigen to biomedical researchers involved in research on DNA damage and repair. ABS will receive a royalty on all commercial products developed from this collaboration as well as maintaining manufacturing rights for the antibodies. Applied Imaging Corp. has filed a 510(k) application with the FDA for its new SlideScan system to detect micrometastic cells in bone marrow specimens that have been identified using immunohistochemical techniques. The SlideScan system is the clinical version of the company's MDS image analysis platform. Avitar, Inc. has launched ORALadvantage, a drug testing program for small businesses that offers saliva-based, on-site testing. The product features ORALscreen 4 to detect traces of marijuana (THC), cocaine, opiates and methamphetamine with results in minutes. ORALadvantage, costs $595.00 and includes substance abuse policy development tools and templates, employee education videos, and information on Employee Assistance Program resources as well as twenty ORALscreen 4 devices, sample collection kits for lab-based confirmation testing, chain of custody and consent forms, and alcohol screening tests. Bayer Diagnostics has completed its Premarket Approval Application (PMA) to the FDA for approval of its HIV-1 RNA 3.0 Assay (bDNA), viral load test for HIV. The test was developed by Chiron. BIOSAFE Diagnostic Products, Inc. has introduced BIOSAFE PSA4, a home test for prostate cancer screening. BIOSAFE PSA4, is a laboratory analysis of PSA from a dried blood sample that can be self-collected by the patient and sent to BIOSAFE Laboratories, Inc. for analysis using the Hybritech Tandem-MP PSA assay. The test is available by phone at 1-888-700-TEST, or from the company's Web site at www.psa4.com and costs $24.95. Calypte Biomedical Corporation has launched its Sentinel urine testing service for HIV-1, chlamydia, and gonorrhea DNA tests throughout the United States. Results generally are reported three days after the sample is received by the lab. Cepheid and Infectio Diagnostic (I.D.I.) Inc., have formed a joint venture, ARIDIA Corp. (Automated Rapid Identification and Detection of Infectious Agents)to commercialize products based on Cepheid's proprietary systems for automated sample preparation, analysis, and detection, and IDI's extensive portfolio of proprietary molecular diagnostic reagents and methods. ARIDIA is developing tests for bacterial and fungal infections, including Group B strep, antibiotic resistant bacteria, meningitis, Candida and septicemia. Corgenix Medical Corporation has received FDA clearance to market a test that detects IgA antibodies to phosphatidylserine. High levels of these antibodies have been reported in patients with antiphospholipid syndrome and characterized by recurrent thrombosis, thrombocytopenia and fetal loss. This test complements two Corgenix products previously cleared by the FDA, the IgG and the IgM anti-phosphatidylserine test kits.
PharmaNetics, Inc. has received approval from the FDA for a Humanitarian Device Exemption (HDE) for the Ecarin Clotting Time Test (ECT). The approval covers the use of the test for managing patients suffering from heparin induced thrombocytopenia who receive Refludan while undergoing cardiopulmonary bypass. HDE approval is an accelerated authorization process to market devices used in rare disease states where no existing solution is available. Biocontrol Technology, Inc. has received CE Mark approval for the Diasensor 2000 Noninvasive Glucose Monitor, which has software and hardware improvements over the Diasensor 1000 model. The CE Mark signifies that the product meets mandatory health and safety standards for medical devices set by the European Union. Epitope Inc. has purchased STC Technologies for about $200 million in stock in order to form a new company called OraSure Technologies. International Remote Imaging Systems Inc. (IRIS) has received FDA clearance to market the fully automated 939UDx Urine Pathology System that integrates the Roche Hitachi CHEMSTRIP Super UA Urine Analyzer for urine test strip chemistries, the IRIS imaging flow cytometer for capture of particle images and a neural network image recognition technology for urine particle analysis. MicroSense International, LLC is developing the non-invasive glucose detector Pushita. Myriad Genetics, Inc. and Hitachi Ltd. have formed a strategic alliance to market Myriad's proprietary high-throughput proteomic screening technology, ProNet in Japan. Ostex International has acquired the exclusive right, from Metrika, to manufacture the Osteomark NTx Point-of-Care device to monitor changes in bone breakdown for the management of osteoporosis. The Company also obtained an exclusive worldwide license to manufacture, market and sell this device for the measurement of other connective tissue markers, including those associated with arthritis. Point of Care Technologies, Inc. will acquire MonoGen, Inc., developer of the microscopic slide preparation known as the MonoPrep System; Mission Medical Inc. which has developed fully automated blood collection and separation products designed for blood banking procedures; and Baseline Technologies Inc., and information technology company. Response Biomedical Corp. has won a contract from Battelle to develop a quantitative point-of-care digoxin assay using its patented Ramp technology. Trek Diagnostic Systems, Inc. has been awarded the assets of Combact Diagnostic Systems, Ltd. developer of a fully automated, FDA cleared, instrument, Cellenium 160US, that combines selective fluorescence staining with computerized video image analysis to perform rapid urine screening for bacteria. In addition, TREK and Savyon Diagnostics, Ltd. have signed an agreement giving TREK exclusive US distribution rights for the onSite urine culture device.
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