FDA clinical evaluation has begun.
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Response Biomedical Initiates Clinical Trials For FDA
VANCOUVER, BRITISH COLUMBIA--Response Biomedical Corp. (RBM:CDNX) today announced that patient testing has begun in its first multi-center clinical trial of the quantitative RAMP (TM) point-of-care diagnostic system. The results of this study are projected to be submitted to the FDA in June 2001.
Response is enrolling patients at four clinical sites in the U.S. to evaluate the precision of the RAMP System and accuracy of the quantitative myoglobin blood test in patients suspected of having had a heart attack. The clinical sites involved are the University of Maryland Medical Center, Hartford Hospital, Minneapolis Medical Research Foundation at Hennepin County Medical Center, and St. Joseph's Hospital - Franciscan Health System Research Center in Tacoma, Washington.
``This clinical trial is the most significant milestone yet for Response Biomedical'' said Bill Radvak, President and CEO of Response Biomedical. ``Clearance by the FDA will provide validation of the RAMP System and of Response Biomedical's efforts to deliver this exciting new technology to the point-of-care marketplace.''
RAMP is a patented quantitative immunoassay platform that supports healthcare providers in delivering individualized treatment through rapid diagnosis at the point-of-care. In the diagnosis and treatment of heart attacks, more than 6 million patients visit emergency rooms with symptoms of heart attack each year in the United States. Total expenditures on patients who are admitted to hospitals but have not had a heart attack amount to approximately $9 billion annually. Each year approximately 60,000 patients go undiagnosed and subsequently have heart attacks with 25% dying within 24 hours of release from the hospital. Recent American Heart Association guidelines state that these patients must be evaluated rapidly and accurately using cardiac markers, as heart attacks are detectable as early as 2 hours after onset. The RAMP System can cost-effectively deliver quantitative results in less than 10 minutes.
RAMP tests for two additional, widely used cardiac markers, CK-MB and troponin I, are in development and expected to enter clinical trials later this year. The RAMP test menu will be expanded into areas such as critical care, cancer, infectious disease and therapeutic drug monitoring. Response Biomedical recently began development of a Prostate Specific Antigen (PSA) test for Nippon Kayaku of Japan and will also develop a test for ischemia as part of its collaboration with Ischemia Technologies Inc. of Denver, Colorado.
Response Biomedical develops quantitative, point-of-care diagnostic tests for use with its proprietary RAMP System. The RAMP System reduces the cost of healthcare by allowing accurate, rapid and easy-to-use tests to be performed in hospitals, clinics, laboratories and physicians offices worldwide. |
