You were right, Dick. FDA approval for RAMP. This is a major milestone completed.
biz.yahoo.com
Response Biomedical Receives FDA Clearance for Ramp(TM); New Diagnostic System Delivers Reliable Results in Minutes
VANCOUVER, BRITISH COLUMBIA--Response Biomedical Corp. (RBM: CDNX) announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market the Company's RAMP(TM) Reader and RAMP Myoglobin Test, used for the rapid diagnosis of heart attacks. The RAMP System is easy to use, cost effective, and delivers reliable results in less than 15 minutes, considerably faster than traditional laboratory testing often limited by turnaround times of up to twenty-four hours.
The RAMP System, consisting of a portable fluorescence reader and disposable test cartridges, is designed to be used by healthcare professionals at the point-of-care, including physicians' offices, medical clinics, hospital emergency departments and laboratories worldwide. With the reader cleared by the FDA for general clinical use, the Company can leverage its significant research and development investment into a diverse pipeline of products. Additional tests under development include two other cardiac markers as well as tests for the diagnosis and/or monitoring of prostate cancer, therapeutic drugs and environmental agents such as anthrax.
``FDA clearance validates the performance of the system, providing a level of assurance that RAMP will play an important role in both the clinical and environmental testing fields,'' stated Bill Radvak, President and CEO of Response Biomedical. ``We expect the achievement of this historic milestone to immediately impact our finance and business development efforts. With preliminary discussions underway, we anticipate heightened interest from top-tier potential marketing partners in the coming weeks and months. We look forward to turning a leading-edge technology opportunity into a profitable business.''
The RAMP Cardiac Tests
Each year in the United States, more than six million Americans are admitted to emergency rooms for severe chest pain, according to the American College of Cardiology. Only approximately 10% of those hospitalized suffer a heart attack. The vast majority are eventually diagnosed with strained muscles, bruises or heartburn. The total cost of unnecessary admissions and misdiagnosis is over US$6 billion. Misdiagnosed heart attack cases also account for nearly 25% of malpractice claims against emergency room physicians.
The RAMP Myoglobin Test provides a quantitative measurement of myoglobin levels in a whole blood sample. Myoglobin is one of three commonly utilized cardiac markers measured to assist in the diagnosis of acute myocardial infarction (heart attack). Studies have determined that elevated levels of the cardiac markers myoglobin, CK-MB, and troponin I in blood, indicate the occurrence of heart attack. As myoglobin is the first marker to be released into blood following a heart attack, it is a valuable early screening test. Tests for troponin I and CK-MB are in late stage development.
The RAMP Anthrax Test
To capitalize on the versatility of the RAMP platform and produce near term revenues, the Company is fast-tracking the commercialization of a RAMP test in 2002 for the on-site determination of Anthrax. The proprietary test produces reliable results within 15 minutes, considerably faster than conventional laboratory testing, and has a higher level of sensitivity than currently available on-site tests. Although FDA clearance is not required for the RAMP Anthrax Test, it lends significant credibility as the RAMP System has met a higher standard than currently available rapid environmental screening tests. |
