Canadian Reglatory Clearance
It took a long time, about a year, another step that validates RAMP, another milestone achieved.
Regards - Dick
Response Biomedical Receives Canadian Regulatory Clearance For
RAMPä Heart Attack Test
Vancouver, British Columbia, June 11, 2002. Response Biomedical Corp. (RBM: TSX Venture Exchange) today
announced that it has received clearance from Health Canada's Therapeutic Products Directorate to market the
Company's RAMPä Myoglobin Assay System, a cardiac marker test used with the RAMP Reader in the early
diagnosis of heart attacks.
The proprietary 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 24 hours.
In clinical applications, RAMP is designed to be used by healthcare professionals at the point-of-care, including
physicians' offices, medical clinics, hospital emergency departments and laboratories worldwide. Earlier this year,
the Company announced U.S. Food and Drug Administration (FDA) marketing clearance of the RAMP Reader for
general clinical use, as well as the myoglobin test.
With positive pre-clinical test results for two additional cardiac markers troponin I and CK-MB, the Company is
currently assessing potential clinical trial sites with the goal of filing for regulatory clearance in Canada and the U.S.
by the end of the year.
"Securing regulatory clearance from Health Canada is a milestone event and another important validation of our
technology platform as we prepare for the commercial launch of the RAMP cardiac tests in the first quarter of 2003,"
stated Bill Radvak, President and CEO. "With our sights firmly set on becoming the worldwide leader in the on-site
immunoassay market, as a Canadian company, it is rewarding to gain recognition in our own backyard."
Each year in North America, more than six million people are admitted to emergency rooms for severe chest pain.
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 approximately
$10 billion. In the U.S., misdiagnosed heart attack cases 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, 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.
About Response Biomedical Corp.
Response Biomedical develops rapid on-site diagnostic tests for use with its proprietary RAMP Reader intended for
both clinical and environmental applications, including tests for the detection of heart attack and biological agents
beginning with anthrax.
RAMP is a platform technology that consists of a portable fluorescence reader and disposable test cartridges, with
the potential to be adapted to more than 250 medical and non-medical tests currently performed in laboratories.
On May 29, 2002, the Company announced the commercial launch of the RAMP Anthrax Test - the world's only
reliable rapid on-site detection system capable of distinguishing between a hoax and a potentially infectious dose of
anthrax.
Additional assays under development include tests for the diagnosis and/or monitoring of prostate cancer, therapeutic
drugs and environmental agents including botulism toxin and ricin. Response Biomedical's shares are listed on the
TSX Venture Exchange under the trading symbol "RBM". For a photo of the RAMP System and/or further
information, visit the Company's website at www.responsebio.com.
The TSX Venture Exchange has not reviewed and does not accept responsibility for the adequacy of the content of the information contained
herein. The statements made in this press release may contain certain forward-looking statements that involve a number of risks and
uncertainties. Actual events or results may differ from the Company's expectations.
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Media Contact: Investor Contact:
Don Bradley John Gomez
Director, Corporate Communications Manager, Investor Relations
Response Biomedical Corp. Response Biomedical Corp.
Tel (604) 681-4101 ext 202, Cell (604) 961-3883 Tel (604) 681-4101 ext 208 |
