RESPONSE BIOMEDICAL SUBMITS RAMPTM TO FDA
Vancouver, British Columbia, July 5, 2001. Response Biomedical Corp. (RBM:
CDNX) has filed regulatory submissions with the U.S. Food and Drug
Administration (FDA) and the Canadian Therapeutic Products Directorate (TPD)
for market clearance of both its RAMPTM Reader and the first RAMP whole
blood test. Response Biomedical's proprietary RAMP System is easy to use,
cost-effective, and will deliver laboratory comparable results in ten
minutes, thereby saving time, money and most importantly - lives. The first
test for which Response Biomedical is seeking clearance is for myoglobin, a
cardiac marker that is measured to assist in the diagnosis of a heart
attack.
"This submission to the FDA, based on comprehensive data from our recently
completed clinical trials conducted at four sites in the United States,
marks the most significant milestone in the Company's history," stated Bill
Radvak, President and Chief Executive Officer of Response Biomedical. "We
fully expect this achievement, and the anticipated clearance by the FDA in
three to four months, to significantly enhance our discussions with
potential marketing partners."
Testing with RAMP can provide doctors with the information needed to
diagnose and treat heart attack patients before irreversible heart damage or
death occurs. Rapid diagnosis reduces costs associated with unnecessary
hospital admissions including the U.S.$6 billion the American College of
Cardiology estimates is spent annually ruling out heart attack occurrences
in the U.S. alone. RAMP can also aid in reducing the number of patients,
approximately 60,000 per annum in the U.S., who are undiagnosed and have
subsequent heart attacks. In addition to the human cost, these undiagnosed
heart attacks account for approximately 20% of U.S. medical malpractice
awards.
Myoglobin is the first of three RAMP cardiac tests to enter into the
clinical trial phase of commercialization. Recent American Heart
Association guidelines state that patients with suspected acute coronary
syndromes must be evaluated rapidly. Studies have shown that myoglobin
levels are elevated quickly after a heart attack. In addition to
myoglobin, Response is developing tests for two other commonly used cardiac
markers: CK-MB and troponin I. As a group, these three markers are very
effective as aids in the diagnosis of heart attacks, provided that test
results are received in a timely manner.
Another test being developed by Response Biomedical is one for prostate
specific antigen (PSA) to aid in the diagnosis and monitoring of prostate
cancer, the most common cancer in men in North America with over 200,000 new
cases diagnosed annually. Additionally, the Company has demonstrated the
feasibility of RAMP to measure digoxin, one of the most frequently
prescribed drugs in the world used to help to control heart failure. The
Company plans to develop numerous proprietary tests to maximize the utility
of RAMP and participate in the worldwide U.S.$22 billion invitro diagnostic
market.
About Response Biomedical Corp.
Response Biomedical develops quantitative, diagnostic tests for use with its
proprietary RAMP Reader for clinical, STAT-lab and point-of-care
applications. 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. The Company's platform
technology allows for the potential development of over 250 medical tests
that are currently performed by traditional laboratory methods. Response
Biomedical's shares are listed on the Canadian Venture Exchange under the
trading symbol "RBM". For further information, visit the Company's website
at www.responsebio.com
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The Canadian 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.
Company Contacts:
John Gomez
Corporate Communications Manager
Response Biomedical Corp.
Tel (604) 681-4101
Fax (604) 412-9830
Email: jgomez@responsebio.com
Bill Radvak
President & CEO
Response Biomedical Corp.
Tel (604) 681-4101
Fax (604) 412-9830
Email: bradvak@responsebio.com |
