Response Biomedical Receives US FDA Clearance for RAMP(R) NT-proBNP Test for Diagnosis...

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Tue Jul 22, 2008 8:25am EDT

Response Biomedical Receives US FDA Clearance for RAMP(R) NT-proBNP Test for
Diagnosis of Heart Failure

VANCOUVER, July 22 /PRNewswire-FirstCall/ - Response Biomedical Corporation
(TSX: RBM, OTCBB: RPBIF) announced that it has received regulatory clearance
from the U.S. Food and Drug Administration (FDA) to market the RAMP(R)
NT-proBNP Test as an aid to the rapid diagnosis of heart failure (HF).
"NT-proBNP is emerging as a superior marker for the diagnosis of heart
failure," said S. Wayne Kay, Chief Executive Officer. "The introduction of the
point-of-care RAMP(R) NT-proBNP Test is a significant advance as it supports
the drive for speed and accuracy of diagnosis for patients presenting in
emergency rooms and for early detection in ambulatory care. Because the
performance of our RAMP(R) NT-proBNP Test is clinically concordant with that
of the Roche Elecsys proBNP Test, a hospital can have standardized clinical
decision points for NT-proBNP in both their emergency rooms and central
laboratories. The addition of the innovative NT-proBNP Test expands the menu
of the RAMP200 analyzer for the rapid assessment of patients with symptoms of
cardiovascular disease."
Dr. James L. Januzzi, the Director of the Coronary Care Unit at Massachusetts
General Hospital expressed his enthusiasm for the imminent introduction of the
RAMP(R) NT-proBNP Test. "As the first full range point-of-care assay for
NT-proBNP, the RAMP(R) Test will present a major step forward for rapid and
confident diagnosis of heart failure using this important blood test. Clinical
trials, including studies done at the Massachusetts General Hospital, have
shown that the RAMP(R) result can be used interchangeably with results from
automated NT-proBNP Tests done in the hospital laboratory. This harmony
between the RAMP(R) and the automated NT-proBNP Tests represents a huge
advantage over most point-of-care BNP assays, which have disappointing harmony
with their automated counterparts."
Response Biomedical recently announced a partnership granting rights to Roche
Diagnostics, a world leader in clinical diagnostics, to market its line of
cardiovascular point-of-care (POC) tests. Roche Diagnostics' comprehensive
sales and marketing infrastructure allows for broad worldwide penetration of
Response Biomedical's cardiovascular line.

About HF

HF impedes the ability of the heart to pump blood at a rate sufficient to
support the body's vital needs. HF affects nearly 17 million people worldwide,
and is the single most frequent cause of hospitalization in people over
65 years. The initial diagnosis of HF is problematic as symptoms can be
associated with other pathologies such as respiratory disease and the
secondary effects of obesity. According to the Canadian Heart and Stroke
Foundation, doctors estimate that there are 200,000 - 300,000 Canadians with
heart failure. Since 1970, the number of Canadians dying from congestive heart
failure has increased sixty per cent. According to the American Heart
Association, approximately five million Americans are currently afflicted with
HF and 550,000 new cases are diagnosed each year. The prevalence of HF is
expected to continue increasing due to the aging population and improved
survival rates of patients with other cardiovascular diseases.

About NT-proBNP

NT-proBNP is widely recognized as a definitive marker for the diagnosis of HF.
NT-proBNP is cleaved from the precursor peptide proBNP in quantities directly
proportional to its biologically active counterpart BNP and in close
correlation with the severity of heart failure. BNP is secreted primarily from
the left ventricle in response to pressure overload and regulates blood
pressure, electrolyte balance and fluid volume. BNP acts to reduce the
pressure overload. Elevated levels of NT-proBNP indicate the presence of heart
failure, and provide physicians with an important diagnostic tool in the early
detection and management of HF. Independent published studies show that
NT-proBNP is also valuable for: risk stratification of patients with stable
coronary heart disease, as a prognostic marker across the entire spectrum of
cardiovascular diseases, potentially detecting early stages of HF in the
absence of clinically obvious symptoms, and for the assessment of prognosis
for patients with HF and for patients who have previously had a myocardial
infarction.

About Response Biomedical

Response Biomedical develops, manufactures and markets rapid on-site
diagnostic tests for use with its RAMP(R) Platform for clinical and
environmental applications. RAMP(R) represents a new paradigm in diagnostics
that provides high sensitivity and reliable information in minutes. It is
ideally suited to both point-of-care testing and laboratory use. The RAMP(R)
system consists of a Reader and single-use disposable test cartridges, and has
the potential to be adapted to more than 250 medical and non-medical tests
currently performed in laboratories. RAMP(R) clinical tests are commercially
available for the early detection of heart attack and congestive heart
failure.
In late 2006, the Company formed a strategic alliance with 3M Company to
commercialize rapid infectious disease tests and in 2008 entered into a
strategic alliance with Roche Diagnostics to commercialize cardiovascular POC
tests worldwide.
In the non-clinical market, RAMP(R) Tests are currently provided for the
environmental detection of West Nile Virus, and Biodefense applications
including the rapid on-site detection of anthrax, smallpox, ricin and
botulinum toxin. Several other product applications are under development.
Response has achieved CE Marking for its clinical products and its Quality
Management System is registered to ISO 13485: 2003 and ISO 9001: 2000.

Response Biomedical is a publicly traded company, listed on the TSX under the
trading symbol "RBM" and quoted on the OTC Bulletin Board under the symbol
"RPBIF". For further information, please visit the Company's website at
www.responsebio.com.

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SOURCE  Response Biomedical Corp.

Response Biomedical Contacts: Bill Wickson, Manager, Investor Relations,
Response Biomedical Corporation, Tel (604) 456-6073, Email:
bwickson@responsebio.com; Brian Korb, Vice President, The Trout Group LLC,
Tel: (646) 378-2923, Email: bkorb@troutgroup.com
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