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

    VANCOUVER, July 22 /CNW/ - 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

    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
    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

    Statements contained in this press release relating to future results,
events or developments, for example, statements containing the words
"believes," "may," "could", "plans," "will," "estimate," "continue,"
"anticipates," "intends," "expects", "goal" and similar expressions, are
"forward-looking statements" or "forward-looking information" under applicable
United States and Canadian securities laws. Forward-looking statements or
information may involve, but are not limited to, comments with respect to our
planned activities, business plan and strategies and their future
implementation, and our expectations for our financial condition and the
results of, or outlook for, our business operations generally. Forward-looking
statements or information are subject to the related assumptions made by us
and involve known and unknown risks, uncertainties and other factors that may
cause actual results, events or developments to be materially different from
those expressed or implied by such statements or information. Many of such
risks, uncertainties and other factors form part of our underlying
assumptions, and include, among other things, financial risks that would
affect our operations such as our available working capital and cash flows and
whether and for how long available funds will be sufficient to fund our
operations and our ability to raise additional capital as and when needed; our
need for substantial additional funding to conduct research and development
and commercialization activities; our ability to establish, and our dependence
upon, relationships with strategic alliance partners to develop and
commercialize products; technological changes that impact our existing
products or our ability to develop and commercialize our products; our ability
to obtain and enforce timely patent and other intellectual property protection
for our technology and products; liability for patent, product liability and
other claims asserted against us; commercialization limitations imposed by
patents owned or controlled by third parties; our ability to retain, and our
reliance upon, third party suppliers, manufacturers, distributors and alliance
partners; our ability to effectively and efficiently manage the planned growth
of our operations; our ability to profitably sell our products at prices that
would be acceptable to third-party reimbursement programs; competition
including competition from others with significantly more resources; market
acceptance of our products and the size of our markets; changes in business
strategy or development plans; changes in, or the failure to comply with,
governmental regulations; and other factors referenced in our annual report,
our Annual Information Form (AIF) (Form 40-F in the U.S.) and other filings
with Canadian and United States securities regulatory authorities.
    Given these uncertainties, assumptions and risks, readers are cautioned
not to place undue reliance on such forward-looking statements or information.
We disclaim any obligation to update, or to publicly announce any revisions
to, any such statements or information to reflect future results, events or
developments, except as required by law.

For further information:

For further information: Response Biomedical Contacts: Bill Wickson,
Manager, Investor Relations, Response Biomedical Corporation, Tel (604)
456-6073, Email:; Brian Korb, Vice President, The
Trout Group LLC, Tel: (646) 378-2923, Email:

Organization Profile


More on this organization

Custom Packages

Browse our custom packages or build your own to meet your unique communications needs.

Start today.

CNW Membership

Fill out a CNW membership form or contact us at 1 (877) 269-7890

Learn about CNW services

Request more information about CNW products and services or call us at 1 (877) 269-7890