Virtually All Children Infected by the Age of Two(1)
VANCOUVER, April 28 /CNW/ - Response Biomedical Corporation (TSX: RBM,
OTCBB: RPBIF) announced today that it has filed a U.S. Food and Drug
Administration (FDA) 510(k) submission seeking clearance to market its
Respiratory Syncytial Virus (RSV) test.
The test, manufactured by Response Biomedical, will run on the RAMP(R)
diagnostic platform and will be marketed and sold exclusively by 3M Health
Care as the 3M(TM) Rapid Detection RSV Test. It is a qualitative
immunochromatographic assay indicated for use as an in vitro diagnostic
product to identify the presence of the RSV antigen. Rapid detection of RSV
aids hospital laboratories and physician office laboratories in the rapid
diagnosis of RSV.
"We believe we have a strong submission for review by the FDA," said S.
Wayne Kay, Chief Executive Officer, Response Biomedical. "There remains a
significant clinical need for a rapid test that provides high clinical
sensitivity for RSV compared to viral culture or DSFA. This submission is
another step forward in building our business through the commercial launch of
products through strong partnerships."
FDA 510(k) clearance would give physicians access to a test that quickly
diagnoses the presence or absence of the RSV virus and may help optimize the
clinical management of the RSV-positive patient. The RAMP diagnostic platform
brings objectivity to the interpretation of RSV tests using an automated
Reader. Automating and storing the qualitative RSV test result may help
increase laboratory productivity and minimize the potential for human error,
which can contribute to improved patient outcomes. In the United States, RSV
is responsible for thousands of hospitalizations annually among children
younger than one year. It is believed to be the most common viral cause of
death in children younger than five years and in particular in children
younger than one year. In the first two years of life, virtually all children
are infected with the virus at some point.
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, congestive
heart failure and influenza.
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 Reader and clinical tests and its
Quality Management System is registered to ISO 13485: 2003 and ISO 9001: 2000.
The RAMP(R) Influenza A/B Assay and RAMP 200 reader are not yet licensed for
clinical use in Canada.
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
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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
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and involve known and unknown risks, uncertainties and other factors that may
cause actual results, events or developments to be materially different from
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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 limited 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; current financial market
conditions which may negatively affect our ability to obtain financing; our
ability to meet the continued listing requirements of the TSX under its
ongoing delisting review; changing facility costs and other risks relating to
our facilities expansion plans; 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; our ability to obtain and maintain rights to
technology from licensors; liability for patent, product liability and other
claims asserted against us; commercialization limitations imposed by patents
owned or controlled by third parties; technical risk in research and
development; adverse results or unexpected delays in product development and
clinical trials; our ability to retain, and our reliance upon, third party
suppliers, manufacturers, distributors and alliance partners; our ability to
attract and retain qualified personnel; our ability to effectively and
efficiently manage the planned growth of our operations; our ability to
obtain, and the timing of, necessary regulatory approvals; 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; fluctuations in
interest rates and foreign exchange rates; seasonality including government
budget cycles; general economic and business conditions where we operate; and
other factors referenced in our annual report, our Annual Information Form
(AIF) (Form 20-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,
Director, Investor Relations, Response Biomedical Corporation, Tel (604)
456-6073, Email: email@example.com