VANCOUVER, July 29 /CNW/ - Response Biomedical Corporation (TSX: RBM,
OTCBB: RPBIF) announced today that it received a U.S. Food and Drug
Administration (FDA) 510(k) clearance to market a rapid Respiratory Syncytial
Virus (RSV) test.
The test manufactured by Response Biomedical runs on the RAMP(R) 200
Reader and will be marketed and sold 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 with the 3M(TM) Rapid Detection
Reader (manufactured by Response) to detect the presence of RSV F-protein
antigens in nasopharyngeal swab, nasopharyngeal aspirate, or nasal
wash/aspirate specimens. Measurement of RSV aids in the rapid diagnosis of RSV
viral infections in symptomatic patients.
"FDA clearance of our rapid RSV test adds another product to the 3M
arsenal that addresses the growing need for detecting upper respiratory
infections," said S. Wayne Kay, CEO of Response Biomedical. "3M Health Care is
expected to introduce this product in the upcoming RSV season, which closely
mirrors the influenza season. 3M Health Care currently markets the 3M(TM)
Rapid Detection Flu A+B Test in the U.S. and is exploring other market
expansion opportunities. Having an additional test, which runs on the 3M(TM)
Rapid Detection Reader, should heighten market interest in these innovative
products and, once again, demonstrates the potential of Response Biomedical's
platform technology."
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. 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 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.
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 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
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;
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: Bill Wickson, Director, Investor Relations,
Response Biomedical Corporation, Tel (604) 456-6073, Email:
bwickson@responsebio.com
