VANCOUVER, June 11 /CNW/ - Response Biomedical Corporation (TSX-V: RBM,
OTCBB: RPBIF) announced today that it has filed a US Food and Drug
Administration (FDA) 510(k) submission seeking clearance to market a rapid
Influenza A+B test.
The test manufactured by Response will run on the RAMP(R) platform and
will be marketed and sold exclusively by 3M Health Care as the 3M(TM) Rapid
Detection Flu A+B Test. It is a qualitative immunochromatographic assay
indicated for use as an in vitro diagnostic product used with the 3M(TM) Rapid
Detection Reader (manufactured by Response) to identify the presence of
Influenza A and Influenza B (Flu A and Flu B) nucleoprotein antigen in nasal
wash, nasal swab, nasopharyngeal aspirate and nasopharyngeal swab specimens.
Measurement of Influenza A and Influenza B aids in the rapid differential
diagnosis of influenza viral infections through this point-of-care (POC) test.
POC or "near-patient" testing allows for diagnostic assays to be
performed at the site of patient care delivery. POC testing provides for rapid
clinical decision-making by reducing the time spent ordering tests, collecting
and transporting samples, as well as retrieving data.
"Once again, RAMP has demonstrated exceptional performance," said Bill
Radvak, President and CEO. "Attendance at several recent trade shows has seen
lots of excitement about the RAMP Reader's ability to not only give a positive
indication of flu but also delineate between Flu A and B. This is seen by many
as being superior to our competitors' manual strips." Both companies hope to
make this important test commercially available before the next U.S. flu
Flu is a contagious disease caused by the influenza virus. Influenza
viruses are classified into types A, B and C. Type A is a reportable disease,
and is the most common and usually causes the most serious epidemics. Type B
outbreaks also can cause epidemics, but the disease it produces is generally
milder than that caused by type A. Type C viruses have never been connected
with a large epidemic. Flu A is most prevalent and causes 87 percent of
infections with the remaining 13 percent of reported cases being Flu B.
Every year, 5 percent to 20 percent of the U.S. population suffers from
flu. Approximately 36,000 people infected with the flu die each year, and over
200,000 are admitted to hospital. During an average flu season, flu and flu
related complications are the sixth leading cause of death in the United
Although most people who get the flu recover within a week, some of the
medical complications caused by flu infection include bacterial pneumonia,
dehydration and worsening of chronic medical conditions, such as congestive
heart failure, asthma or diabetes. Children may develop sinus problems and ear
infections as complications from flu infections. It is these complications,
rather than the symptoms of flu themselves that lead to serious concerns with
rapid diagnosis of infected individuals. The Centers for Disease Control (CDC)
recommend that any person at high risk for serious complications of influenza
and who is within the first two days of illness onset should be treated with
About Response Biomedical
Response Biomedical develops, manufactures and markets rapid on-site
diagnostic tests for use with its portable RAMP Platform for clinical and
environmental applications. RAMP 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 system
consists of a portable fluorescent 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 clinical tests are
commercially available for the early detection of heart attack and congestive
In late 2006, the Company formed a strategic alliance with 3M Company to
commercialize rapid infectious disease tests.
In the non-clinical market, RAMP 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. The
Company 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
Venture Exchange 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.
About 3M Health Care
Since inventing Ioban(TM) antimicrobial incise surgical drapes more than
30 years ago, 3M has been a worldwide leader in developing health care
products and services that address infection control. 3M Health Care, one of
3M's six major business segments, is dedicated to improving the practice,
delivery and outcome of patient care and is a leading provider of solutions
for medical, oral care, drug delivery and health information markets.
Ioban is a trademark of 3M.
The TSX Venture Exchange has not reviewed and does not accept
responsibility for the adequacy or accuracy of this release.
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, 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; our ability to obtain and maintain rights to
technology from licensors; commercialization limitations imposed by patents
owned or controlled by third parties; our ability to retain, and our reliance
upon, third party suppliers, manufacturers and distributors; 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; 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 on Form 20-F 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
For further information:
For further information: Response Biomedical Contacts: Bill Wickson,
Manager, Investor Relations, Response Biomedical Corporation, Tel (604)
456-6073, Email: firstname.lastname@example.org; Brian Korb, Vice President, The
Trout Group LLC, Tel: (646) 378-2923, Email: email@example.com