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Response Biomedical Receives U.S. FDA 510(k) Market Clearance of Rapid Influenza A+B Test
Thursday April 17, 8:00 am ET
VANCOUVER, April 17 /PRNewswire-FirstCall/ - 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 Influenza A+B test (Flu A+B test) and a new version of the RAMP® Reader, the RAMP® 200.
The test manufactured by Response Biomedical runs on the new RAMP® 200 Reader and will be marketed and sold worldwide 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 with the 3M(TM) Rapid Detection Reader (manufactured by Response) to identify the presence of Flu A and Flu B nucleoprotein antigen in nasopharyngeal swab, nasopharyngeal aspirate, nasal wash/aspirate specimens. Measurement of Flu A and Flu B aids in the rapid differential diagnosis of influenza viral infections through use of this test.
"FDA clearance of our rapid Flu A+B test will allow us to take advantage of an attractive and growing market," said S. Wayne Kay, CEO, Response Biomedical. "We believe with 3M Health Care's strong marketing and distribution network, we can quickly introduce this product to the worldwide market. FDA clearance in the U.S. market is an important step toward this goal."
"The unique science and technology Response Biomedical built into this test will bring a new level of confidence to diagnosing Flu A and Flu B. We look forward to introducing this important new product to the worldwide health care market," said Chuck Kummeth, vice president and general manager, 3M Medical Division. "The 3M Rapid Detection Flu A+B Test will be the first product sold in the United States as part of our Medical Diagnostics platform. This underscores our commitment to providing a full spectrum of products that detect, prevent and control infections in the hospital setting."
3M Health Care anticipates launching prior to the 2008-09 flu season in certain markets around the world.
I didn't listen to CC.
Care to elaborate on what was positive in the CC?
I need some help to not feel pessimistic about the future of the point of care tests in the pipeline. It seems things are progressing so slowly that I wonder if the concept is flawed.
Urche
I think the CC was more positive than the press release.
Yawn. I've been expecting news on the FDA decision on the BNP test for more than 6 months. Here is another corporate update that doesn't explain the delay or give stockholders reason to do anything except continue to hibernate.
Corporate Update
"I'm very happy to have joined Response Biomedical in September 2007," said S. Wayne Kay, CEO. "It has been an extremely interesting and invigorating few months as we focused on finalizing two important submissions to the U.S. Food and Drug Administration for clearance of both our RAMP® NT-proBNP Test for diagnosis of congestive heart failure and our Rapid Influenza A+B Test (Flu A+B). We have also concentrated our energy on pursuing a worldwide marketing partner for our cardiovascular line of RAMP® rapid tests," continued Mr. Kay. "In conjunction with 3M Company, our work is ongoing to lay the groundwork for the launch of the Flu A+B Test. 3M anticipates launching prior to the 2008-09 flu season in certain markets around the world. We have also initiated feasibility work on identifying the next infectious disease tests for 3M to market."
"We see 2008 as very promising. We see a growing emphasis on preventive medicine and testing, which we believe will spur the demand for the adoption of point-of-care diagnostics for screening, for emergency applications and for monitoring the health status of the patient. As we have just moved to our new state-of-the art facility and begin the scale-up of our manufacturing capabilities to meet projected partners' demand, we believe the Company is well-positioned to capitalize on these large and growing markets."
Luminex and their Flu Test
http://www.forbes.com/markets/economy/2008/01/03/luminex-flu-test-markets-equity-cz_as_0103markets28.html
Nice gain today, look for more next week. I have a gut feeling we will see FDA approval for NtProBNP before the end of the year. I've loaded up big time the last couple weeks from .86 down to .76. Looks like it will pay off.
I talked to the company the other day and was told there is nothing wrong and that they expect approval any day now. He said the delays are with the FDA, staff turnovers etc. Its a done deal imo, just have to wait a little longer. Its better that we trade on the TSX when news hits, it will go much higher.
Last I heard they were in labelling discussions. I wonder how long that can take?
http://www.haywood.com/pdffiles/RBMNov292007.pdf
Hi Urche
I'm hoping that approval happens tomorrow. There seems to be a flurry of activity right before the holidays and then about a month delay before the next set of approvals. Not surprising but that is what historically has happened.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/mda/mda-list.cfm?list=1
seschm
TSX listing---good but worrisome PR
What is not stated is what worries me.
From the PR today:
VANCOUVER, Dec. 20 /CNW/ - Response Biomedical Corporation (TSX: RBM, OTCBB: RPBIF) today announced that its common shares have been approved for listing on the Toronto Stock Exchange (TSX) and will no longer trade on the TSX Venture Exchange. Trading on the TSX will commence tomorrow, Friday, December 21, 2007 under the symbol "RBM". Response Biomedical Corporation was initially listed and began trading on the TSX Venture Exchange on April 9, 1984.
"Our listing on the TSX provides access to a broader base of potential investors and supports our strategic growth objectives," said S. Wayne Kay, CEO. "We believe our most significant near-term business milestone is the anticipated signing of a global marketing partner for our cardiovascular line of RAMP(R) rapid tests. Finding the right strategic partner in the cardiovascular area has been my primary focus since joining the Company and we are in active discussions to have this completed as soon as reasonably possible."
The fact that the partnership is the next milestone on the horizon gives me a sense of foreboding that the long awaited approval for the Response NT pro-BNP test is still mired in FDA delays. The company has been strangely, publicly quiet about the delay in approval. I learned that they have amended the filing in ways that would give the test some marketing advantages. But, still, I don''t like the indefinite delay and lack of news--gives me a sense of foreboding.
urche
RBM starts trading on Toronto TSX exchange Friday December 21 at open.
Response Biomedical to list on TSX on Dec. 21
2007-12-19 20:32 ET - New Listing
TSX bulletin 2007-1799
An application has been granted for the original listing in the industrial category of 155,067,877 common shares of the company, of which 129,977,631 common shares are issued and outstanding, and 25,090,246 common shares are reserved for issuance.
The common shares of the company will be listed and posted for trading at the open on Friday, Dec. 21, 2007.
The company is subject to the reporting requirements of Section 501 of the Toronto Stock Exchange company manual.
Common share symbol: RBM
Common share Cusip No.: 76123L 10 5
Common share trading currency: Canadian dollars
Designated market-maker: Dundee Securities Corp.
Thanks for posting the update.
Updated Haywood Report out Nov 29
http://www.haywood.com/pdffiles/RBMNov292007.pdf
Good to see that they are finalizing labeling of the Nt-Pro BNP with the FDA. Approval should be soon.
I listened, very impressive. The only thing that bothered me was his statement about the last financing being in the money. There may be some profit taking from this little spurt. Of course we could get approval for NtProBNP anyday.
yes, nicely done and highlighted the performance advantages of RAMP over the both POC and central lab tests. Partner for NT-ProBNP within the next month or two. Manufacturing scaleup underway to go from the current 1 Million cartridges per year(now) to 4 million by early 2008 and and then by 2008/09 10 million per year and 15 million per year in 2010.
Still expect Flu test approval with next few months but 3M won't push it for this flu season as it will be too late.
The Stockhouse board seems to be a good source for information. I have not been to the Silicon site. The Investor Village and Raging Bull CAMH boards have a lot of people who are invested in RBM (RPBIF). Looking forward to some good news and an informative update on Tuesday.
I talked to IR last week, we are ever so close to FDA approval and a partnership on ProBNP. I hope they come Monday before the conference. I didn't know there was a board for RBM on I-Hub, I've been in this stock since 1996. There's a stockhouse board that is pretty good, and also one on Silicon Investor. We'll probably double from here real easy.
Webcast
http://www.stockhouse.ca/bullboards/viewmessage.asp?no=16657716&t=0&all=0&TableID=0
Rodman & Renshaw 9th Annual Healthcare Conference
Presenter: S. Wayne Kay, CEO
9:10 a.m. to 9:30 a.m.
Tuesday November 6, 2007
Kennedy Room 1 - 4th Floor
The New York Palace Hotel
New York, NY
Listen to the Webcast. Link on website
http://www.responsebio.com/newsroom_events_calendar_corporate.asp?menu=1&submenu=4
thanks for sharing.
FYI Updated Haywood Report
http://www.haywood.com/pdffiles/RBMOct252007.pdf
No staph question.
I was more interested in pro-BNP which will not be marketed by 3M. Staph seems to be in the headlines these days, however, so maybe we'll see some collateral benefit.
Did you inqure about the status of the Staph test?
Thanks
Thanks Urche (EOM)
urche, appreciate your post. Time is on our side. glty
Response in November?
Admittedly impatient to learn about the FDA's decision re NT-pro BNP, I recently called the company for info. It turns out that there indeed have been some amendments and delays to the application. But it may be a good thing in the long run. In august Response submitted additional info which may substantiate the claim that the pro-BNP test is in some ways SUPERIOR rather than equivalent to existing tests. That would be a big deal, IMO, and worth the additional wait. So, the 90 day clock restarted ticking in Aug. But a decision is not necessarily expected by Nov. because the 90 day figure is just a guideline, not an FDA mandate. I expect the next few months to be more than interesting for Response. The 3M flu test may get approval during this flu season (early 2008?) as well.
Patiently,
Urche
Clinical and Analytical Sensitivity of a Rapid Detection Flu A+B Assay: Presented at IDSA
By Kristina R. Anderson
SAN DIEGO, CA -- October 10, 2007 -- A new rapid 15-minute influenza diagnostic assay test -- the 3M(TM) Rapid Detection Flu A+B Test -- is at least as sensitive as the currently available test for influenza virus A+B, according to research findings presented here at the Infectious Diseases Society of America (IDSA) 45th Annual Meeting.
Lead author Suzanne E. Dale, PhD, Assistant Professor, Department of Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario, Canada, discussed the study in an oral presentation on October 5. The research was conducted while she was Clinical Microbiology Fellow, University of Rochester Medical Center, Rochester, New York.
Dr. Dale and colleagues analyzed 249 clinical specimens submitted for routine respiratory virus culture between January and March 2007. They instituted a start/stop protocol to ensure they had enough positive specimens. They then compared the 3M Rapid Detection Flu A+B Test to culture in primary Rhesus monkey kidney cells and other tests currently on the market.
Findings from this study were originally presented to the US Food and Drug Administration (FDA) as part of the submission for approval. They included the following:
· For influenza A the 3M Rapid Detection Flu A+B Test was clinically more sensitive than the BinaxNOW(R) Influenza A&B test and equally sensitive to the Quidel QuickVue(R) Influenza A+B test;
· For influenza A, the 3M test was analytically more sensitive than the BinaxNOW and BDTM Influenza tests and equally sensitive to the Quidel QuickVue Influenza A+B test;
· For influenza B the 3M test was analytically more sensitive than the BinaxNOW, BD Directigen™ Influenza Test Kits and Quidel QuickVue(R) influenza tests.
The 3M rapid test is a lateral-flow immunochromatographic assay that detects the nucleoprotein of the influenza virus and is used with an automated reader for the detection and differentiation of influenza A and B. It is useful for nasal swabs and washes and nasopharyngeal swabs and aspirates. Also, results are achieved in about 15 minutes.
"The 3M test for influenza provides point-of-care testing and gives physicians a mechanism for facilitating their clinical decision making. It also reduces time spent ordering tests and eliminates specimen transport and handling," Dr. Dale said.
Rapid influenza testing leads to reductions of antibiotic use in hospitalized adult populations and is important for infection control with the commencement of an antiviral therapy.(1)
By differentiating between A and B, the 3M test will help physicians in selecting an appropriate therapy. Another advantage of this new test is that a patient's treatment can be initiated quickly, thus reducing transmission.
The 3M test is currently undergoing drug application review with the FDA. The product will be priced competitively with other similar tests on the market, according to a 3M spokesperson.
Dr. Dale said: "Our study is very important in that it shows the 3M test is, at a minimum, the same or equivalent to the other tests on the market. This new 3M test may be another option in the diagnostic influenza market."
Funding for this study was provided by 3M and Response Biomedical.
we are all wondering about the NT pro BNP test approval from the FDA. I went through some of the PMA approval letters from the CDHR section of the FDA. For each of the approval letters I looked at they had many amendments and approval could come several months after the last one or sometimes just a few days later.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/mda/mda-list.cfm?list=1
Rad had announced that he would be stepping down about 6 months ago but would remain CEO until they found a replacment. I haven't heard anything about p-BNP except what we all read in their press releases saying that they have filed their application and are waiting for a response.
CEO announcement
Jeezum I feel out of the loop. I was not aware that Radvak had resigned (if that is what happened).
But this looks like a very strong move on the part of Response, to hire a CEO who was a honcho at Quidel, a company I keep on my radar as one of Response's closest and much larger competitors.
I am still surprised at how long the FDA is taking to make its pro-BNP decision.
Anyone have an idea what to expect over the next few months?
urche
Press Release Source: Response Biomedical Corp.
Response Biomedical appoints S. Wayne Kay Chief Executive Officer
Wednesday September 12, 8:30 am ET
VANCOUVER, Sept. 12 /CNW/ - Response Biomedical Corporation (TSX-V: RBM, OTCBB: RPBIF) today announced the appointment of S. Wayne Kay as Chief Executive Officer (CEO). Mr. Kay was also appointed to the Company's Board of Directors.
Mr. Kay is a former President, CEO and Director of Quidel Corporation, a leading global company in the discovery, development, manufacturing and marketing of rapid diagnostic solutions at the point-of-care (POC) in infectious diseases and reproductive health. During his tenure he designed and managed a strategy responsible for building and sustaining unprecedented market leadership of rapid influenza testing (from an approximately 2 percent to 49 percent market share). He was also responsible for significantly improving the financial performance of the company during his tenure. Since leaving Quidel in 2004, Mr. Kay served as an executive advisor to the management and boards of several early stage companies, mainly in the San Francisco and San Diego areas. He also served as an executive advisor to one of the US's most successful blue-chip healthcare/life sciences venture capital funds, Kleiner Perkins Caufield and Byers.
"We are very excited to have attracted such an experienced, proven executive to lead Response Biomedical," said Dr. Richard Bastiani, Chairman. "Wayne has a wealth of experience in the diagnostics industry, and particularly in POC, and has a proven acumen for building strong teams and executing on strategy. He led Quidel through a strong expansion phase in their history and his many years experience will be invaluable to lead the Company, as we begin our expected rapid growth phase."
"I am very pleased to be joining Response Biomedical at this exciting time in the evolution of the Company," said Mr. Kay. "With partnerships in place with Shionogi & Co. Ltd. and 3M Company, we are poised for strong growth. I look forward to leading the execution of our cardiovascular partnering strategy, as well as the scale-up in manufacturing, the launch of the new RAMP(R) Reader and the regulatory approval of three products, all anticipated in the next few quarters. These are the building blocks which I believe will significantly enhance shareholder value."
Dr. Bastiani continued, "On behalf of the Board of Directors, I'd also like to take this opportunity to thank Bill Radvak for his many years of dedicated service to the Company."
As part of Mr. Kay's compensation package, he has been granted options to acquire 1,500,000 common shares of the Company, subject to vesting requirements. The options are exercisable at a price of $1.07 per common share.
About Response Biomedical
I thought this was interesting. I guess they aren't segmenting the public from the early builds on the 3M website.
http://tinyurl.com/2d4rnl
rest of abstract
For some reason I couldn't get the entire abstract to post. sorry about that. If anyone wants the abstract or article, send me a private email.
urche
Article in major journal
Recent activity may be partly fueled by late June publication of the IMPROVE-CHF study. I don't think this is new news, but acceptance by academics and clinicians is always helped by publication of result in a reputable journal. The article cites Roche as sponsor. There is an accompanying editorial generally positive about the importance of the test, at least for its potential to contribute cost-effectively to decision making within the Canadian health care system. Applicability to the US and comparison to the more commonly used BNP tests in US remain open and relevant questions.
Here is the abstract from Circulation, Journal of American Heart Association:
N-Terminal Pro–B-Type Natriuretic Peptide Testing
Improves the Management of Patients With Suspected Acute
Heart Failure
Primary Results of the Canadian Prospective Randomized Multicenter
IMPROVE-CHF Study
Gordon W. Moe, MD; Jonathan Howlett, MD; James L. Januzzi, MD; Hanna Zowall, MA; for the
Canadian Multicenter Improved Management of Patients With Congestive Heart Failure
(IMPROVE-CHF) Study Investigators
Background—The diagnostic utility of N-terminal pro-B-type natriuretic peptide (NT-proBNP) in heart failure has been
documented. However, most of the data were derived from countries with high healthcare resource use, and randomized
evidence for utility of NT-proBNP was lacking.
Methods and Results—We tested the hypothesis that NT-proBNP testing improves the management of patients presenting
with dyspnea to emergency departments in Canada by prospectively comparing the clinical and economic impact of a
randomized management strategy either guided by NT-proBNP results or without knowledge of NT-proBNP
concentrations. Five hundred patients presenting with dyspnea to 7 emergency departments were studied. The median
NT-proBNP level among the 230 subjects with a final diagnosis of heart failure was 3697 compared with 212 pg/mL
in those without heart failure (P
Double average volume in 2 1/2 hours. Looks like news coming. What are possible revenues here with approval?
Big volume in Canada today
http://finance.yahoo.com/q?s=RBM.V
news
That's not the news I was hoping for!
There was some interesting trading at end of day.
Looks like some speculators were fooled into a losing bet when the trading halt was announced.
Right after the trading halt was announced on TSX around 3:30 pm, the shares of RPBIF skyrocketed more than 20% in US.
http://finance.yahoo.com/q/bc?s=RPBIF.OB&t=1d&l=on&z=m&q=l&c=
I was hoping this would be news that FDA has approved Response's BNP test. If that news is coming soon, those shares bought for $1 today will look like a sweetheart deal. OTOH, if FDA approval is not forthcoming, the company will look smart for having raised $12M while conditions were good.
Urche
Response Biomedical Announces $12 Million Bought Deal Private Placement
/NOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES OR FOR DISSEMINATION IN
THE UNITED STATES/
VANCOUVER, July 9 /CNW/ - Response Biomedical Corporation (TSX-V: RBM,
OTCBB: RPBIF) today announced that the Company has entered into an agreement
with Haywood Securities Inc. pursuant to which the Company has agreed to issue
and sell, by way of a bought deal private placement, an aggregate of
12,000,000 common shares of the Company at a price of $1.00 for each common
share.
Haywood Securities Inc. will be paid a commission of seven percent of the
gross proceeds, paid in cash on the closing date in connection with the
financing. The securities issued under the private placement will have a hold
period under Canadian law, National Instrument 45-102, of four months from the
closing.
This private placement financing is subject to the receipt of all
necessary regulatory approvals, including the approval of TSX Venture
Exchange. This offering is not available to US investors.
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
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
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.
2nd shift manager job opening at RPBIF
http://www.responsebio.com/careers_job_description.asp?menu=1&height=1100&position=careers_p...
This article is Titled "Impact of Rapid Diagnosis on Managment of Adults Hospitalized with Influenza"... Feb 2007
http://archinte.ama-assn.org/cgi/content/full/167.4.ioi60207
Response Bio gets approval to market NT-proBNP test in Canada. I'm assuming the U.S. decision will be out any day, as 180 days will be June 14th.
http://biz.yahoo.com/prnews/070612/to367.html?.v=20
Press Release Source: Response Biomedical Corp.
Response Biomedical Receives Approval to Market NT-proBNP Congestive Heart Failure Marker Test in Canada
Tuesday June 12, 8:30 am ET
VANCOUVER, June 12 /PRNewswire-FirstCall/ - Response Biomedical Corporation (TSX-V: RBM, OTCBB: RPBIF) today announced that it has been granted a medical device license by Health Canada to market its RAMPO NT-proBNP Test. Measurement of NT-proBNP aids in the diagnosis and assessment of severity in individuals suspected of having congestive heart failure (CHF) and may aid in the risk stratification of patients with acute coronary syndrome and heart failure. This allows the Company to market, in Canada, diagnostic tests for a full line of cardiac markers for acute myocardial infarction (AMI) and congestive heart failure (CHF). The Company currently markets the product in Europe and has applied for FDA clearance of the test in the United States.
"We are very pleased to receive country of origin approval to market the NT-proBNP test in Canada," said Bill Radvak, President and CEO. "We have been able to offer a comprehensive line of AMI diagnostics, including Troponin I, CK-MB and Myoglobin, and the addition of NT-proBNP for CHF should heighten interest in our cardiovascular product line."
About CHF
CHF impedes the ability of the heart to pump blood at a rate sufficient to support the body's vital needs. CHF affects nearly 17 million people worldwide, and is the single most frequent cause of hospitalization in people over 65 years. The initial diagnosis of CHF 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 Stoke 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 CHF and 550,000 new cases are diagnosed each year. The prevalence of CHF 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 CHF. 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 CHF. 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 CHF in the absence of clinically obvious symptoms, and for the assessment of prognosis for patients with CHF and for patients who have previously had a myocardial infarction (references available upon request).
Yep....we done good. Looking forward !! glty
Earnings were announced today
http://micro.newswire.ca/release.cgi?rkey=1505306949&view=31910-0&Start=0
I haven't had time to go through it yet, but it was obviously pleasing.
Best regards,
Geoff
OT: Urche, CAMH has one major binary event, due in November: Release of MASTER I and II data. This would be the last "major study" that some holdout cardiologists are waiting for.
Take care,
Geoff
You may already know this but if you use rbm.v in yahoo you can see its also up 10% on the vancover exchange on very heavy volume. Don't know why either.
Any idea what's up?
RPBIF is up 10% today. Some of the recent strength is attribuable to the loonie /US$ exchange rate, but Response is my only green ticker today. Any idea what's going on?
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Response Biomedical Corporation
1781 - 75th Avenue W.
Vancouver, BC
V6P 6P2 CANADA
About Response Biomedical
Response Biomedical develops, manufactures and markets rapid on-site diagnostic tests for use with its 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 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, congestive heart failure, influenza and RSV through our commercial partners, Roche and 3M Health Care respectively.
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.
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.
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.
"I am very pleased to be leading Response Biomedical at this exciting time in the evolution of the Company. With partnerships in place with 3M Company, Roche Diagnostics and Shionogi & Co. Ltd., we are poised for strong growth. We also announced a new collaboration to develop a diagnostic for TB. We have begun working with FIND, a Bill and Melinda Gates-funded organization and we are excited about this and other future opportunities we continue to explore.
We are fortunate to be housed in a state-of-the-art manufacturing and product development facility. This global Headquarters will allow us to scale-up manufacturing to meet the needs of our current and future business partners and customers.
We have begun to see our major clinical tests launched into the marketplace by our partners. 3M launched the Flu A+B Test in October 2008 and Roche Diagnostics, the largest in vitro diagnostics company in the world, has now launched the cardiovascular line of products.
These are the building blocks which I believe will significantly enhance shareholder value while recognizing the extraordinary accomplishments of our Response Biomedical Team as a leader in the rapid point-of-care diagnostics marketplace."
S. Wayne Kay, CEO
VANCOUVER, British Columbia--(BUSINESS WIRE)--Response Biomedical Corporation (TSX: RBM, OTCBB: RPBIF) announced that the Company has been granted a Special 510(k) U.S. FDA clearance for an update to the Company’s RAMP® Influenza A/B Assay Package Insert to include analytical reactivity information for a strain of the 2009 H1N1 virus cultured from positive respiratory specimens. The RAMP® Influenza A/B Assay is marketed in the United States by 3M Health Care as the 3M™ Rapid Detection Flu A+B Test and is used to identify influenza A and B in human specimens.
Although the RAMP® Influenza A/B Assay has been shown to detect the 2009 influenza A (H1N1) virus in cultured isolates, the performance characteristics of this device with clinical specimens that are positive for the 2009 influenza A (H1N1) virus have not been established. The RAMP® Influenza A/B Assay can distinguish between influenza A and B viruses, but it cannot differentiate influenza subtypes.
“We are very cognizant of physicians’ needs to quickly diagnose influenza and improve patient care in light of a potential influenza pandemic,” said S. Wayne Kay, Chief Executive Officer. “This clearance further validates our technology and combined with our recent RSV clearance will give 3M additional tools to promote the 3M™ Rapid Detection platform to hospitals, which help play a critical role in diagnosing and containing any upper respiratory infection outbreak.”
Clinical Products Revenues Grow 373% over Q2 2008
VANCOUVER, British Columbia--(BUSINESS WIRE)--Response Biomedical Corporation (TSX:RBM) (OTCBB:RPBIF) reported that clinical products revenue for the three and six month periods ended June 30, 2009 increased 373% and 208% to $1,805,308 and $3,548,014, respectively, compared to $381,615 and $1,150,760 for the same periods in 2008. Total revenues for the second quarter increased 174% from the same quarter in 2008, from $997,515 in Q2/2008 to $2,735,415 in Q2/2009.
For the three and six month periods ended June 30, 2009, the Company reported a loss of $1,898,987 or $0.01 per share and $3,630,402 or $0.02 per share, respectively, compared to a loss of $3,740,494 or $0.03 per share and $7,284,605 or $0.05 per share for the same periods in 2008. This decrease in the loss for the three and six months period ended June 30, 2009 of 49% and 50%, respectively, is primarily due to higher gross profit on product sales, higher contract service fee and revenues from collaborative research arrangements and reduced expenses across all departments.
“We are continuing to show strong results as we work with our partners to introduce our rapid point-of-care (POC) diagnostic tests to an expanding market,” said S. Wayne Kay, CEO, Response Biomedical. “We had the second consecutive quarter with the highest revenues for any quarter in the Company’s history. These strong financial results for the first half of 2009 ensure we remain on track to finish the year with record revenues.”
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Title : Response Biomedical Q3 Update
Date : Tuesday November 10th, 2009 at 10:00 AM ET
Event Details:
Response Biomedical Corp. engages in the research, development, commercialization, and distribution of diagnostic technologies for the medical point-of-care (POC) and on-site environmental testing markets. It provides a technology called Rapid Analyte Measurement Platform (RAMP), which is a portable fluorescence immunoassay-based diagnostic technology that combines the performance of a clinical lab with the convenience of a dipstick test. The company's RAMP tests are used in the early detection of heart attack, congestive heart failure, environmental detection of West Nile Virus, and biodefence applications, including the rapid onsite detection of anthrax, smallpox, ricin, and botulinum toxin.
Response Biomedical also develops and manufactures RAMP immunoassays for clinical, pharmaceutical, industrial, environmental, and agricultural applications. It has operations in Canada, the United States, and Asia. The company was founded in 1980 and is based in Burnaby, Canada.
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