Response Biomedical Corp. (fka RPBIF)

[lumpy9200]

RPBIF applied for the 510(k) with the FDA on December 14th (see article below). I'm not certain, but I believe the FDA either usually -or always- makes a decision on 510(k) submissions within 90 days. That would make March 14th the date. The device is approved and selling in Europe. I see no reason the FDA says no here. The market for this test is immense. RPBIF has tremendous potential upside, IMO.

Best,
Geoff

http://biz.yahoo.com/prnews/061214/to487.html?.v=8

Response Biomedical Files for US FDA 510k Market Clearance of RAMP NT-proBNP Test for the Diagnosis of Congestive Heart Failure
Thursday December 14, 8:30 am ET


VANCOUVER, Dec. 14 /PRNewswire-FirstCall/ - 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 its RAMP® NT-proBNP Test for the diagnosis of congestive heart failure. The Company has also completed a European CE Declaration to market the product in Europe.
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NT-proBNP (B-type natriuretic peptide) is a biomarker used widely as an aid in the diagnosis of congestive heart failure and has also been established as a marker for prognosis in Acute Coronary Syndrome (ACS). The regulatory submission follows positive results from the recently completed multi-centre clinical trial of the RAMP NT-proBNP Test, developed under license from Roche Diagnostics GMbH. Trials began in August of this year at four US sites, the Mayo Clinic, Minneapolis Medical Research Foundation at Hennepin County Medical Center, Massachusetts General Hospital and San Francisco General Hospital.

"This clinical trial once again demonstrated the exceptional performance of our RAMP point-of-care testing platform," said Bill Radvak, President and CEO. "Our RAMP NT-proBNP Test showed strong correlation to one of the "gold standard" tests, the Roche Elecsys NT-proBNP Test which is run in a hospital central laboratory. Our RAMP platform combines the accuracy one expects from a central lab system with the speed and convenience of point-of-care testing."

"The market introduction of this test is important to Response because it is a critical addition to the menu of tests we have developed in the cardiovascular space," Radvak added. "Diagnosing and monitoring congestive heart failure using NT-proBNP has become a very important tool for physicians and consequently the market for these tests has been growing rapidly."

Roche Diagnostics recently reported that new data presented at the 2006 American Heart Association's (AHA) Scientific Sessions showed that the introduction of a NT-proBNP test could generate yearly savings up to US $600 million in the US Healthcare system. The test significantly shortened the emergency room visits by helping doctors to decide which patients with shortness of breath had heart failure and which had other conditions. Studies indicate that heart failure affects around five million Americans.

In a study conducted at Massachusetts General Hospital, and published in the American Journal of Cardiology September 2006, NT-proBNP testing was associated with a 9.4 percent reduction in costs, translating into savings of US $474 per patient per visit. More than 90 percent of these savings were attributed to prevented or reduced hospitalization (Am J Cardiol 2006; 98(6):800-805; Cost-Effectiveness of Using N-Terminal Pro-Brain Natriuretic Peptide to Guide the Diagnostic Assessment and Management of Dyspneic Patients in the Emergency Department; U. Siebert, J.L. Januzzi, M.T. Beinfeld, R. Cameron, G.S. Gazelle).

RAMP Cardiac Tests are currently commercially available throughout the US through three exclusive regional distributors, Cardio Medical Products Inc., Kentec Medical Inc and LXU Healthcare. These specialty distributors have expertise and a strong focus in the cardiac/emergency department. The addition of the RAMP NT-proBNP Test is expected to increase the potential market for the Company's RAMP cardiovascular test products to approximately $800 million worldwide.

The clinical results will be submitted for peer-review and publication in an industry journal over the coming weeks.