SI
SI
discoversearch

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor.  We ask that you disable ad blocking while on Silicon Investor in the best interests of our community.  If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.
Gold/Mining/Energy : Response Biomedical (V.RBM) -- Ignore unavailable to you. Want to Upgrade?


To: Starowl who wrote (503)5/25/2004 9:10:46 AM
From: Starowl  Read Replies (1) | Respond to of 655
 
Another FDA clearance. Two in a week. Starting to roll.

"Response Biomedical Receives US FDA Clearance For Third RAMP(R) Cardiac Marker Test
Tuesday May 25, 9:00 am ET

The Company Receives Final Clearance To Launch Its Lead Clinical Product Line To Assist In The Rapid Detection Of Heart Attacks
VANCOUVER, May 25 /CNW/ - Response Biomedical Corp. (TSX-V: RBM - News), today announced that it has received regulatory clearance from the US Food and Drug Administration (FDA) to market its RAMP Cardiac Marker Test for detecting CK-MB to assist in the rapid diagnosis of heart attack or acute myocardial infarction (AMI). Last week, the Company received FDA clearance of its high sensitivity RAMP test for detecting troponin I, broadly recognized as the cardiac marker of choice allowing increased sensitivity and specificity in diagnosing AMI. The Company has now received FDA 510(k) regulatory clearance for its fluorescence-based RAMP Reader for general clinical use, and three RAMP Cardiac Marker Tests for detecting myoglobin, troponin I and CK-MB.
"FDA clearance to commercially introduce the lead RAMP clinical product line into the US medical market will enable the Company to aggressively expand its international marketing and distribution network over the coming months," states Bill Radvak, President and CEO. "Based on the performance during multi- center US clinical trials, the Company is confident the RAMP Cardiac Marker Tests will receive strong market adoption, as we pursue further clinical applications in stroke, oncology and infectious disease testing."