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Message: Rapid Respiratory Syncytial Virus Test

Rapid Respiratory Syncytial Virus Test

posted on Apr 28, 2009 07:31AM
Although there seems to be a lot excitement over the flu test this is also more grist for the mill.  Another
 piece towards building this business out.
~~dimar

VANCOUVER, April 28 /CNW/ - Response Biomedical Corporation (TSX: RBM,
OTCBB: RPBIF) announced today that it has filed a U.S. Food and Drug
Administration (FDA) 510(k) submission seeking clearance to market its
Respiratory Syncytial Virus (RSV) test.
The test, manufactured by Response Biomedical, will run on the RAMP(R)
diagnostic platform and will be marketed and sold exclusively 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 to identify the presence of the RSV antigen. Rapid detection of RSV
aids hospital laboratories and physician office laboratories in the rapid
diagnosis of RSV.
"We believe we have a strong submission for review by the FDA," said S.
Wayne Kay, Chief Executive Officer, Response Biomedical. "There remains a
significant clinical need for a rapid test that provides high clinical
sensitivity for RSV compared to viral culture or DSFA. This submission is
another step forward in building our business through the commercial launch of
products through strong partnerships."
FDA 510(k) clearance would give physicians access to a test that quickly
diagnoses the presence or absence of the RSV virus and may help optimize the
clinical management of the RSV-positive patient. The RAMP diagnostic platform
brings objectivity to the interpretation of RSV tests using an automated
Reader. Automating and storing the qualitative RSV test result may help
increase laboratory productivity and minimize the potential for human error,
which can contribute to improved patient outcomes. In the United States, RSV
is responsible for thousands of hospitalizations annually among children
younger than one year. It is believed to be the most common viral cause of
death in children younger than five years and in particular in children
younger than one year. In the first two years of life, virtually all children
are infected with the virus at some point.

(1) http://www.cdc.gov/rsv/about/infection.html
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