Response Biomedical Files for FDA 510(k) Market Clearance of its Rapid Respiratory Syncytial Virus Test
VANCOUVER, April 28 /PRNewswire-FirstCall/ - 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® 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
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 and influenza.
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. The RAMP® Influenza A/B Assay and RAMP 200 reader are not yet licensed for clinical use in Canada.
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.
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