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.
