Response Biomedical Corporation Announces Initiation of Respiratory Syncytial Virus Infection Clinical Trial
Tuesday December 2, 8:00 am ET
VANCOUVER, Dec. 2 /PRNewswire-FirstCall/ - Response Biomedical Corporation (TSX: RBM, OTCBB: RPBIF) announced the initiation of a clinical trial of the Company's RAMP® test to detect Respiratory Syncytial Virus (RSV). Prospective data from the clinical study is expected to be used to support a submission to the U.S. Food and Drug Administration (FDA) and other regulatory jurisdictions for market clearance of the 3M Rapid Detection RSV test for clinical use. The study is designed to demonstrate the performance characteristics of the RSV test versus standard laboratory culture and Direct Fluorescence Staining Assay (DFSA) for RSV using multiple sample types. The study is a multi-centre prospective clinical study to be conducted in North America at approximately eight clinical sites.
"We are excited to commence this clinical trial, which is the second clinical indication in infectious diseases developed for 3M Health Care," said S. Wayne Kay, Chief Executive Officer. "RSV is a very common disease that affects most children in their first two years of life. RSV is also common in the elderly and is often confused with influenza. There remains a significant clinical need for a rapid test that provides high clinical sensitivity for RSV compared to viral culture or DFSA."
The successful development of this test would allow physicians to quickly diagnose the presence or absence of RSV virus and optimize the clinical management of the RSV positive patient. A highly sensitive and rapid RSV test would allow more effective management of large RSV outbreaks and reduce the amount of unnecessary antibiotic administrations.
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 late 2006, the Company formed a strategic alliance with 3M to commercialize rapid infectious disease tests worldwide and in 2008 entered into a strategic alliance with Roche Diagnostics to commercialize rapid cardiovascular tests worldwide.
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. |
