Response Biomedical Corporation Initiates Respiratory Syncytial Virus Infection Clinical Trial
News Dec 03, 2008
Response Biomedical Corporation 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," Kay said.
The successful development of this test would allow physicians to diagnose the presence or absence of RSV virus and optimize the clinical management of the RSV positive patient.