Response Biomedical initiates respiratory syncytial virus infection trial

Prospective data from the clinical study is expected to be used to support a submission to the FDA and other regulatory jurisdictions for market clearance of the 3M Rapid Detection respiratory syncytial virus (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.

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, the company said.

Wayne Kay, CEO of Response Biomedical, said: “We are excited to commence this clinical trial, which is the second clinical indication in infectious diseases developed for 3M Health Care. There remains a significant clinical need for a rapid test that provides high clinical sensitivity for RSV compared to viral culture or DFSA.”