Response Biomedical Corp announced that it has filed an 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™ 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 US, 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.

Source: Response Biomedical