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news.Response Biomedical, a manufacturer and marketer of rapid on-site diagnostic tests, has filed an FDA 510(k) submission seeking clearance to market its respiratory syncytial virus, or RSV, test.
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According to Response Biomedical, the RSV test is a qualitative immunochromatographic assay indicated for use as an in vitro diagnostic product to identify the presence of the RSV antigen.
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.
Wayne Kay, CEO of Response Biomedical, said: “We believe we have a strong submission for review by the FDA. 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.”