Health Canada grants Response Biomedical Class 3 Medical Device license for RAMP RSV Assay

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Response Biomedical Corporation (TSX: RBM; OTCBB: RPBIF) today announced that it has been granted a Class 3 (near patient/point-of-care) Medical Device license by Health Canada to market its RAMP® Respiratory Syncytial Virus (RSV) Assay in Canada.

“We are very pleased to receive country of origin approval to market the RSV test in Canada”

The test, manufactured by Response Biomedical, runs on the RAMP® 200 Reader and is a qualitative immunochromatographic assay indicated for use as an in vitro diagnostic product to detect the presence of RSV F-protein antigens in nasopharyngeal swab, nasopharyngeal aspirate, or nasal wash/aspirate specimens at the point-of-care. Measurement of RSV aids in the rapid diagnosis of RSV viral infections in symptomatic patients. RSV is the most common cause of severe lower respiratory tract disease among infants and young children. Persons at increased risk for severe disease or death include premature infants, older adults, and persons of any age with compromised respiratory, cardiac, or immune systems. RSV is transmitted from person to person via close contact, droplets, or fomites. In temperate climates, peak RSV activity typically occurs during the winter. However, year-to-year national and regional variability in the RSV season onset and offset occurs in North America. Appropriately timed diagnostic tests can provide data that indicate when the RSV season begins, information that has been critical in determining when to begin RSV prophylaxis for infants and children at high risk for infection.

"We are very pleased to receive country of origin approval to market the RSV test in Canada," said S. Wayne Kay, CEO of Response Biomedical. "Health Canada approval of our rapid RSV test adds another product to the RAMP® platform that addresses the growing need for detecting upper respiratory infections, and assists greatly in our ability to achieve further global registrations and expand the market for this product. For instance, country of origin approval allows us to market the product in many other international jurisdictions that accept such an approval as the regulatory requirement in their country. This license also allows our other Class 3 Assays, which includes all of our cardiac products, to be run on the RAMP® 200 Reader in Canada."

Currently available methods for diagnosis of RSV infections include cell culture, serology, and direct examination of respiratory secretions. These include electron microscopy, indirect and direct immunofluorescent antibody tests (DFA), enzyme-linked immunoassays (EIAs), and nucleic acid amplification (e.g. polymerase chain reaction (PCR)). The RAMP® advantage to the competitive point-of-care products on the market is the unbiased Reader interpretation, rather than a subjective visual interpretation, as well as connectivity to laboratory information systems.


The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
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