Response Biomedical Corporation (TSX: RBM, OTCBB: RPBIF) announced that it has received a notification from the U.S. Food and Drug Administration (FDA) that its NTproBNP Assay did not meet the criteria to obtain a waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
"We are obviously disappointed in the position of the US FDA in this matter, and would emphasise that this decision in no way diminishes the current perception of this product in the marketplace," said S. Wayne Kay, Chief Executive Officer. "The performance of our RAMP® NT-proBNP Assay has consistently been shown to be clinically concordant with that of the Roche Elecsys proBNP Test. The regulatory criteria for CLIA waiver have become significantly more stringent over the past few years, raising the bar to a level that few quantitative tests for clinically critical analytes may be able to achieve going forward."
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