Response Biomed Corp RPBIF

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[dimar66]

We could have used good news on this, but it has been so long in the works most people have given up expecting anything.  So it is mostly factored into the share price already.
Vancouver, British Columbia, June 13, 2011 – 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.”