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In Brief: Biomira Truquant BR

This article was originally published in The Gray Sheet

Executive Summary

Biomira Truquant BR: Blood test kit for detection of recurrent breast cancer will be reviewed at FDA's Immunology Devices Panel meeting scheduled for Sept. 21 in Gaithersburg, Maryland, Biomira Diagnostics says. A premarket approval application for the assay, filed in April, has been granted expedited review by the agency. The second day of the panel meeting, which was to include panel review of "an in situ hybridization assay to measure a prognostic marker in breast tumor tissues," has been canceled, according to FDA. Panel review of an assay to measure a urinary marker in order to aid in the detection of recurrence in bladder cancer patients remains on the agenda for Sept. 21...
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