The Immunology Devices Panel met Thursday, November 16, 2006, in Gaithersburg, Maryland, to provide advice and recommendation to the Food and Drug Administration regarding a premarket approval application (PMA P060017) for the Veridex GeneSearch BLN assay.
The GeneSearch BLN assay is a qualitative in vitro test for the rapid detection of clinically relevant (> 0.2 mm) metastases in lymph node tissue removed from breast cancer patients. Results from the assay can be used to guide the surgeon’s decision to excise additional lymph nodes and aid in patient staging.
The sponsor and FDA presented analyses of the pre-clinical and clinical study data to the advisory panel. Among items discussed were the clinical significance of the metastases detected by the assay, use of the assay as an intra operative stand-alone test (for example, as a replacement for diagnosis of frozen sections), false positive rates of the test, use of the test for staging disease, the practical impact of invalid assay results, and site to site variability of the assay results.
Two speakers that were involved in the clinical study expressed their views in favor of the assay during the open public session.
The industry and consumer representatives provided comments prior to panel deliberations and voting.
After deliberation, the PMA was recommended for “approval with conditions” by a 9 to 1 vote. The conditions included (1) several post-approval study and data requirements, (2) changes to labeling and the indications for use, (3) and improved training and education requirements.
All the panel members explained the reasons for their vote.
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