Genetic test approval
This article was originally published in The Gray Sheet
Executive Summary
FDA approves PMA for a molecular assay manufactured by Johnson & Johnson/Veridex July 16 that helps evaluate the extent to which cancer might have spread from a breast tumor. The GeneSearch BLN Assay is a qualitative in vitro test for the intraoperative, rapid detection of clinically relevant metastases greater than 0.2 mm in lymph node tissue removed from breast cancer patients. It relies on the detection of two genetic markers that are expressed at high levels in breast cancer tissue but are typically at very low levels in nodal tissue (1"The Gray Sheet" Nov. 27, 2006, p. 10)...