GeneSearch Lymph Node Test Gets Nod For Breast Cancer Assessment
This article was originally published in The Gray Sheet
Executive Summary
A molecular assay that helps evaluate the extent cancer might have spread from a breast tumor was recommended for approval by FDA's Immunology Devices Panel Nov. 16
You may also be interested in...
Genetic test approval
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)...
FDA budget
Both the Senate and House Appropriations Committees clear FDA fiscal 2008 funding bills July 19. The Senate bill includes $243.3 million for the device center, about $3 million more than the president requested in February (1"The Gray Sheet" Feb. 12, 2007, p. 3). The House matched the administration's request with a $240.1 million appropriation to CDRH. The Senate committee approved total FDA appropriations of $1.76 billion, slightly more than the House's $1.69 billion. Agency spending will also likely include about $48.5 million in device user fees, though user fee reauthorization legislation is still awaiting the outcome of a House-Senate conference (2"The Gray Sheet" July 16, 2007, p. 4). The House appropriations bill includes language preventing FDA from allowing individuals with financial conflicts to participate in advisory panel meetings. The provision has been included in funding bills for the past two years but has always been removed or weakened before final passage...
Genetic test approval
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)...