Molecular Test Detects Breast Mets
Veridex, a Johnson and Johnson subsidiary, launched a new in vitro molecular test to detect extension of breast cancer, metastases to the lymph nodes. The product was granted FDA approval on July 16th.
The GeneSearch BLN Assay assesses tissue samples for the presence of molecules normally found in breast tissue. The presence of these in lymph nodes is highly associated with metastatic breast cancer of the lymph nodes.
The test was designed to evaluate the presence of these molecules in sentinel nodes, which are frequently removed for examination when patients undergo definitive surgery for breast cancer. The assay can be completed rapidly, while the patient is undergoing surgery, which can inform intra-operative decision making.
With information available at the time of surgery, additional tissue can be removal at that time if necessary. This can reduce the likelihood of performing a second surgery to remove metastatic disease.
Findings submitted to receive FDA approval indicate a rate of 88 percent when predicting those patients with sentinel node disease and 94 percent accuracy identifying patients without. Compared to standard pathologic examination completed intraoperatively, GeneSearch was less likely to produce false negatives, but false positive results increased.
The product provides breast surgeons key information during surgery. Another product, launched by Dune Medical Devices, evaluates surgical margins during surgery.
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- Breast Biopsy System for MRI Updated
- SenoRx Lumpectomy Device to Hit Market Next Year
- Her2/neu Software Approved
July 17, 2007 Related topics: New Technology & Innovation, Laboratory Equipment, Surgery