Gene-Based Lymph-Node Assay Guides Breast Surgery

An intra-operative, gene-based diagnostic test that detects the spread of breast cancer to the lymph nodes has been launched in Europe.

Using real time-reverse transcriptase polymerase chain reaction (RT-PCR) technology, the test detects genes that indicate metastasis of breast cells in the lymph node. This genetic technology provides a rapid, standardized, objective result, reducing errors and improving reproducibility. The test can easily be performed by trained laboratory technicians, offering advantages to hospitals where pathologists are very busy or are not available.

The in vitro diagnostic test detects clinically relevant (0.2 mm) metastases in sentinel lymph node tissue removed from the breast cancer patient. Test results are reported within 30 to 40 minutes from the time the sentinel nodes are removed, versus a two-to-three day wait for results from current permanent section histology. Results from the test can be used to guide the decision to excise additional lymph nodes and to aid in patient staging. If there is no evidence of cancer in the sentinel node, it is highly unlikely that the cancer has spread to other nodes, and there may be no need for further surgery.

The CE-marked GeneSearch breast lymph node (BLN) test developed by Veridex (Warren, NJ, USA) offers an advanced alternative to more-conventional tissue pathology. The test can be performed intra-operatively and will help pathologists provide surgeons with accurate information to help them determine whether they need to perform a simple lumpectomy or a more complex axillary lymph node dissection.

Mark Myslinski, general manager of Veridex said, "By using molecular biology to guide surgeons in the operating room, second surgeries can be prevented. We believe that the combined benefits of this test--improved patient outcomes and lowered healthcare costs--underscore its value to the medical community.”

Veridex, a Johnson & Johnson company, develops cancer diagnostic products that enable earlier disease detection as well as more accurate staging, monitoring, and therapeutic selection. The company's two complementary product lines are CellSearch assays that identify, enumerate, and characterize circulating tumor cells directly from whole blood, and GeneSearch assays that use molecular technology to diagnose, stage, and more accurately characterize tumors.



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