FDA News

First gene-based test to detect the spread of breast cancer into lymph nodes approved by FDA

(July 17, 2007)-- Veridex, a Johnson & Johnson company, has announced U.S. Food and Drug Administration (FDA) approval of the first intra-operative and gene-based test to detect the spread of breast cancer into the lymph nodes. The GeneSearch Breast Lymph Node (BLN) Assay can detect the spread of cancer into the lymph nodes more accurately than existing rapid methodologies and, as a result, has the potential to reduce the need for stressful and costly second surgeries for breast cancer patients.

"Given that more than 40,000 women in the U.S. die from breast cancer annually, the demand for better medical care is extraordinarily high," said Pat Whitworth, M.D., director of the Nashville Breast Center and a principal investigator in the GeneSearch BLN clinical trials. "With this new molecular pathology test, we have an opportunity to improve the standard of care for women with this disease. Patients and physicians now can have a higher degree of confidence in their lymph node test results and, as a result, make more informed decisions about their treatment."

The GeneSearch BLN Assay is the first in vitro diagnostic test approved in the United States for the rapid detection of metastases greater than 0.2 mm in sentinel lymph node tissue removed from breast cancer patients. In clinical trials with more than 300 patients in the U.S. that compared performance of GeneSearch with commonly performed intra-operative test procedures, GeneSearch correctly identified 95.6 percent of patients who had metastases in their lymph nodes. This high accuracy in finding metastases was statistically superior to the most commonly performed intra-operative test procedure. The new, gene-based technology of the GeneSearch test allows for the analysis of 50 percent of the sentinel node, versus five percent of tissue typically examined under a microscope for evidence of cancer cells. Test results from GeneSearch can be produced in 35 to 40 minutes during the initial surgical procedure versus two to three days with tissue pathology.

Given its level of accuracy, GeneSearch has the potential to prevent the need for costly and traumatic second surgeries for as many as 5,200 additional breast cancer patients in the U.S. each year.1

"There is a need for a more accurate test to detect metastasized breast cancer in a woman's lymphatic tissue – and that's where the GeneSearch BLN Assay comes in," said Ken Berlin, general manager, Veridex. "We now have the opportunity to detect some metastases that could be missed by other tests. The end result is better patient management and better patient standard of care."

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