FDA Approves Lymph Node Test For Breast Cancer Patients

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FDA on Monday approved Johnson & Johnson subsidiary Veridex'stest called GeneSearch Breast Lymph Node Assay, which aims to detectcancerous growths in lymph node tissue removed from breast cancerpatients, the Boston Globe reports (Henderson, Boston Globe, 7/17).

GeneSearch also aims to help physicians decide whether more lymph nodes need to be removed. The test uses Cepheid'sSmartCycler system to identify cancerous growths that are at least 0.2millimeters in size by detecting the genes Mammaglobin and Cytokeratin19, which usually are seen at low levels in normal lymph node tissue,according to Veridex (Kaiser Daily Women's Health Policy Report,11/17/06). The test can produce results in 40 minutes or less, withmore accurate results than other tests used during surgery to determineif cancer has spread to other parts of the body, the Newark Star-Ledger reports (May, Newark Star-Ledger, 7/17). GeneSearch is expected to cost about $200, the Globe reports (Boston Globe, 7/17).

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Theagency said the approval was based on a clinical trial of 416 women.During the trial, GeneSearch correctly identified 88% of patients whosebreast cancer had spread. It also correctly identified 94% of women whohad no progression of the disease. Compared with results for immediatemicroscopic examination during surgery, GeneSearch had fewer falsenegative results but slightly more false positive results, according tothe agency.

The test "offers a new approach to sentinel-node testing," Daniel Schultz, director of FDA's Center for Devices and Radiological Health,said, adding, "Results of this rapid test are available while patientsare on the operating table, providing a way for some women to avoid asecond operation" (Corbett Dooren, Dow Jones/CNNMoney.com,7/16). The company estimates that the test could prevent as many as5,200 second surgeries for women who are misdiagnosed annually.

"Wenow have the opportunity to detect some metastases that could be missedby other tests," Ken Berlin, general manager of Veridex, said in astatement. He added, "The end result is better patient management andbetter patient standard of care." The company pledged to conduct twostudies to confirm the reliability and accuracy of the test, which willinvolve more than 1,000 women. The test already has been approved foruse in Europe (Newark Star-Ledger, 7/17).

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