FDA clears J&J rapid breast cancer test |
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Published
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Mon, 16 Jul 2007 22:26 |
WASHINGTON (AP) - Food and Drug Administration officials said Monday they approved a novel genetic test developed by Johnson & Johnson that rapidly detects the spread of breast cancer.The GeneSearch BLN Assay, made by Johnson & Johnson company Veridex, is designed to quickly tell physicians whether cancerous cells have spread from the breast to surrounding lymph nodes.The laboratory tests can diagnose cancer in lymph nodes in about 30 minutes, allowing surgeons to remove them immediately. Currently, physicians often wait one or two days to get results from tissue samples, and then must perform follow-up surgery when the cancer is detected.In company studies, GeneSearch accurately predicted the spread of breast cancer about 88 percent of the time. The test accurately identified patients whose cancer had not spread 94 percent of the time.The test is the first molecular-based laboratory test for detecting whether breast cancer has spread to nearby lymph nodes, according to the FDA.Shares of Johnson & Johnson added 37 cents to $63.80.Copyright 2007 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
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