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New York, NY – Federal regulators today approved a swift, new gene-based test that measures the spread of breast cancer into the lymph nodes, a diagnostic tool that could save thousands of unnecessary surgeries each year.
The test, called the GeneSearch BLN Assay, was developed by Veridex, a subsidiary of Johnson & Johnson. It can produce results in 45 minutes or less, with more accurate results than tests currently used in surgery to determine if cancer has spread to other parts of the body.
“Results of this rapid test are available while patients are on the operating table, providing a way for some women to avoid a second operation,” said Daniel Schultz, director of the Food and Drug Administration’s Center for Devices and Radiological Health.
One in eight women in the United States are at risk of developing breast cancer over the
course of their lives, and some 40,460 are projected to die from the disease this year [ap]