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FDA Clears Veridex's Gene-Based Lymph Node Assay for Breast Cancer Metastasis

NEW YORK (GenomeWeb News) — Johnson & Johnson subsidiary Veridex said Tuesday that the US Food and Drug Administration has cleared its RT-PCR breast cancer assay that detects the spread of breast cancer in the lymph nodes.
 
Detecting breast cancer in the lymph nodes may offer faster and more accurate diagnoses of the spread of the disease, thereby potentially reducing the need for additional surgeries, Veridex said.
 
The intra-operative test, called the GeneSearch Breast Lymph Node assay, uses real time reverse transcriptase polymerase chain reaction technology with tissue extracted from a sentinel lymph node tissue sample to detect genes indicating metastasis of breast cells in the lymph node.
 
Conducted on Cepheid’s SmartCycler system, the test can generate results in 35 to 40 minutes compared with the two or three days for standard tissue pathology, Veridex said.
 
Veridex also said the GeneSearch enables surgeons to test up to 50 percent of the sentinel node, as opposed to only 5 percent typically examined under a microscope.
 
The test, which the company said correctly identified 95.6 percent of patients who had metastases in their lymph nodes in clinical trials of 300 women, also can be used to make real-time decisions in the operating room about whether to remove a lymph node, and could prevent the need for a second operation in as many as 5,200 breast cancer patients in the US per year.

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