Genesearch breast lymph node

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Peter W. Blumencranz said at a breast cancer symposium sponsored by the Cancer Therapy and Research Center. The thresholds employed in the assay reliably permit identification of metastases larger than 0.

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Skip to search form Skip to main content. We conducted a prospective clinical feasibility study of the GeneSearch Breast Lymph Node BLN Assay performed in SLNs from 97 patients by comparison with postoperative permanent section histopathology, to validate its potential usefulness in China. Every SLN was cut into alternating 1.

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The test was evaluated in terms of sensitivity and specificity, which measure how well the method correctly identifies nodes with and without clinically relevant metastases. Tests with lower sensitivity have a higher chance of false negatives, and tests with lower specificity have a higher chance of false positives. Sentinel lymph node biopsy SLNB is a widely used and accepted procedure in the management of breast cancer.

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Diagnostics guidance [DG8] Published date: August CK19 is normally not present in healthy lymph node tissue. The system does not need the mRNA to be extracted from the tissue and purified before analysis. Since the metastatic foci may not be evenly distributed throughout the node, the system provides more accurate results if more of the node is analysed because there is less risk of tissue allocation bias sample bias.

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Study record managers: refer to the Data Element Definitions if submitting registration or results information. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below.

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Skip to search form Skip to main content. Eighteen months clinical experience with the GeneSearch breast lymph node assay. View on PubMed.

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Skip to main content. Published: Jul 17, 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.

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This meta-analysis presents evidence regarding the diagnostic accuracy of mammaglobin detected using the RT-PCR technique, related to the presence of sentinel node metastasis in breast cancer patients. The selected studies presented the necessary data to calculate diagnostic validity index of mammaglobin detection using RT-PCR, compared with the reference standard test. Global values for the sensitivity, specificity, positive predictive value, negative predictive value, probability ratios, diagnostic ORs, and summary ROC curves of this meta-analysis were obtained using the Meta-DiSc 1. Initially, articles were obtained; but only 25 were included in the meta-analysis.

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Skip to main content. Published: Dec 18, In the study involving evaluable patients across 11 clinical trial sites, sentinel lymph nodes were tested using the GeneSearch TM BLN Assay and current methods for assessing nodal tissue during surgery frozen section FS or touch preparations TP.

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In the Dec. If the test shows the presence of cancer, the physician can remove affected lymph nodes immediately, sparing women the wait and possible follow-up surgery. The 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. In clinical trials with more than patients in the U.

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