<p class="MsoNormal" style="text-justify: inter-ideograph; text-align: justify; line-height: normal; margin: 0cm 0cm 0pt;"><strong style="mso-bidi-font-weight: normal;"><span style="font-family: "Times New Roman"; font-size: 10pt;" lang="EN-US">Background</span></strong></p><p class="MsoNormal" style="text-justify: inter-ideograph; text-align: justify; line-height: normal; margin: 0cm 0cm 0pt;"><span style="font-family: "Times New Roman"; font-size: 10pt;" lang="EN-US">Sentinel lymph node biopsy (SLNB) is the current standard of care for lymphatic staging in early breast cancer patients. The combination of a SLNB with an intra-operative diagnosis of the SLNB enables a single staged procedure, avoiding a delayed axillary lymph node dissection (ALND) in node positive patients. The current conventional pathological techniques are resource intensive, require expert personnel and are not routinely used in many breast units.</span></p><p class="MsoNormal" style="text-justify: inter-ideograph; text-align: justify; line-height: normal; margin: 0cm 0cm 0pt;"><strong style="mso-bidi-font-weight: normal;"><span style="font-family: "Times New Roman"; font-size: 10pt;" lang="EN-US">Methods</span></strong></p><p class="MsoNormal" style="text-justify: inter-ideograph; text-align: justify; line-height: normal; margin: 0cm 0cm 0pt;"><span style="font-family: "Times New Roman"; font-size: 10pt;" lang="EN-US">GeneSearch™ BLN assay is a RT-PCR technique calibrated to detect SLN metastases of >0.2mm. It is designed to detect 2 clinically validated genes Mammaglobin (MG) and Cytokeratin – 19 to provide a rapid diagnosis.The SLN identification was by the combined technique using radiocolloid and patent blue dye. The excised SLNs were sliced in their short axis at intervals of 1.5 mm to 2 mm. The sections were numbered and alternate sections were processed for histopathology and RT-PCR assay.The study was conducted in 2 phases. The first phase was to evaluate the accuracy and feasibility of RT-PCR assay as an intra-operative diagnostic test. The second phase was the real time application of the results to inform decision regarding immediate ALND.</span></p><p class="MsoNormal" style="text-justify: inter-ideograph; text-align: justify; line-height: normal; margin: 0cm 0cm 0pt;"><strong style="mso-bidi-font-weight: normal;"><span style="font-family: "Times New Roman"; font-size: 10pt;" lang="EN-US">Results</span></strong><strong style="mso-bidi-font-weight: normal;"></strong></p><p class="MsoNormal" style="text-justify: inter-ideograph; text-align: justify; line-height: normal; margin: 0cm 0cm 0pt;"><span style="font-family: "Times New Roman"; font-size: 10pt;" lang="EN-US">This prospective study comprised of 166 patients with 164 females and 2 male...
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