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Genomic Health Announces Data Confirming Manual Microdissection of Biopsy Cavities Is Essential for Accurate Recurrence Risk Assessment in Early-Stage Breast Cancer Patients
Date:10/9/2009

form that assesses risk of recurrence by examination of tumor tissue."

The study assessed 53 invasive breast carcinomas (19 well-, 19 moderately-, and 15 poorly-differentiated) to determine differences in gene expression between whole sections that contained biopsy cavities, enriched tumors where biopsy cavities were excluded and the dissected biopsy cavities. Standardized quantitative reverse transcription polymerase chain reaction (RT-PCR) analysis for the 21 genes was performed.

The results indicated that there was a statistically significant average increase in the Recurrence Score result for whole sections versus enriched tumors (5.35 Recurrence Score Units; p < .0001). There were also statistically significant differences in reference normalized gene expression between enriched tumor and whole sections in 12 of the 16 cancer-related genes. Additionally, biopsy cavities tended to have high-risk Recurrence Scores.

"Careful histologic review of each patient case by a board-certified surgical pathologist and manual microdissection to remove all biopsy cavities when necessary has been standard practice in our lab since the Oncotype DX test became available in 2004," said Rick Baehner, MD, director of pathology at Genomic Health and assistant professor of clinical pathology at the University of California San Francisco Medical Center. "This study underscores the critical role that expert pathologists play in working with the clinical laboratory to provide the most accurate molecular assessment of individual tumors so that physicians and patients can make well-informed individual treatment decisions."

Also presented at this week's Breast Cancer Symposium were results of a multi-center Japanese study demonstrating that the Oncotype DX breast cancer test had significant prognostic value in Japanese women with estrogen receptor-positive early-stage breast cancer. In this study that was originally presente
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SOURCE Genomic Health, Inc.
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