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Genomic Health Announces Results from Biomarker Discovery Program Utilizing Next-Generation Sequencing to Compare Normal and Tumor Breast Tissue
"These results demonstrate the use of next-generation sequencing of formalin-fixed tissue to accelerate testing of hypotheses for biomarker discovery," said Joffre Baker, Chief Scientific Officer at
The study was designed to compare gene expression profiles between 12 normal and 12 tumor formalin-fixed (FFPE) breast specimens — all of which were 10-13 years old. Each sample, on average, yielded 19 million base pairs of DNA with approximately 85 percent mapping to unique sites in the human genome. Further analysis showed that 3,584 coding genes were differentially expressed between tumor and normal specimens. The association of each of these with the risk of breast cancer recurrence was sought by consulting published gene expression results from approximately 3,000 patients with breast cancer tumors for which there was a record of clinical outcome. This analysis showed that sets of transcripts over-expressed in tumors compared with normal tissues produced only a modest enrichment for prognostic significance, but further evaluation of these transcripts by gene set analysis produced a set that is highly enriched for prognostic genes.
In addition, an algorithm was developed to detect and quantify transcripts from non-coding regions of the genome and through this process more than 1,000 differentially expressed non-coding sequences were identified. Reverse transcriptase-polymerase chain reaction (RT-PCR) assays were designed for a number of the non-coding transcripts and were used to screen a 136 patient cohort of breast cancer specimens. Several of these non-coding RNAs proved to be associated with breast cancer recurrence risk.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to our ability to generate similar results in further studies, the clinical utility of preliminary biomarkers; our ability to develop whole transcriptome and/or genome expression analysis for routine clinical study; the belief that whole genome expression may accelerate clinical or biomarker discovery; our ability to develop, validate or commercialize advanced diagnostics based upon such genome expression data; the timing of such studies and results; and the company's ability to accelerate its research and development efforts to move whole genome expression technology into clinical studies. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported
results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the risks and uncertainties associated with the regulation of our tests; the applicability of clinical study results to actual outcomes; the risks and potential delays associated with such studies; and the other risks set forth in the company's filings with the
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