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Genomic Health Develops New Methods for Whole Genome Expression Analysis of Standard Pathology Tumor Specimens

Monday, March 1, 2010 General News J E 4
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REDWOOD CITY, Calif., March 1 Genomic Health, Inc. (Nasdaq: GHDX) today announced that its research scientists have developed a clinically useful method for whole genome expression analysis using standard tumor specimens that are routinely collected in clinical practice. Genomic Health is now able to access the entire transcriptome, or all of the RNA that is made by cells, in order to quantify the gene expression profile in a single assay using next generation DNA sequencing technology developed by Illumina. Results demonstrating the successful whole genome expression and mutation analysis from formalin fixed, paraffin-embedded (FFPE) tumor samples were presented last week at the 11th Annual Advances in Genome Biology and Technology (AGBT) meeting in Marco Island, Florida.

"We have developed proprietary technology that allows whole genome expression analysis from very small amounts of RNA contained in standard pathology specimens," said Dominick Sinicropi, Senior Scientist at Genomic Health. "The ability to conduct genome-wide expression analysis on archival samples should accelerate clinical discovery and validation of advanced diagnostics for the many different types of cancer that are diagnosed today."

The study was designed to compare expression profiles between two estrogen receptor positive and estrogen receptor negative breast cancer FFPE specimens that were 7-8 years old. The RNA from these types of samples is highly fragmented and available in minute quantities, making it extremely difficult to conduct expression analysis on a genome-wide scale until now.

In the study, scientists were able to successfully extract, amplify, purify and sequence the complete transcriptome from these FFPE tissues using new RNA preparation chemistry developed by Genomic Health scientists specifically for these types of samples. Up to 18 million RNA transcripts from the individual tumor specimens were sequenced resulting in both expression profiles and mutation data on more than 25,000 protein coding genes as well as tens of thousands of non-coding transcripts.

"These results suggest that it may soon be technically and economically feasible to use whole genome expression analysis in large clinical trials utilizing routine pathology specimens leading to real commercial applications that may ultimately benefit cancer patients," said Joffre Baker, Chief Scientific Officer at Genomic Health. "With that goal in mind, we intend to accelerate our research and development efforts to move this new technology into clinical studies."

About Genomic Health

Genomic Health, Inc. (NASDAQ: GHDX) is a life science company focused on the development and commercialization of genomic-based clinical laboratory services for cancer that allow physicians and patients to make individualized treatment decisions. In 2004, Genomic Health launched the Oncotype DX(R) breast cancer test, which has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in early-stage breast cancer. In addition to the widely adopted Oncotype DX breast cancer test, Genomic Health launched its Oncotype DX colon cancer test in January 2010. The company was founded in 2000 and is located in Redwood City, California. For more information, please visit www.genomichealth.com.

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, our ability to develop whole genome expression analysis for routine clinical study; the belief that whole genome expression may accelerate clinical discovery and validation of advanced diagnosticst or result in commercial applications; the proposed 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 Securities and Exchange Commission, including the risks set forth in the company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2009. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.

NOTE: The Genomic Health logo, Oncotype, Oncotype DX and Recurrence Score are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.

SOURCE Genomic Health, Inc.
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