Genomic Health Announces Publication of Clinical Outcomes Study for Biomarker Discovery Using Next Generation Sequencing

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Genomic Health Announces Publication of Clinical Outcomes Study for Biomarker Discovery... -- REDWOOD CITY, Calif., July 25, 2012 /PRNewswire/ --

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PLoS ONE Publication Establishes the Biological and Technical Validity of Proprietary RNA-Seq Method for Biomarker Discovery and Clinical Development

REDWOOD CITY, Calif., July 25, 2012 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: [ GHDX ]) today announced that the peer-reviewed journal PLoS ONE published positive results from its groundbreaking clinical outcomes study for biomarker discovery applying Next Generation Sequencing (NGS) for whole transcriptome profiling of archival formalin-fixed paraffin embedded (FFPE) tumor specimens.  Results demonstrated that Genomic Health's proprietary whole transcriptome RNA-Seq technology successfully rediscovered validated genes used in the Oncotype DX® breast cancer test that previously had been identified by RT-PCR, and discovered more than two thousand additional candidate biomarkers for future clinical research and development.

"These findings widen the lens of looking at cancer biology and represent the promise of Next Generation Sequencing as we consider the development of future tests," said Steve Shak, M.D., chief medical officer, Genomic Health.  "Based on these data, we are moving our NGS efforts forward to provide a comprehensive genomic platform for clinical research and development combining both whole transcriptome profiling and mutation analysis later this year."

As part of this study, Genomic Health scientists carried out whole transcriptome RNA-Seq on FFPE tumor RNA from a cohort of 136 breast cancer patients, which represents the largest RNA-Seq data set published to date.  The scientists examined patients' tumor tissue obtained at the time of surgery to identify associations between RNA-Seq measurement of expression and breast cancer recurrence.  These tumors were originally analyzed by RT-PCR in the biomarker discovery phase of the development of the Oncotype DX breast cancer test.  RNA-Seq refers to the use of massively parallel sequencing to generate a quantitative transcriptome expression profile for individual samples.  Using inputs of RNA of just 100 nanograms, Genomic Health applied the company's proprietary molecular methods to generate over 40 terabytes of data utilizing the Illumina® HiSeq 2000 instrument for subsequent bioinformatic and biostatistical analysis.

In addition to re-confirming the original 21 genes used in the Oncotype DX breast cancer test, which were previously identified by RT-PCR, this study also revealed more than 2,000 additional RNA transcripts associated with breast cancer recurrence.  A number of the RNAs associated with recurrence risk belong to novel RNA networks.

The article entitled, "Whole Transcriptome RNA-Seq Analysis of Breast Cancer Recurrence Risk Using Formalin-Fixed Paraffin-Embedded Tumor Tissue," (Sinicropi, D. et al. (2012) is available online at: [ http://dx.plos.org/10.1371/journal.pone.0040092 ].

About Genomic Health

[ Genomic Health ], Inc. (NASDAQ: [ GHDX ]) is a global health company that provides actionable genomic information to personalize genomic health decisions.  The company's lead product, the Oncotype DX® breast cancer test, has been shown to predict the likelihood of [ chemotherapy benefit ] as well as recurrence in invasive [ breast cancer ] and has been shown to predict the likelihood of recurrence in ductal carcinoma in situ (DCIS).  In addition to this widely adopted test, Genomic Health provides the Oncotype DX colon cancer test, the first multi-gene expression test developed for the assessment of risk of recurrence in patients with stage II and stage III disease.  As of March 31, 2012, more than 10,000 physicians in over 65 countries had ordered more than 275,000 Oncotype DX tests.  Genomic Health has a robust pipeline focused on developing tests to optimize the treatment of prostate and renal cell cancers, as well as additional treatment decisions in breast and colon cancers.  The company is based in Redwood City, California with European headquarters in Geneva, Switzerland.  For more information, please visit, [ www.GenomicHealth.com ]. To learn more about Oncotype DX tests, visit: [ www.OncotypeDX.com ] and [ www.mybreastcancertreatment.org ].

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the company's prospects for its next generation cancer diagnostic platforms and programs; the timing of the availability of its planned next generation platforms; the attributes of its next generation platforms to biomarker discovery and utility as a diagnostic tool; the focus of the company's product pipeline, including the abilityof the company to develop additional tests in the future, and the ability of any potential tests the company may develop to optimize cancer treatment and impact clinical practice.  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 applicability of initial next generation sequencing studies to future results; our ability to develop a comprehensive genomic platform for clinical research and development and the timing thereof; our ability to compete against third parties in the development of next generation sequencing technologies; unanticipated costs or delays in research and development efforts; the risks and uncertainties associated with the regulation of our tests by the FDA and other agencies abroad; the results of clinical and developmental studies; the applicability of clinical study results to actual outcomes; our ability to obtain capital when neededand 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 period ended March 31, 2012.  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, Recurrence Score, and DCIS 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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