Genomic Health Announces Results from Two Studies Demonstrating Innovations in Next Generation Sequencing From Paraffin Tissue,

Genomic Health Announces Results from Two Studies Demonstrating Innovations in
 Next Generation Sequencing From Paraffin Tissue, Enhancing Understanding of
                                Tumor Biology

Results Presented at the 14th Annual Advances in Genome Biology and Technology
Meeting Reveal Novel Method for RNA-Sequencing and Mutation Identification

PR Newswire

REDWOOD CITY, Calif., Feb. 25, 2013

REDWOOD CITY, Calif., Feb. 25, 2013 /PRNewswire/ --Genomic Health, Inc.
(Nasdaq: GHDX) today announced the results of two studies demonstrating that
DNA strand-of-origin information can help further refine the identification of
prognostic biomarkers, and that tumor specific gene mutations can be
effectively examined using archival fixed paraffin embedded tumor (FPET)
tissue, enabling an improved and more practical process of tumor analysis.
These new findings were presented at the 14th Annual Advances in Genome
Biology and Technology (AGBT) meeting in Marco Island, Fla.

"Our continued research efforts demonstrate the biological and technical
capabilities of our advanced next generation sequencing (NGS) methods for
biomarker discovery and validation," said Steven Shak, M.D., chief medical
officer and executive vice president for research and development at Genomic
Health. "These findings will accelerate the development of future tests based
on our ongoing clinical research that combines both whole transcriptome
profiling and mutation analysis."

Novel Next Generation Sequencing and Bioinformatics Methods Enhance Biomarker

  oBuilding on study results published in PLoS One -- where Genomic Health
    scientists carried out whole transcriptome RNA-Seq on FPET RNA from a
    cohort of 136 breast cancer patients -- this analysis evaluated the impact
    of DNA strand-of-origin information on the identification of prognostic

During DNA transcription, only one of the two double-stranded DNA molecules is
used as a template for an RNA transcript and protein production. Analytic
approaches that do not consider the strand-of-origin of RNA sequencing data
can be limited in their accuracy in assigning reads to human genes.
Therefore, to perform this study, Genomic Health scientists developed a
proprietary NGS and bioinformatics approach to produce a more definite
specification of the strand-of-origin of the RNA transcript. The application
of this method enabled more precise detection of expressed genes that were
significantly associated with breast cancer recurrence, and permitted the
identification of 228 additional candidate genes associated recurrence risk in
breast cancer.

Enabling Detection of Tumor Specific Mutations Using FPET to Improve Precision
of Cancer Diagnosis

  oReliable differentiation between inherited variations in DNA (germline
    mutations) and tumor specific variations in DNA (somatic mutations) plays
    a key role in determining the accuracy and precision of cancer genome
    sequencing. However, optimally, determination of germline mutations
    requires the presence of the blood samples in addition to the FPET
    specimen. This new study showed that by utilizing Genomic Health's
    proprietary NGS methods to analyze archival FPET specimens, the company
    can now reliably detect germline variants and tumor specific mutations
    when the patient's blood sample is not available.

As part of this study, 190 frequently mutated cancer genes were sequenced
using the Illumina HiSeq™ 2000 System from FPET blocks, analyzing both the
patient's tumor tissue and adjacent non-tumor tissue. Similar sequence
analysis was performed on patient-matched blood samples. Readily-available
adjacent non-tumor tissue in the FPET specimen was a sufficient alternate
source of germline variants to enable the accurate detection of
cancer-specific somatic mutations in the tumor.

"Individual patients have an abundance of unique somatic mutations which
underscores the heterogeneity of cancer and the importance of gaining better
understanding of individual tumor biology for more accurate diagnosis," said
Samuel Levy, Ph.D., Genomic Health's chief scientific officer. "By applying
this technique to work with patients' archival FPET tissue to identify and
account for germline variants, we can learn more from the FPET tumor tissue
saved from landmark clinical studies when matched blood samples are not

AboutGenomic Health

Genomic Health, Inc. (NASDAQ: GHDX) is a global healthcare company that
provides actionable genomic information to personalize cancer treatment
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
December 31, 2012, more than 10,000 physicians in over 65 countries had
ordered approximately 335,000 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, To learn more about Oncotype DX tests, visit: and

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 our next generation sequencing capabilities; 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; the company's ability to accelerate its
research and development efforts to move whole genome expression technology
into clinical studies and; the company's ability to obtain intellectual
property protection for such discoveries. 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, 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

SOURCE Genomic Health, Inc.

Contact: Investors, Dean Schorno, Genomic Health, 650-569-2281,; or Media, Victoria Steiner, Genomic Health,
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