Genomic Health Announces Initiation of Clinical Validation Study of Prostate Cancer Test; Acceleration of Next Generation Sequencing Program

REDWOOD CITY, Calif., Jan. 9, 2012 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced that it has started a large clinical validation study of its prostate cancer test.  The study, being performed in collaboration with leading prostate cancer researchers at the University of California, San Francisco (UCSF), is designed to determine if a multi-gene test can help distinguish aggressive disease requiring surgery from less aggressive disease that may undergo active surveillance in patients with early-stage prostate cancer. The study will utilize Genomic Health's proprietary RT-PCR process for analyzing very small amounts of formalin-fixed paraffin-embedded (FFPE) prostate tissue obtained by needle biopsy prior to removal of the prostate. Complete results are expected to be presented at the end of this year or early next year, and if positive, are expected to support the launch of the Oncotype DX® prostate cancer test in 2013.

"Moving our prostate cancer test into the final stage of clinical validation, combined with the recent successful launch of our Oncotype DX DCIS Score and MMR colon cancer testing service, reflects our ability to deliver better outcomes for cancer patients," said Kim Popovits, President and Chief Executive Officer, Genomic Health.  "Once validated, we believe the Oncotype DX prostate cancer test will provide physicians and prostate cancer patients with much needed information for making treatment decisions, similar to what our tests for breast and colon cancer do today."

The company also announced that it is accelerating its Next Generation Sequencing (NGS) program by moving it into clinical development studies that will examine both RNA-Seq expression and mutation analysis. This decision comes after the company successfully conducted the first clinical outcomes study for biomarker discovery using NGS for whole transcriptome profiling of archival FFPE tumor specimens.  Results of this study were presented at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium in December.  In addition, informatics infrastructure investments to support a cloud-based system for storage and analysis of large genomic data sets are underway.   The NGS technology allows Genomic Health scientists to assay the entire genome simultaneously to discover regions of the genome whose expression is associated with clinical outcomes and treatment response. 

"In the future, we believe physicians and patients will require a comprehensive genomic analysis including gene expression as well as specific mutations to better inform treatment decisions," said Steve Shak, M.D., Chief Medical Officer, Genomic Health.  "We believe our proven ability to translate genomic data into actionable clinical information positions Genomic Health to lead the clinical application of next generation sequencing."

Kim Popovits, Genomic Health's Chief Executive Officer, will provide a business update today at 9:30 a.m. PT at the 30th Annual JP Morgan Healthcare Conference highlighting the company's achievements and its priorities for 2012.  

To access the live and subsequently archived webcast of the presentation, visit the Investor Relations section of Genomic Health's website at http://investor.genomichealth.com.  Please connect to the website at least 15 minutes prior to the beginning of the presentation to allow for any necessary software downloads.  An archived replay will be available for three months beginning 24 hours after the live presentation.

About Genomic Health and the Oncotype DX® Tests
Genomic Health, Inc. (NASDAQ: GHDX) is a global cancer company focused on the development and commercialization of genomic-based clinical laboratory services that analyze the underlying biology of cancer allowing physicians and patients around the world to make individualized treatment decisions.

Its lead product, the Oncotype DX Breast Cancer test, has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in early-stage breast cancer to help optimize treatment options.  Oncotype DX is the only test incorporated in published ASCO® and NCCN® breast cancer treatment guidelines for patients with node-negative breast cancer that is estrogen-receptor positive and/or progesterone-receptor positive.(1) The test is also recognized in international guidelines issued by St. Gallen International Breast Cancer Expert Panel and European Society for Medical Oncology (ESMO).

Physicians also use the Oncotype DX Breast Cancer test to make treatment recommendations for certain node-positive breast cancer patients.  Oncotype DX has been extensively evaluated in thirteen clinical studies involving more than 4,000 breast cancer patients worldwide, including a large validation study published in The New England Journal of Medicine and a chemotherapy benefit study published in The Journal of Clinical Oncology.

The Oncotype DX Colon Cancer test is the first multigene expression test commercially available that has been clinically validated to predict risk of recurrence in patients with stage II colon cancer.  Genomic Health collaborated with the National Surgical Adjuvant Breast and Bowel Project and Cleveland Clinic on a total of four development studies in more than 1,800 to analyze patients with stage II colon cancer.  The final gene panel was then independently evaluated in more than 1,400 stage II colon cancer patients in the QUASAR validation study.

As of December 31, 2011, more than 10,000 physicians in over 60 countries had ordered more than 250,000 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 stages of 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 prostate cancer studies and future prostate cancer tests; 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 company's prospects to lead the industry in the development of such applications; the focus of the company's product pipeline, including the ability of the company's tests to 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 results of clinical and developmental studies; the applicability of clinical study results to actual outcomes; our ability to develop and commercialize new tests and the timing thereof; unanticipated costs or delays in research and development efforts; the applicability of initial next generation sequencing studies to future results; the risk that we may not obtain or maintain sufficient levels of reimbursement for our existing tests and any future tests we may develop, both domestically and abroad;  our ability to compete against third parties; the risks and uncertainties associated with the regulation of our tests by the FDA and other agencies abroad; 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 period ended September 30, 2011. 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.

(1) ASCO and NCCN are registered trademarks of the American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN), respectively.  ASCO and NCCN do not endorse any product or therapy.

SOURCE Genomic Health, Inc.