Genomic Health, Inc.
Dec 9, 2014
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Genomic Health Advances Development of Novel Liquid Biopsy-Based Cancer Tests

Presentations at SABCS and SUO Reveal Company's Ability to Detect Breast and Bladder Cancers in Blood and Urine, Respectively

SAN ANTONIO, Dec. 9, 2014 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced positive results from its first two feasibility studies assessing multiple technologies, including next-generation sequencing, for their ability to detect and characterize the presence of bladder cancer DNA in urine and breast cancer DNA in blood. 

The presentations of these initial encouraging results at the 2014 San Antonio Breast Cancer Symposium (SABCS) and the 2014 Society of Urologic Oncology (SUO) Annual Meeting represent an important milestone as Genomic Health pursues the development of standardized non-invasive tests that can provide an ongoing evaluation of a patient's cancer to obtain quantitative real-time insights to inform treatment planning throughout the cancer patient's journey, from diagnosis to treatment selection and monitoring.  

"The ability to determine the presence of disease or the development of drug resistance holds huge promise for individualizing care at multiple points throughout a cancer patient's journey," said Kim Popovits, chairman of the board, chief executive officer and president of Genomic Health. "The positive results from these two studies represent an important step toward achieving our goal of once again revolutionizing the way cancer is treated by offering standardized non-invasive liquid biopsy tests to analyze multiple tumor-derived genomic signatures."

Solid tumors that originate in internal organs such as the breast or bladder often release DNA and tumor cells into the bloodstream or urine. When the presence of tumor-derived DNA in blood is high and persists or increases over time, the cancer is likely growing and a new course of treatment may be appropriate.

"Liquid biopsies have the potential to successfully measure the presence and burden of cancer, as well as the sensitivity or resistance to specific drugs," said Steven Shak, M.D., executive vice president of research and development, Genomic Health. "We believe our ability to assess cancer DNA in a non-invasive liquid-biopsy sample to monitor the genomic alterations as they occur in response to therapy or simply over the course of the disease will transform the way cancer is treated, monitored and managed."

In the two separate studies, Genomic Health researchers used the company's NGS- and PCR-based technologies and methods to detect tumor DNA and tumor DNA alterations in urine and blood. Three major alteration types were studied across various stages of breast and bladder cancers. Specifically, to identify the most accurate and efficient approach to detect cancer presence in a tumor sample, the company examined DNA copy number aberrations (CNAs), DNA methylation variations, and DNA single nucleotide variations (SNVs). 

Based on these promising results, Genomic Health is conducting larger-scale proof-of-concept studies investigating analytical methods that would enable accurate and scalable genomic analysis of liquid biopsies in breast and bladder cancer patients.  The company plans to introduce its first liquid biopsy-based test in 2016.

The upcoming SABCS presentation, titled "Global quantitative measures using next-generation sequencing for breast cancer presence outperform individual tumor markers in plasma," (Abstract P4-02-08) will take place on Friday, December 12, 7:30 - 9 a.m. Central Time in Exhibit Halls A-B of the Henry B. Gonzalez Convention Center in San Antonio.

About Genomic Health
Genomic Health, Inc. (NASDAQ: GHDX) is the world's leading provider of genomic-based diagnostic tests that address both the overtreatment and optimal treatment of early-stage cancer, one of the greatest issues in healthcare today. The company is applying its world-class scientific and commercial expertise and infrastructure to lead the translation of massive amounts of genomic data into clinically-actionable results for treatment planning throughout the cancer patient's journey, from diagnosis to treatment selection and monitoring.  The company is based in  Redwood City, California with European headquarters in Geneva, Switzerland. For more information, please visit www.GenomicHealth.com and follow the company on Twitter: @GenomicHealth, Facebook and LinkedIn.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the attributes and benefits of the company's tests to physicians and patients; the company's  belief that the study results represent an important step toward achieving a goal of revolutionizing the way cancer is treated; the attributes and focus of the company's product pipeline; the company's belief that it is applying its infrastructure and expertise to lead the translation of genomic data into clinically actionable results; and the applicability of clinical study results to actual outcomes. 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 the company's tests; the results of clinical studies; the applicability of clinical study results to actual outcomes; our ability to develop and commercialize new tests and expand into new markets domestically and internationally; the risk that the company may not obtain or maintain sufficient levels of reimbursement, domestically or abroad, for its existing tests and any future tests it may develop; the risks of competition; unanticipated costs or delays in research and development efforts; the company's ability to obtain capital when needed 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, 2014 . 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.

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