Genomic Health Advances Liquid Biopsy Pipeline, Shows Ability to Accurately Monitor Urine for Presence of Bladder Cancer

REDWOOD CITY, Calif., May 18, 2015 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced positive results from a second, larger liquid biopsy feasibility study demonstrating the Company's ability to detect tumor-specific DNA in urine, which is expected to enable bladder cancer recurrence monitoring. The study results, which were presented at the 2015 American Urological Association (AUA) Annual Meeting in New Orleans, included data from 66 patients who are part of a large ongoing study that has enrolled nearly 500 patients at 15 sites.

"A non-invasive, urine-based test for monitoring patients for disease recurrence can improve bladder cancer patient care by optimizing the use of cystoscopies," said Matthew J. Resnick, M.D., assistant professor and urologic surgeon, Vanderbilt University Medical Center, Nashville, Tenn. "A liquid biopsy could make it less stressful for low-risk patients to comply with active surveillance, while aiding in earlier detection and more timely treatment of high-grade recurrences."

It is estimated that early-stage bladder cancer recurs in only 10 to 15 percent of patients in the first year, and in more than half of patients over time.  However, approximately one-third of all cystoscopies – a procedure using a thin instrument equipped with a camera and light to look at the inside of the bladder – generate false positive results.

Genomic Health and its collaborators used the Company's next-generation sequencing (NGS) and polymerase chain reaction (PCR) based platforms and refined methodology to target tumor-specific differential DNA methylation and single nucleotide variations. In the study, researchers identified tumor-specific DNA markers in 94 percent of tissue samples and found a strong association between the same markers in urine. These findings are expected to enable accurate monitoring for cancer recurrence in the urine of early-stage bladder cancer patients.   

"Building on the positive results from our previous, exploratory whole genome sequencing, here, we narrowed down our analysis to specific bladder cancer-related genomic regions to enable both accurate and cost-efficient detection of bladder cancer from urine," said Ellen Beasley, Ph.D., senior vice president, Research and Development, Genomic Health. "By providing physicians with a non-invasive tool to accurately assess cancer recurrence, our goal is to improve patient monitoring and to optimize treatment."

These new results, combined with an upcoming presentation of more detailed proof-of-concept study results at the American Association for Cancer Research (AACR) Precision Medicine Meeting in June, demonstrate Genomic Health's continued progress toward developing non-invasive tests aimed at individualizing cancer treatment at every stage of the disease. The Company is on track to launch its first liquid biopsy test in 2016.

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, YouTube 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 value and benefits of urine-based monitoring of bladder cancer patients; the expectation that the test results could enable a urine-based test for monitoring bladder cancer recurrence in early-stage patients, and the potential benefits of such a test; and the company's belief that the study results demonstrate continued progress toward development of non-invasive tests for individualized treatment at various stages of disease. 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; the company's ability to develop and commercialize new tests, including tests based on liquid biopsy; 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; 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 March 31, 2015. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statement.

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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SOURCE Genomic Health, Inc.

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