Genomic Health, Inc.
Jun 16, 2015
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Genomic Health Presents Positive Proof-of-Concept Data for Bladder Cancer Liquid Biopsy Test

Results Presented at AACR Demonstrate Company's Ability to Monitor Bladder Cancer Using Non-Invasive Urine Test with Accuracy Comparable to Cystoscopy

REDWOOD CITY, Calif., June 16, 2015 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced positive results from a liquid biopsy proof-of-concept study demonstrating its ability to more conveniently detect disease recurrence with a level of accuracy comparable to cystoscopy, an invasive procedure for surveillance of early-stage bladder cancer. These results support Genomic Health's development of a urine test that may offer physicians and patients a non-invasive alternative for physicians to monitor patients' bladder cancer.

"A liquid biopsy test has the potential to improve patient compliance during a surveillance protocol while monitoring for bladder cancer recurrence for patients with non-muscle invasive disease," said Neal Shore, M.D., medical director, Carolina Urologic Research Center. "This study contributes to the development of a urine test to optimize successful surveillance strategies and enhance the efficiency of care for bladder cancer patients." 

Early-stage bladder cancer is estimated to recur in 10 to 15 percent of patients in the first year and in more than half of patients over time. Currently, bladder cancer surveillance is repeated at frequent intervals via a cystoscopy, a procedure that inserts an instrument equipped with a camera and light to look at the inside of the bladder.

By measuring multiple target tumor-specific biomarkers using Genomic Health's liquid biopsy platform, the study demonstrated a negative predictive value for high-risk recurrence at that time of 95 percent, which means that if a patient's results are negative, there is a 95 percent chance that he or she has not had a recurrence at that time. These new results suggest that use of this urine-based liquid biopsy test would be expected to optimize surveillance and reduce the number of invasive procedures.

"This study represents one of many efforts in our robust research and development program to deliver multiple liquid-based tests for various tumor types beginning in 2016," said Ellen Beasley, Ph.D., senior vice president, Research and Development, Genomic Health. "As we continue to advance our liquid biopsy pipeline, we are moving forward with finalizing the development of a non-invasive, urine-based bladder cancer tracking test with a goal of initiating clinical validation later this year." 

The study, presented at the American Association for Cancer Research (AACR) Precision Medicine Meeting, included data from 74 patients across 14 sites, and was co-led by Associated Medical Professionals of New York, Carolina Urologic Research Center, Genomic Health, NorthShore University HealthSystem and Vanderbilt University Medical Center.

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: @GenomicHealthFacebookYouTube 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 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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SOURCE Genomic Health, Inc.

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