REDWOOD CITY, Calif., Sept. 9, 2014 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced that results from nine studies of Oncotype DX® in prostate, breast and renal cancers will be presented at the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid, September 26 30. Included in the program is the first presentation of strongly positive results from an additional large independent clinical validation study of the Oncotype DX prostate cancer test, conducted in collaboration with the Center for Prostate Disease Research, Rockville, Md. This new study demonstrates the test’s ability to predict a rise in prostate-specific antigen (PSA) following surgery (biochemical recurrence) and reconfirms Oncotype DX as a predictor of adverse pathology from the biopsy, as previously demonstrated in a published validation study performed by the University of California, San Francisco (UCSF).
Collectively, data being presented at the conference showcase Genomic Health’s successful approach to understanding tumor biology across different cancer types and highlight the following:
- Additional clinical validation of the Oncotype DX prostate cancer test, demonstrating its ability to predict both actionable and long term clinical endpoints related to disease aggressiveness
- Further evidence of the practice-changing impact of the Oncotype DX test in breast cancer
- The consistent importance of assessing multiple, disease relevant, biological pathways to predict tumor behavior
Presentation details are as follows (all times are in Central European Time):
Prostate Cancer
Poster Discussion Session: “A prospectively-designed study to determine the association of a 17-gene genomic prostate score with recurrence following surgery for localized prostate cancer (PCa)” (Abstract #LBA22)
- Lead Author: J. Cullen, Rockville, United States of America
- Time: Sunday, September 28, 1 p.m. 2 p.m.
- Location: Granada
Breast Cancer
Poster Discussion Session: “The 12-gene DCIS Score Assay and Quantitative ER, PR, and HER2 Across Histologic Subtypes: Experience in the First 2 Years” (Abstract #259PD)
- Lead Author: A. Sing, Seattle, United States of America
- Time: Saturday, September 27, 12:45 p.m. 1:45 p.m.
- Location: Pamplona
Poster Discussion Session: “The effect of physician’s characteristics on adjuvant chemotherapy (CT) decisions for early stage HR+, HER2- breast cancer (BC) patients (pts)” (Abstract #261PD)
- Lead Author: M. De Laurentiis, Naples, Italy
- Time: Saturday, September 27, 12:45 p.m. 1:45 p.m.
- Location: Pamplona
Poster Display Session: “Prediction of recurrence with the Recurrence Score in pre- and post-menopausal patients from the PACS01 trial” (Abstract #174P)
- Lead Author: F. Penault-Llorca, Clermont-Ferrand, France
- Time: Sunday, September 28, 12:45 p.m. 1:45 p.m.
- Location: Poster Area
Poster Display Session: “Recurrence Score and Quantitative ER Expression Predicts Late Distant Recurrence Risk in ER+ BC after Five Years of Tamoxifen” (Abstract #177P)
- Lead Author: T. Mamounas, Orlando, United States of America
- Time: Sunday, September 28, 12:45 p.m. 1:45 p.m.
- Location: Poster Area
Poster Display Session: “A laboratory comparison of the 21-gene assay and PAM50-ROR” (Abstract #287P)
- Lead Author: M. Alvarado, San Francisco, United States of America
- Time: Monday, September 29, 12:45 p.m. 1:45 p.m.
- Location: Poster Area
Poster Display Session: “Impact of the 21-Gene Breast Cancer Assay on Treatment Recommendations for Estrogen Receptor-Positive (ER+) Early Stage Breast Cancer (ESBC) in Hong Kong” (Abstract #288P)
- Lead Author: R. Leung, Hong Kong
- Time: Monday, September 29, 12:45 p.m. 1:45 p.m.
- Location: Poster Area
Poster Display Session: “Traditional prognostic factors used for adjuvant chemotherapy (CT) decisions in early stage HR+, HER2 breast cancer in a large international survey (MAGIC) among breast cancer specialists” (Abstract #295P)
- Lead Author: M. Martin Jimenez, Madrid, Spain
- Time: Monday, September 29, 12:45 p.m. 1:45 p.m.
- Location: Poster Area
Renal Cancer
Poster Display Session: “Genomic renal score for assessing risk of recurrence in renal cancer: subgroup analyses from the validation study” (Abstract #814PD)
- Lead Author: B. Escudier, Villejuif, France
- Time: Monday, September 29, 1 p.m. 2 p.m.
- Location: Cordoba
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 screening and surveillance, through diagnosis, treatment selection and monitoring. Genomic Health’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, and the Oncotype DX prostate cancer test, which predicts disease aggressiveness in men with low risk disease. As of June 30, 2014, more than 19,000 physicians in over 70 countries had ordered more than 465,000 Oncotype DX tests. 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. To learn more about OncotypeDX tests, visit: www.OncotypeDX.com, www.mybreastcancertreatment.org and www.myprostatecancertreatment.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 attributes and focus of the company’s product pipeline; the applicability of clinical study results to actual outcomes; the ability of any potential tests the company may develop to optimize cancer treatment; and the ability of the company to develop and commercialize additional tests in the future. 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 June 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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SOURCE Genomic Health, Inc.
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