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Genomic Health Announces Ten Studies Covering Breast, Colon and Prostate Cancers Accepted for Presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting

May 18, 2011

REDWOOD CITY, Calif., May 18, 2011 /PRNewswire/ — Genomic Health, Inc. (Nasdaq: GHDX) today announced that the company will present results from ten separate studies at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 3-7, 2011 at McCormick Place in Chicago. The company markets the widely-adopted Oncotype DX® breast cancer test, which is clinically validated to predict chemotherapy benefit as well as the likelihood of recurrence in early-stage breast cancer patients and the Oncotype DX colon cancer test, the first multigene expression test developed for the assessment of risk of recurrence in patients with stage II disease. Genomic Health is also developing a test for prostate cancer based on positive gene identification study results presented earlier this year, with the goal of making a test available to patients in 2013.

The majority of ASCO Annual Meeting abstracts are now publicly available on ASCO’s website, www.asco.org.

Presentation details are as follows (all times are in Central Time):

Breast Cancer

Saturday, June 4, 2011

Poster Presentation: “A cost benefit analysis of the 21-gene breast cancer assay within a Canadian health care system” (Abstract #6111)

  • Lead Author: Shazia Hassan, Sunnybrook Health Sciences Centre, Toronto, Canada
  • Presentation Time: 8:00 AM – 12:00 PM
  • Location: Hall A
  • Poster Board: #49C

Monday, June 6, 2011

Poster Presentation: “Prospective comparison of recurrence score, uPA/PAI-1, central grade and molecular classification in early breast cancer: Interim results from the WSG-Plan B trial” (Abstract #10594)

  • Lead Author: Tom Degenhardt, On behalf of the Plan B Investigators, West German Study Group
  • Session Time: 8:00 AM – 12:00 PM
  • Location: Hall A
  • Poster Board: #31C

Poster Presentation: “A study of the recurrence score by the 21-gene signature assay as a predictor of clinical response to neoadjuvant exemestane for 24 weeks in estrogen-receptor- positive breast cancer” (Abstract #558)

  • Lead Author: Norikazu Masuda, National Hospital Organization, Osaka National Hospital, Osaka, Japan
  • Presentation Time: 1:00 PM – 5:00 PM
  • Location: Hall A
  • Poster Board: #3H

Poster Presentation: “Using the 21-gene Recurrence Score (RS) and the recently developed Recurrence Score-Pathology-Clinical (RSPC) to assess recurrence risk in patients with node-negative, ER-positive early-stage breast cancer receiving aromatase inhibitor treatment alone” (Abstract #592)

  • Lead Author: Michael Crager, Genomic Health, Inc., Redwood City, California
  • Session Time: 1:00 PM – 5:00 PM
  • Location: Hall A
  • Poster Board: #8B

Poster Presentation: “Evaluating utilization characteristics for the Oncotype DX recurrence score in early-stage breast cancer” (Abstract #625)

  • Lead Author: Clara Chen, U.S. Oncology Network, The Woodlands, Texas
  • Session Time: 1:00 PM – 5:00 PM
  • Location: Hall A
  • Poster Board: #12C

Poster Presentation: “Evaluation of recurrence score and traditional clinicopathologic assessments in a large ER-positive, lymph node-negative patient cohort” (Abstract #632)

  • Lead Author: Nancy Liebermann, Clalit Health Services, Tel Aviv, Israel
  • Session Time: 1:00 PM – 5:00 PM
  • Location: Hall A
  • Poster Board: #13B

Poster Presentation: “Ixabepilone and cyclophosphamide as neoadjuvant therapy in HER2-negative breast cancer with exploratory Oncotype DX assessments: A Sarah Cannon Research Institute phase II trial” (Abstract #1066)

  • Lead Author: Nancy W. Peacock, Sarah Cannon Research Institute and Tennessee Oncology, Nashville, Tennessee
  • Session Time: 1:00 PM – 5:00 PM
  • Location: Hall A
  • Poster Board: #17G

Colon Cancer

Monday, June 6, 2011

Poster Discussion: “Validation of a 12-gene colon cancer recurrence score (RS) in patients (pts) with stage II colon cancer (CC) from CALGB 9581″ (Abstract #3518)

  • Presenter: Alan P. Venook University of California, San Francisco, San Francisco, California
  • Session Time and Location: 8:00 AM – 12:00 PM, E450B
  • Discussion Time and Location: 11:45 AM – 12:00 PM, Hall D1
  • Poster Board: #7

Prostate Cancer

Saturday, June 4, 2011

Poster Discussion: “Use of TMPRSS2-ERG gene rearrangement and quantitative ERG expression to predict clinical recurrence after radical prostatectomy” (Abstract #4541)

  • Presenter: Sara M. Falzarano Cleveland Clinic Pathology and Laboratory Medicine Institute, Cleveland, Ohio
  • Session Time and Location: 2:00 PM – 6:00 PM, E450A
  • Discussion Time and Location: 5:45 PM – 6:00 PM, Hall D2
  • Poster Board: #21

Sunday, June 5, 2011

Poster Presentation: “Quantitative gene expression in primary and highest Gleason pattern cancer specimens identifies genes associated with clinical recurrence and prostate cancer-specific survival after radical prostatectomy” (Abstract #4663)

  • Lead Author: Eric A. Klein, Cleveland Clinic Glickman Urological and Kidney Institute, Cleveland, Ohio
  • Session Time: 8:00 AM – 12:00 PM
  • Location: Hall A
  • Poster Board: #12G

About the Oncotype DX® Breast Cancer Test*

The Oncotype DX breast cancer test is a multigene expression test that examines a breast cancer patient’s tumor tissue at a molecular level, and gives information about their individual disease to help optimize treatment options. Oncotype DX is the only test incorporated in published ASCO® and NCCN® breast cancer treatment guidelines to predict the likelihood of chemotherapy benefit as well as recurrence for patients with node-negative breast cancer that is estrogen-receptor positive and/or progesterone-receptor positive.

Additionally, physicians use Oncotype DX to make treatment recommendations for certain node-positive breast cancer patients, and the test report also provides quantitative scores for select individual genes. 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. Both Medicare and private health plans covering over 95 percent of U.S. insured lives provide reimbursement for Oncotype DX for patients with node-negative breast cancer that is estrogen-receptor positive and/or progesterone-receptor positive through contracts, agreements or policy decisions. For more information about Oncotype DX for breast cancer, please visit www.oncotypedx.com or www.untileverywomanknows.com.

*ASCO® is a registered trademark of the American Society of Clinical Oncology. NCCN® is a registered trademark of the National Comprehensive Cancer Network. ASCO and NCCN do not endorse any product or therapy.

About Oncotype DX® Colon Cancer Test

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. For its colon cancer program, Genomic Health and its collaborators used the same rigorous clinical development strategy and standardized quantitative technology designed for the company’s Oncotype DX Breast Cancer test. National Surgical Adjuvant Breast and Bowel Project (NSABP) conducted three development studies and Cleveland Clinic conducted one development study, all of which were funded by Genomic Health, analyzing 761 genes from 1,851 patients with stage II colon cancer. The final set of seven recurrence and five reference genes were then independently evaluated in 1,436 stage II colon cancer patients in the QUASAR validation study. For more information about Oncotype DX for colon cancer, please visit www.oncotypedx.com.

About Genomic Health

Genomic Health, Inc. (NASDAQ: GHDX) is a molecular diagnostics company focused on the global development and commercialization of genomic-based clinical laboratory services that analyze the underlying biology of cancer allowing physicians and patients 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. In addition to this widely adopted test, Genomic Health provides the Oncotype DX colon cancer test, the first multigene expression test developed for the assessment of risk of recurrence in patients with stage II disease. As of March 31, 2011, more than 10,000 physicians in over 60 countries had ordered more than 200,000 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.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to our ability to generate similar results in further studies, the clinical utility of preliminary biomarkers; our ability to develop and launch a test for prostate cancer in 2013 the ability of the company to develop additional tests in the future; the ability of any tests the company may develop to optimize cancer treatment; the scope, success or results of clinical trials and the timing of such activities; the applicability of clinical study results to actual outcomes; and 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 risks and uncertainties associated with the regulation of our tests; the risks associated with competition; the applicability of clinical study results to actual outcomes; the risks associated with the commercialization of current and future products; the risks and potential delays associated with such studies; 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 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.

SOURCE Genomic Health, Inc.


Source: newswire



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