Genomic Health Announces Presentation of Sixteen Oncotype DX Studies at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium

Oncotype DX DCIS Results to be Highlighted in SABCS Press Briefing on December 7, 7:30 AM CST-

REDWOOD CITY, Calif., Nov. 29, 2011 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced that the company will present results from sixteen studies at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium (SABCS), taking place December 6-10, 2011 at the Henry B. Gonzalez Convention Center.  The SABCS press briefing on Wednesday, December 7 at 7:30 AM Central Time, will include the findings of the DCIS study. 

Presentations include:

•Oral presentation of the complete results from a study of Oncotype DX® in patients with DCIS (ductal carcinoma in situ of the breast) conducted by the Eastern Cooperative Oncology Group (ECOG)
•The first clinical outcomes study for biomarker discovery using next generation sequencing (NGS) technology in fixed paraffin embedded tissue
•Multiple international studies on the impact of Oncotype DX on changing treatment decisions and/or the test's cost effectiveness in the United Kingdom, Germany, France, Ireland, Israel, Canada, Hungary, Japan, Singapore, Australia, and Venezuela
 

Following are details for each embargoed session (all times are in Central Standard Time), including the DCIS oral presentation on Thursday, December 8 at 4:30 PM, and NGS poster discussion on Thursday, December 8 at 7:30 AM.

Wednesday, December 7, 2011

>
 Abstract: P1-07-11
 
 
 Poster Session 1 (Tumor Cell Biology: Immunology and Preclinical Immunotherapy):  "Consistency and Control in Clinical Assay Technology over Time: The Oncotype DX Recurrence Score and Assessment of Single Gene Expression Levels"
 
 
 Lead Author: F. Baehner, M.D., Genomic Health
 
 
 Location: Exhibit Halls A-B
 
 
 Time: 5:00 p.m. – 7:00 p.m.
 
 
 
 
>
 Abstract: P1-07-22
 
 
 Poster Session 1 (Tumor Cell Biology: Immunology and Preclinical Immunotherapy):  "A Venezuelan Study of Breast Cancer Estrogen Receptor, Progesterone Receptor and HER2 Receptor Expression by the Standard Method, Immunohistochemistry (IHC), Compared to a New Method, Quantitative Reverse Transcription Polymerase Chain Reaction (RT-PCR)"
 
 
 Lead Author: Marin C-EM, M.D.
 
 
 Location: Exhibit Halls A-B
 
 
 Time: 5:00 p.m. – 7:00 p.m.
 
 
 
 
>
 Abstract: P1-10-04
 
 
 Poster Session 1 (Tumor Cell Biology: Immunology and Preclinical Immunotherapy):  "Cost-Utility of the 21-Gene Breast Cancer Assay (Oncotype DX) in the Irish Healthcare Setting"
 
 
 Lead Author: L. Lacey, M.D.
 
 
 Location: Exhibit Halls A-B
 
 
 Time: 5:00 p.m. – 7:00 p.m.
 
 
 
 
>
 Abstract: P1-10-05
 
 
 Poster Session 1 (Tumor Cell Biology: Immunology and Preclinical Immunotherapy):  "Is the 21-Gene Breast Cancer Test (Oncotype DX) Cost-Effective?"
 
 
 Lead Author: P. Pronzato, M.D.
 
 
 Location: Exhibit Halls A-B
 
 
 Time: 5:00 p.m. – 7:00 p.m.
 
 
 
 
>
 Abstract: P1-10-06
 
 
 Poster Session 1 (Tumor Cell Biology: Immunology and Preclinical Immunotherapy):  "Economic Analysis of Chemotherapy Costs for Adjuvant Therapy in Breast Cancer in France"
 
 
 Lead Author: E. Chereau, M.D.
 
 
 Location: Exhibit Halls A-B
 
 
 Time: 5:00 p.m. – 7:00 p.m.
 
Thursday, December 8, 2011

>
 Abstract: PD03-09
 
 
 Poster Discussion III (Genomics): "Breast Cancer Recurrence Risk Probed by Whole Transcriptome Next Generation Sequencing in 136 Patients"
 
 
 Lead Author: J. Baker, Genomic Health
 
 
 Location: Ballroom A
 
 
 Time: Viewing – 7:00 a.m. – 9:00 a.m.; Discussion – 7:45 a.m.
 
 
 
 
>
 Abstract: P2-12-26
 
 
 Poster Session 2 (Tumor Cell Biology: Tumor Progression, Invasion, and Metastasis): "Impact of the Recurrence Score on Adjuvant Decision-Making in ER-Positive Early Breast Cancer - Results of a Large Prospective Multicenter Decision Impact Study in Node Negative and Node Positive Disease"
 
 
 Lead Author: M. Rezai, M.D.
 
 
 Location: Exhibit Halls A-B
 
 
 Time: 7:00 a.m. – 9:00 a.m.
 
 
 
 
>
 Abstract: S4-3
 
 
 General Session 4: "Prospective comparison of risk assessment tools in early breast cancer (recurrence score, uPA/PAI-1, central grade, and luminal subtypes): Final correlation analysis from the phase III WSG-Plan B trial"
 
 
 Lead Author: O. Gluz, M.D.
 
 
 Location: Exhibit Hall D
 
 
 Time: 3:45 p.m.
 
 
 
 
>
 Abstract: S4-6
 
 
 General Session 4: "A quantitative multigene RT-PCR assay for predicting recurrence risk after surgical excision alone without irradiation for ductal carcinoma in situ (DCIS): A prospective validation study of the DCIS score from ECOG E5194"
 
 
 Lead Author: L. Solin, M.D.
 
 
 Location: Exhibit Hall D
 
 
 Time: 4:30 p.m.
 
 
 
 
>
 Abstract: PD06-02
 
 
 Poster Discussion VI (Cost Effectiveness/Utilization): "Cost-Effectiveness Evaluation of the Oncotype DX Breast Cancer Assay in Clinical Practice in the UK"
 
 
 Lead Author: C. Phillips, M.D.
 
 
 Location: Ballroom B
 
 
 Time: Viewing - 5:15 p.m. – 7:00 p.m.; Discussion - 5:30 p.m.
 
 
 
 
>
 Abstract: P3-06-05
 
 
 Poster Session 3 (Tumor Cell Biology: Novel/Emerging Therapeutic Targets): "Comparison of Oncotype DX Recurrence Scores between Surgical and Core Biopsy Specimens in Breast Cancer Patients"
 
 
 Lead Author: T.S. Stull, M.D.
 
 
 Location: Exhibit Halls A-B
 
 
 Time: 5:00 p.m. – 7:00 p.m.
 
Friday, December 9, 2011

>
 Abstract: P4-09-18
 
 
 Poster Session 4 (Tumor Cell Biology: Endocrine Therapy and Resistance18): "Australian Decision Impact Study: The Impact of Oncotype DX Recurrence Score (RS) on Adjuvant Treatment Decisions in Hormone Receptor Positive (HR+), Node Negative (N0) and Node Positive (N+) Early Stage Breast Cancer (ESBC) in the Multidisciplinary Clinic (MDC)"
 
 
 Lead Author: R.H. de Boerv
 
 
 Location: Exhibit Halls A-B
 
 
 Time: 7:00 a.m. – 9:00 a.m.
 
 
 
 
>
 Abstract: P5-13-09
 
 
 Poster Session 5 (Tumor Cell Biology: Biomarkers): "Correlation of Oncotype DX Recurrence Scores with Pathologic Response Following Neoadjuvant Ixabepilone and Cyclophosphamide in Patients with HER2-Negative Breast Cancer: A Sarah Cannon Research Institute Phase II Trial"
 
 
 Lead Author: D. Yardley, M.D.
 
 
 Location: Exhibit Halls A-B
 
 
 Time: 5:00 p.m. – 7:00 p.m.
 
 
 
 
>
 Abstract: P5-14-03
 
 
 Poster Session 5 (Tumor Cell Biology: Biomarkers): "Genomic Comparison of Paired Primary Breast Carcinomas and Macrometastatic Lymph Node Metastases Using Quantitative RT-PCR by Oncotype DX: Assessment of the Recurrence Score and Quantitative Single Genes"
 
 
 Lead Author: S. Boolbol, M.D.
 
 
 Location: Exhibit Halls A-B
 
 
 Time: 5:00 p.m. – 7:00 p.m.
 
 
 
 
>
 Abstract: P5-14-26
 
 
 Poster Session 5 (Tumor Cell Biology: Biomarkers): "Results from a Prospective Clinical Study on the Impact of Oncotype DX on Adjuvant Treatment Decision Making in a Cohort of 142 UK Patients"
 
 
 Lead Author: S. Holt, M.D.
 
 
 Location: Exhibit Halls A-B
 
 
 Time: 5:00 p.m. – 7:00 p.m.
 
 
 
 
>
 Abstract: P5-18-03
 
 
 Poster Session 5 (Tumor Cell Biology: Biomarkers): "First Interim Toxicity Analysis of the Randomized Phase III WSG Plan B Trial Comparing 4xEC-4xDoc Versus 6xTC in Breast Cancer Patients with HER2 Negative Breast Cancer (BC)"
 
 
 Lead Author: U. Nitz, M.D.
 
 
 Location: Exhibit Halls A-B
 
 
 Time: 5:00 p.m. – 7:00 p.m.
 
 

About Genomic Health and the Oncotype DX® Tests

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 to help optimize treatment options. Oncotype DX is the only test incorporated in published ASCO® and NCCN® breast cancer treatment guidelines for patients with node-negative breast cancer that is estrogen-receptor positive and/or progesterone-receptor positive.[1]  The test is also recognized in international guidelines issued by St. Gallen International Breast Cancer Expert Panel and European Society for Medical Oncology (ESMO).

Physicians also use the Oncotype DX Breast Cancer test to make treatment recommendations for certain node-positive breast cancer patients. 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.

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. Genomic Health collaborated with the National Surgical Adjuvant Breast and Bowel Project and Cleveland Clinic on a total of four development studies in more than 1,800 to analyze patients with stage II colon cancer.  The final gene panel was then independently evaluated in more than 1,400 stage II colon cancer patients in the QUASAR validation study.

As of September 30, 2011, more than 10,000 physicians in over 60 countries had ordered more than 230,000 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.  To learn more about Oncotype DX tests, visit: www.oncotypedx.com and www.mybreastcancertreatment.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 ability of the company to develop additional tests in the future, the impact of clinical studies on the use of the company's tests, and the ability of any potential tests the company may develop to optimize cancer treatment. 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; unanticipated costs or delays in research and development efforts; our 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 period ended September 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.

[1] ASCO and NCCN are registered trademarks of the American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN), respectively.  ASCO and NCCN do not endorse any product or therapy.

 

 

 


SOURCE Genomic Health, Inc.


 

Posted: November 2011

View comments

Hide
(web3)