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genomic health inc (GHDX) Key Developments

Genomic Health, Inc. Announces Management Changes

On June 13, 2014, Dean L. Schorno, Chief Financial Officer of Genomic Health Inc. notified the company that he would be resigning from his position to pursue a chief financial officer opportunity with a privately held company. Mr. Schorno will remain available for consultation during a transition period. The company's Board of Directors has appointed G. Bradley Cole, the company's Chief Operating Officer, to serve in the additional positions of Chief Financial Officer and principal financial and accounting officer effective June 19, 2014. Mr. Cole, age 58, has served as the company's Chief Operating Officer since January 2009, and also served as the company's Chief Financial Officer from July 2004 until January 2011. The company intends to conduct a search for a new Chief Financial Officer.

Genomic Health Announces Positive Topline Results of Second Large, Independent Validation Study of Oncotype DX(R) in DCIS Breast Cancer

Genomic Health Inc. announced positive preliminary results from a second large, independent clinical validation study of Oncotype DX(R) in patients with a pre-invasive form of breast cancer, also known as DCIS (ductal carcinoma in situ). The study, conducted by the Ontario DCIS Study Group in Canada, met its primary endpoint by demonstrating that the Oncotype DX DCIS Score(TM) predicts the risk of local recurrence, defined as either the development of a new invasive breast cancer or the recurrence of DCIS in the same breast. Representing the genomic study in DCIS to date, these results confirm and extend the conclusions of the previously published validation study performed by the ECOG-ACRIN Cancer Research Group. Additionally, for the first time, the Oncotype DX DCIS Score predicted the risk of local recurrence in a group of patients treated with radiation therapy in clinical practice. Genomic Health and the Ontario DCIS Study Group are submitting the results from this study for presentation at the 2014 San Antonio Breast Cancer Symposium in December. Genomic Health researchers collaborated with the Ontario DCIS Study Group to examine a population-based cohort of more than 1,200 DCIS patient tumor samples collected from patients diagnosed with DCIS between 1994 and 2003, including both patients treated with surgery alone and patients treated with surgery plus radiation. DCIS -- an early, non-invasive form of breast cancer, considered stage zero, in which the tumor cells are confined within the milk ducts in the breast -- affects one out of every five women diagnosed with breast cancer in the U.S. Most women with DCIS who receive breast-conserving surgery without standard radiotherapy will not develop a local recurrence. However, an estimated 80% of these women currently receive additional treatments that may not be necessary, while other women may not appropriately receive more aggressive treatment resulting in the development of cancers that might have been preventable with treatment. To help a woman and her doctor make a more informed decision about her DCIS treatment, Genomic Health developed the Oncotype DX DCIS Score to provide more precise information about her individual risk of a recurrence of either DCIS or invasive breast cancer by looking at 12 genes within a tumor sample to reveal the aggressiveness of the disease. A clinical decision impact study recently presented at ASCO(R) demonstrated that the Oncotype DX DCIS Score results changed treatment recommendations for one out of three patients with DCIS, highlighting the need for optimizing treatment of this non-invasive form of breast disease.

Genomic Health Demonstrates the Importance of Utilizing Multiple Biological Pathways to Predict Tumor Behavior in Prostate and Renal Cancers

Genomic Health Inc. announced results of two studies demonstrating the ability of its Oncotype DX(R) test and a new 16-gene panel to predict disease aggressiveness and clinical outcomes in prostate and renal cancers, respectively. These results, presented at the American Society of Clinical Oncology(R) (ASCO(R)) Annual Meeting in Chicago, underscore the company's successful approach to understanding tumor biology, resulting in tests that incorporate distinct genes across multiple pathways to provide more precise risk assessment than currently available risk factors and help improve treatment decision making. In the prostate cancer study, researchers at the University of California, San Francisco (UCSF) conducted an analysis of 395 patient samples to evaluate the ability of the Oncotype DX Genomic Prostate Score (GPS) to predict cancer aggressiveness despite variability in pathology assessment. The analysis revealed that original pathology readings of tumor grade and stage, rendered by more than 15 pathologists, frequently differed from the central review that was performed by a single expert urologic pathologist as part of the clinical validation study. For both biopsy and radical prostatectomy specimen evaluation, the pathology results for Gleason Score were different in one out of every four patients (24% and 26%, respectively). Despite these discordances, GPS remained a robust predictor of adverse pathology at surgery.

Genomic Health Inc. Presents at Jefferies 2014 Global Healthcare Conference, Jun-02-2014 04:00 PM

Genomic Health Inc. Presents at Jefferies 2014 Global Healthcare Conference, Jun-02-2014 04:00 PM. Venue: Grand Hyatt, New York, New York, United States. Speakers: Brad Cole, COO, Emily Faucette, VP, Corp Comm & IR.

Genomic Health Announces Data Reinforcing Robustness of Oncotype DX Prostate Cancer Test at 2014 American Urological Association Annual Meeting

Genomic Health Inc. presented positive results reinforcing the robustness of the Oncotype DX(R) prostate cancer test's development as a predictor of prostate cancer aggressiveness. A sub-analysis of a large Oncotype DX Genomic Prostate Score (GPS) development study, presented at the American Urological Association (AUA) Annual Meeting on May 20 in Orlando, suggests that GPS predicts time to clinical progression regardless of the treatment received following surgery. This exploratory analysis from one of the original development studies looked at a subset of 185 prostate cancer patients who experienced biochemical recurrence after surgery. These patients were analyzed in three subgroups based on treatment received at time of biochemical recurrence: men who did not receive additional treatment, men who received hormonal therapy and men who received radiation therapy. Results showed that the Oncotype DX Genomic Prostate Score was predictive of clinical recurrence for all patients, regardless of the type of treatment patients received. For each therapy subgroup, different biological pathways within the GPS were most highly associated with patient outcome. As Genomic Health expands its focus on furthering understanding of prostate cancer biology, the company will continue to explore potential future applications of Oncotype DX to predict specific therapy benefit.


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