Key Developments: Genomic Health Inc (GHDX.O)
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21 May 2013
$0.03 (+0.08%)
$37.25
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$37.46
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226,683
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Latest Key Developments (Source: Significant Developments)
Genomic Health Inc Presents Twenty Two International Studies Demonstrating Worldwide Adoption And Value Of Oncotype DX Breast Cancer Test
Genomic Health Inc announced the presentation of results from 22 studies at the 13th St. Gallen International Breast Cancer Conference highlighting the impact of the Oncotype DX breast cancer test around the world. New data continue to demonstrate the test's ability to change treatment decisions and provide economic value across multiple health care systems, while reinforcing its clinical validation, accuracy and precision. This unparalleled number of studies and consistency of results emphasize the benefit that the OncotypeDX test provides in breast cancer as the only genomic test shown to predict chemotherapy benefit. A summary of clinical evidence for the Oncotype DX test involving 5,854 patients identified six unique prospectively-designed studies of archived samples that met the strict definition of clinical validation, reinforcing that the Oncotype DX test is the only genomic assay to meet level 1B evidence (Simon RM, Paik S, and Hayes DF. JNCI 2009) for clinical use in early-stage, hormone-receptor positive, invasive, breast cancer patients. Additionally, this analysis includes 11 supportive studies. Decision Impact Data from France, Germany, Israel, Spain, the United Kingdom and United Arabic Emirates Show Oncotype DX Changes Physician Treatment Recommendations. Full Article
Genomic Health Inc Issues FY 2013 Guidance In Line With Analysts' Estimates
Genomic Health Inc announced that for fiscal 2013, it expects total revenue in the range of $258-$266 million and GAAP basic net income (loss) per share between a net loss of ($0.12) and net income of $0.08. According to I/B/E/S Estimates, analysts on an average were expecting the Company to report revenues of $262 million and EPS of $0.04 for fiscal 2013. Full Article
NewBridge Pharmaceuticals Forms Partnership With Genomic Health Inc To Bring Novel Genomic Testing to Patients in Middle East, Africa, and Caspian Regions
NewBridge Pharmaceuticals announced that the Company has established an exclusive agreement with Genomic Health, Inc a global health company that provides actionable genomic information to personalize genomic health decisions, to provide the Oncotype DX(R) test in the NewBridge's core strategic territoriesin the Middle East, Africa, and Caspian regions. As part of this agreement, NewBridge will be able to offer the Oncotype DX tests for treatment of patients with early-stage, estrogen-positive (ER+) invasive breast cancer, DCIS (ductal carcinoma in situ of the breast), as well as colon cancer patients with stage II and stage III disease. Full Article
Genomic Health, Inc. Issues FY 2012 Revenue Guidance In Line With Analysts' Estimates; Issues FY 2012 Net Income Guidance
Genomic Health, Inc. announced that for fiscal 2012, it expects total revenue of $230 to $240 million and net income of $5 to $8 million before an incremental loss of approximately $1 million in InVitae. According to I/B/E/S Estimates, analysts on an average were expecting the Company to report revenues of $234 million for fiscal 2012. Full Article
Genomic Health, Inc. Announces Results Of Oncotype DX Breast Cancer Test Treatment Decision-Impact Study
Genomic Health, Inc. announced the results of the first Oncotype DX breast cancer test treatment decision-impact study from Canada, recently presented at the American Society of Clinical Oncology (ASCO) 2012 Annual Meeting. 150 invasive, estrogen-receptor positive, node-negative early-stage breast cancer patients and their physicians were surveyed prior to using the Oncotype DX test regarding their treatment preferences and their level of confidence about the treatment. After patients and physicians received the Oncotype DX Recurrence Score results, the following was found knowledge of the Recurrence Score result changed physicians' treatment recommendation for 30% of invasive early-stage breast cancer patients; this change includes 20% of patients who were advised to omit chemotherapy and use only hormonal therapy; importantly, an additional 10% of patients were advised to add chemotherapy as they would benefit from the treatment based on the biology of their individual tumour. Full Article
Genomic Health, Inc. Announces Formation Of New Genetics Subsidiary
Genomic Health, Inc. announced the plans to establish a wholly owned subsidiary with the goal of improving the diagnosis, communication and support for millions of patients and their families faced with common and rare genetic conditions. The subsidiary is expected to be established by March 1, 2012 and provide its first commercial service in 2013. The new venture will be led by Randy Scott, who in his role as Executive Chairman for the past three years has focused on commercial applications of next generation sequencing. Dr. Scott will be CEO of the new subsidiary and remain a Genomic Health Board member and Kim Popovits, President and Chief Executive Officer, will assume the additional role of Chairman of the Board effective March 1, 2012. In a related action, Julian Baker has been named as Lead Independent Director. Full Article
Genomic Health, Inc. Issues FY 2012 Guidance; Revenue Guidance In Line With Analysts' Estimates
Genomic Health, Inc. announced that for fiscal 2012, it expects revenues of $230 to $240 million and net income to be between $5-$8 million before an incremental loss of up to $8 million in new subsidiary. According to I/B/E/S Estimates, analysts on an average were expecting the Company to report revenues of $236 million for fiscal 2012. Full Article
Genomic Health, Inc. Presents Results From First Clinical Decision Making Study of Oncotype DX Colon Cancer
Genomic Health, Inc. announced positive results of the first clinical decision making study of the Oncotype DX colon cancer test that shows that Recurrence Score (RS) result has a significant impact on treatment recommendations for stage II colon cancer patients. The data demonstrate that knowledge of a patient's Recurrence Score changes medical oncologists' treatment recommendations in 29% of cases, further confirming the clinical utility of using Oncotype DX as an independent predictor of recurrence in stage II colon cancer. These results are also consistent with the change rate of approximately 30% that has been observed in studies evaluating the impact of the Oncotype DX breast cancer test on treatment decisions in early-stage breast cancer patients. To characterize the impact of the Oncotype DX test on adjuvant treatment recommendations in stage II colon cancer, U.S. medical oncologists who had used the test on three or more patients participated in a survey to assess how the Recurrence Score impacted their treatment decisions. Out of the 92 patients who had treatment recommendations before having Oncotype DX testing, physicians changed treatment recommendations based on the Recurrence Score results in 27 patients (29%). Two-thirds (67%) of changes in treatment recommendations were decreases in treatment intensity (changes from chemotherapy to observation or from oxaliplatin-containing chemotherapy to treatment with fluoropyrimidine monotherapy). Full Article
Genomic Health, Inc. Announces Initiation of Clinical Validation Study of Prostate Cancer Test; Acceleration of Next Generation Sequencing Program
Genomic Health, Inc. announced that it has started a large clinical validation study of its prostate cancer test. The study, being performed in collaboration with prostate cancer researchers at the University of California, San Francisco (UCSF), is designed to determine if a multi gene test can help distinguish aggressive disease requiring surgery from less aggressive disease that may undergo active surveillance in patients with early stage prostate cancer. The study will utilize Genomic Health's RT-PCR process for analyzing very small amounts of formalin-fixed paraffin-embedded (FFPE) prostate tissue obtained by needle biopsy prior to removal of the prostate. Complete results are expected to be presented at the end of this year or early next year, and if positive, are expected to support the launch of the Oncotype DX prostate cancer test in 2013. Full Article
Genomic Health, Inc. Announces Results From 14 Studies Emphasizing Belief of Physicians Around The World In The Value Of Oncotype DX
Genomic Health, Inc. announced the presentation of results from fourteen studies at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) reinforcing the impact of the Oncotype DX breast cancer test on changing treatment decisions and demonstrating its cost effectiveness across multiple health care systems. Additionally, data continues to reconfirm the accuracy, precision, reproducibility and consistency of the Recurrence Score (RS) results in patients with early-stage breast cancer. Presentations included ten international studies from the United Kingdom, Germany, France, Ireland, Australia, Venezuela, and a review including data from Israel, Canada, Hungary, Japan, and Singapore. Results based on decision impact studies that include a total of 658 patients from the United Kingdom, Germany, and Australia confirm data from previous similar studies reinforcing that knowledge of a patient's Recurrence Score changes about 30 percent of adjuvant chemotherapy treatment decisions. Furthermore, data indicate that the Oncotype DX RS result has a similar impact on treatment decision making in node-positive patients as it does in node-negative patients Full Article
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