Key Developments: Genomic Health Inc (GHDX.O)

GHDX.O on Nasdaq

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24 Jul 2014
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Latest Key Developments (Source: Significant Developments)

Genomic Health announces positive topline results of second large, independent validation study of Oncotype DX in DCIS Breast Cancer
Wednesday, 11 Jun 2014 08:00am EDT 

Genomic Health Inc:Says positive preliminary results from a second large, independent clinical validation study of Oncotype DX in patients with a pre-invasive form of breast cancer, also known as DCIS (ductal carcinoma in situ).The study met its primary endpoint by demonstrating that Oncotype DX DCIS Score predicts risk of local recurrence, defined as either the development of a new invasive breast cancer or recurrence of DCIS in same breast.  Full Article

Genomic Health says oncotype DX breast cancer test predicts late recurrence five to 15 years out
Thursday, 29 May 2014 08:01am EDT 

Genomic Health Inc:Says positive study that confirmed that the Oncotype DX test results for Recurrence Score and quantitative estrogen-receptor predict late distant recurrence risk in early-stage breast cancer patients after initial tamoxifen therapy.Suggesting that Oncotype DX may help identify which patients have greater potential to benefit from extended hormonal treatment beyond five years.  Full Article

Genomic Health Inc gives FY 2020 guidance-Conference Call
Tuesday, 6 May 2014 04:30pm EDT 

Genomic Health Inc:Plans to deliver $1 billion revenue in FY 2020.  Full Article

Genomic Health Inc issues FY 2014 guidance below analysts' estimates
Tuesday, 4 Feb 2014 04:01pm EST 

Genomic Health Inc:Expects FY 2014 total revenue to be in the range of $278-$286 mln.Expects FY 2014 basic net loss between $0.95 per share and $0.75 per share.FY 2014 revenue of $295 mln and EPS of $0.21 -Thomson Reuters I/B/E/S.  Full Article

Genomic Health Inc announces presentation of new Oncotype DX studies underscoring value of the test in early-stage breast cancer
Saturday, 14 Dec 2013 08:35am EST 

Genomic Health Inc:Says results from three studies of its Oncotype DX breast cancer test presented at the 36th Annual CTRC-AACR San Antonio Breast Cancer Symposium (SABCS), reinforcing the unmatched value of the test to patients and physicians worldwide.Says Oncotype DX remains the only genomic test to predict chemotherapy benefit, delivering clinically important and practice-changing information not provided by any other test.Says a study examining three commercially available genomic tests evaluated if the information they provide is equivalent.Says specifically, results revealed a more than 44 pct discordance with other assays studied when compared to Oncotype DX, highlighting the potential to misclassify and mistreat patients if other assays are used to make a decision regarding chemotherapy treatment.Says Oncotype DX is the only test included in treatment guidelines for both prognosis and the prediction of chemotherapy benefit and widely reimbursed by public and private payors for treatment decision making.  Full Article

Genomic Health Inc Reaffirms FY 2013 Guidance - Conference Call
Tuesday, 5 Nov 2013 04:30pm EST 

Genomic Health Inc announced that fiscal 2013 guidance range for revenue and income remains unchanged. According to I/B/E/S Estimates, analysts on an average were expecting the Company to report revenues of $261 million and EPS of $(0.12) for fiscal 2013.  Full Article

Genomic Health Inc Presents Twenty Two International Studies Demonstrating Worldwide Adoption And Value Of Oncotype DX Breast Cancer Test
Friday, 15 Mar 2013 08:00am EDT 

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
Wednesday, 6 Feb 2013 04:01pm EST 

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
Monday, 13 Aug 2012 08:45am EDT 

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
Wednesday, 8 Aug 2012 04:00pm EDT 

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

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