Key Developments: Genomic Health Inc (GHDX.O)

GHDX.O on Nasdaq

2 Sep 2014
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Latest Key Developments (Source: Significant Developments)

Genomic Health, Inc updates FY 2014 revenue guidance - Conference Call
Wednesday, 13 Aug 2014 10:30am EDT 

Genomic Health, Inc:Expects FY 2014 guidance for revenues to be in the $280 some million range again.FY 2014 revenue of $282 million - Thomson Reuters I/B/E/S.  Full Article

Genomic Health Inc gives Q3 2014 guidance - Conference call
Thursday, 7 Aug 2014 04:30pm EDT 

Genomic Health Inc:Expects Q3 2014 revenues to be similar to Q2 2014 levels and net loss to be greater than Q2 2014.Reported revenue of $70.48 mln and net loss $4.62 mln in Q2 2014.  Full Article

Genomic Health Inc announces positive topline results of additional, large independent validation study of Oncotype DX Prostate cancer test with multiple clinical endpoints
Wednesday, 6 Aug 2014 08:00am EDT 

Genomic Health Inc:Announced positive preliminary results from an additional independent clinical validation study conducted by Center for Prostate Disease Research (CPDR).Study demonstrating that Oncotype DX Genomic Prostate Score (GPS) predicts multiple clinical endpoints related to disease aggressiveness in men with low- and intermediate-risk prostate cancer.This study validated Oncotype DX prostate cancer test as predictor of biochemical recurrence, rise in prostate-specific antigen (PSA) following surgery, which is measure of longer-term outcomes for aggressive disease.It also reconfirmed test's ability to predict adverse pathology from biopsy, as previously demonstrated in a published validation study performed by University of California, San Francisco.Important endpoints of this landmark prostate cancer study include development of metastatic disease and outcomes in African-American patients.More than 50 pct of men diagnosed with prostate cancer have low-risk disease with less than three pct chance of developing advanced, life-threatening disease.  Full Article

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

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