Key Developments: Genomic Health Inc (GHDX.O)

GHDX.O on Nasdaq

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Latest Key Developments (Source: Significant Developments)

Genomic Health Inc gives Q4 2014 revenue guidance in line with analysts' estimates; sees FY 2014 revenue guidance at low end of prior guidance - Conference Call
Tuesday, 4 Nov 2014 04:30pm EST 

Genomic Health Inc:Expects Q4 2014 revenue to be in the range of 7pct year-over-year.Expects FY 2014 total revenue at the low end of full-year guidance.Reported revenue of $68.82 million in Q4 2013.Reported revenue of $261.60 million in FY 2013.FY 2014 revenue of $282.22 million - Thomson Reuters I/B/E/S.Q4 2014 revenue of $73.56 million - Thomson Reuters I/B/E/S.  Full Article

Genomic Health Inc announces positive results from clinical validation study of oncotype DX as predictor of near- and long-term outcomes in racially diverse group of prostate cancer patients
Monday, 29 Sep 2014 08:00am EDT 

Genomic Health Inc:Says positive results from an independent clinical study of Oncotype DX prostate cancer test, conducted with the Uniformed Services University of the Health Sciences' (USU) Center for Prostate Disease Research supported by team of investigators with USU.This new large study reconfirmed the biopsy-based test's Genomic Prostate Score (GPS) as a predictor of adverse pathology at surgery and, for the first time, validated GPS as a strong independent predictor of a rise in prostate-specific antigen (PSA) following surgery (biochemical recurrence).In meeting these two endpoints, the Oncotype DX prostate cancer test provides both clinically actionable and long-term outcomes information for men with newly diagnosed low- and intermediate-risk prostate cancer.Furthermore, the study demonstrated that Oncotype DX is similarly predictive of outcomes in both Caucasian and African-American men.  Full Article

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

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