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February 19, 2013
11:15 EDTGHDXGenomic Health Oncotype DX recommended in NICE guidance
The U.K.'s National Institute for Health and Clinical Excellence, or NICE, issued draft guidance on four tests used to guide decisions about the use of chemotherapy in people with early breast cancer following consultations on previous drafts and the submission of a confidential access proposal by the manufacturer of Oncotype DX, Genomic Health (GHDX). The draft guidance recommends the use of Oncotype DX in people with oestrogen receptor positive, lymph node negative and human epidermal growth factor receptor 2 negative early breast cancer, who are assessed as being at intermediate risk, to guide chemotherapy decisions where the manufacturer provides it at the price offered through the confidential access proposal. The recommendation for Oncotype DX applies to people assessed as being at intermediate risk of distant recurrence by decision making tools/protocols currently in use in the NHS and where the decision to prescribe chemotherapy remains unclear, NICE said. The draft guidance also highlights that it has not been able to support the routine use of the IHC4, MammaPrint or Mammostrat tests but recommends that they are used in a research setting to collect evidence about potentially important clinical outcomes and to determine the ability of the tests to predict the efficacy of chemotherapy in people with early breast cancer. Reference Link
News For GHDX From The Last 14 Days
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August 7, 2014
16:20 EDTGHDXGenomic Health sees 2H net losses similar to 1H
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16:19 EDTGHDXGenomic Health reports Q2 EPS (15c), consensus (26c)
Reports Q2 revenue $70.5M, consensus $69.04M. Reports 17% growth in test volume in Q2.
August 6, 2014
08:14 EDTGHDXGenomic Health's Oncotype DX for prostate cancer shows positive results
Genomic Health announced positive preliminary results from an additional independent clinical validation study conducted by the Center for Prostate Disease Research demonstrating that the Oncotype DX Genomic Prostate Score predicts multiple clinical endpoints related to disease aggressiveness in men with low- and intermediate-risk prostate cancer. This study validated the Oncotype DX prostate cancer test as a predictor of biochemical recurrence, a rise in prostate-specific antigen following surgery, which is a measure of longer-term outcomes for aggressive disease. Additional endpoints of this prostate cancer study include the development of metastatic disease and outcomes in African-American patients.

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