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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The U.K.'s National Institute for Health and Clinical Excellence, or NICE, issued draft guidance on four tests used to guide decisions about the use of chemotherapy in people with early breast cancer following consultations on previous drafts and the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 The draft guidance recommends the use of Oncotype DX in people with oestrogen receptor positive, lymph node negative and human epidermal growth factor receptor 2 negative early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 The draft guidance also highlights that it has not been able to support the routine use of the IHC4, MammaPrint or Mammostrat tests but recommends that they are used in a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
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September 9, 2014
08:05 EDTGHDXGenomic Health to present positive results from nine studies of Oncotype DX
Genomic Health announced that results from nine studies of Oncotype DX in prostate, breast and renal cancers will be presented at the European Society for Medical Oncology, or ESMO, 2014 Congress in Madrid, September 26 30. Included in the program is the first presentation of strongly positive results from an additional large independent clinical validation study of the Oncotype DX prostate cancer test, conducted in collaboration with the Center for Prostate Disease Research, Rockville. This new study demonstrates the test's ability to predict a rise in prostate-specific antigen, or PSA, following surgery and reconfirms Oncotype DX as a predictor of adverse pathology from the biopsy, as previously demonstrated in a published validation study performed by the University of California, San Francisco.

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