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News Breaks
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The U.K.'s National Institute for Health and Clinical Excellence, or NICE, issued draft guidance on four tests used to guide decisions about the use of chemotherapy in people with early breast cancer following consultations on previous drafts and the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 The draft guidance recommends the use of Oncotype DX in people with oestrogen receptor positive, lymph node negative and human epidermal growth factor receptor 2 negative early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 The draft guidance also highlights that it has not been able to support the routine use of the IHC4, MammaPrint or Mammostrat tests but recommends that they are used in a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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May 21, 2015
08:16 EDTGHDXGenomic Health's Oncotype prostate cancer test issued draft LCD determination
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May 20, 2015
08:08 EDTGHDXGenomic Health's Oncotype prostate cancer risk test shows positive results
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May 18, 2015
08:05 EDTGHDXGenomic Health announces results from study on methods to detect bladder cancer
Genomic Health announced positive results from a second, larger liquid biopsy feasibility study demonstrating the Company's ability to detect tumor-specific DNA in urine, which is expected to enable bladder cancer recurrence monitoring. It is estimated that early-stage bladder cancer recurs in only 10 to 15 percent of patients in the first year, and in more than half of patients over time. However, approximately one-third of all cystoscopies a procedure using a thin instrument equipped with a camera and light to look at the inside of the bladder generate false positive results. Genomic Health and its collaborators used the Company's next-generation sequencing and polymerase chain reaction based platforms and refined methodology to target tumor-specific differential DNA methylation and single nucleotide variations. In the study, researchers identified tumor-specific DNA markers in 94 percent of tissue samples and found a strong association between the same markers in urine. These findings are expected to enable accurate monitoring for cancer recurrence in the urine of early-stage bladder cancer patients.
May 15, 2015
11:02 EDTGHDXGenomic Health says Oncotype DX shown to lower overall healthcare costs
Genomic Health announced results from three studies that show the real-world positive impact of the Oncotype DX Genomic Prostate Score and the test's value in managing healthcare costs associated with treatment decisions in low-risk patients. An analysis of the performance of the Oncotype DX GPS in the first 4,000 men tested showed that the test refined patient risk for one in four men across all groups of patients, the company said. In a separate study, researchers analyzed the clinical and economic implications of adding GPS to risk assessment compared to clinical and pathological assessment alone in the management of clinically low-risk prostate cancer. Results showed incorporating GPS into prostate cancer management resulted in a cost reduction of approximately $2,000 per patient in the first three years after diagnosis.
08:31 EDTGHDXGenomic Health announces results from studies of Oncotype DX GPS
Genomic Health announced results from three studies that show the real-world positive impact of the Oncotype DX Genomic Prostate Score and the test's value in managing healthcare costs associated with treatment decisions in low-risk patients. An analysis of the performance of the Oncotype DX GPS in the first 4,000 men tested showed that the test refined patient risk for one in four men across all groups of patients. In a separate study, researchers analyzed Oncotype DX test results from 200 U.S. prostate cancer patients to see how the change in their treatment decision based on the GPS results affected the cost of their treatment. Results showed that immediate treatment costs declined by more than $5,700 per patient. This reduction in costs was associated with increased use of active surveillance from 44 percent to 70 percent of the time. These results indicate that incorporating GPS into treatment decisions can reduce overall healthcare costs within five years. Genomic Health researchers analyzed data compiled from four different Oncotype DX prostate cancer test studies involving 138 African-American patients. Results of this analysis showed that the tumor biology measured by the Oncotype DX GPS was similar between African-American and Caucasian men, reinforcing findings from the second validation study conducted in collaboration with the Uniformed Services University of the Health Sciences' Center for Prostate Disease Research.

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