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June 10, 2014
05:54 EDTGHDXGenomic Health announces results of three studies with Oncotype DX test
Genomic Health announced results of three studies with the Oncotype DX breast cancer test at the recent 2014 American Society of Clinical Oncology Annual Meeting. The PACS01 trial was a large study conducted in France which compared six cycles of fluorouracil, epirubicin, and cyclophosphamide with three cycles of FEC followed by three cycles of docetaxel in 1,999 node positive breast cancer patients. The study presented at ASCO2 included 530 patients from the original PACS01 trial and assessed the association of the Oncotype DX Recurrence Score results with distant recurrence in hormone-receptor-positive, node positive patients treated with either FEC or FEC-D. Results were consistent with those of a similar study3 conducted previously, and showed that the Recurrence Score was a significant predictor of distant recurrence and disease free survival in both treatment arms. Importantly, there was no indication that patients with low Recurrence Score results benefited from the addition of docetaxel to their treatment regimen. A comparison study evaluated if the information provided by Oncotype DX and the Risk of Recurrence scores are equivalent. Specifically, results in 52 node negative, estrogen receptor-positive, post-menopausal, tamoxifen-treated invasive breast cancer patients revealed a very low concordance between Oncotype DX and ROR results. Results of a large, positive study6 confirm that the Oncotype DX Recurrence Score results and quantitative ER expression predict late distant recurrence risk in certain early-stage invasive breast cancer patients after initial tamoxifen therapy. These results suggest that the Oncotype DX test may help identify which patients have greater potential to benefit from extended hormonal treatment beyond five years. The results suggest that extending tamoxifen beyond five years may be most beneficial in patients with high and intermediate Recurrence Score results with higher quantitative ER expression. Conversely, patients with low Recurrence Score results would be expected to have limited benefit from extended tamoxifen beyond five years due to much lower risk for late distant recurrence.
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.

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