Highlighting the importance of intrinsic biological subtypes within the breast cancer spectrum, the updated guidelines, which are determined bi-annually, have been recently published online in the advance access section of Annals of Oncology and will appear in the
"We're witnessing a transformation in the treatment approach to breast cancer with the identification and better understanding of the fundamental tumor subtypes," says
Focused on the development of treatment recommendations to improve patient outcomes in the immediate future, the 51-member international
According to the new guidelines, although there are several tests that provide prognostic information, where uncertainty remains, only Oncotype DX is included as the multi-gene test that "may also be used where available to predict chemotherapy responsiveness" in estrogen receptor-positive breast cancer. In addition to existing studies that have already been conducted to validate Oncotype DX®, a major ongoing prospective trial called TAILORx will provide further insight on the predictive and prognostic value of the test.
"Inclusion in the St. Gallen's guidelines represents an important recognition of the value of Oncotype DX in enabling more individualized treatment decisions by the international medical community," says
To date, Oncotype DX® has been evaluated in 13 independent clinical studies involving more than 4,000 patients to predict the likelihood of chemotherapy benefit as well as risk for disease recurrence in early-stage breast cancer. Furthermore, 11 studies in five countries including
Its lead product, the Oncotype DX breast cancer test, has been shown to predict the likelihood of chemotherapy benefit as well as risk for disease recurrence in early-stage breast cancer. The test is also validated for use in certain node-positive breast cancer patients. Oncotype DX has been extensively evaluated in thirteen clinical studies involving more than 4,000 breast cancer patients worldwide, including a large validation study published in
The Oncotype DX colon cancer test is the first multigene expression test commercially available that has been clinically validated to predict risk for disease recurrence in patients with stage II colon cancer. Five studies involving more than 3,200 patients have been conducted to validate the Oncotype DX colon cancer test.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the belief that the Oncotype DX is significant in changing treatment decisions in early stage breast cancer; the company's belief that the Oncotype DX Recurrence Score cannot be predicted by other factors such as age or individual biomarkers; the company's belief that the Oncotype DX is cost effective and can reduce the cost of treatment; the company's belief that it has the opportunity to advance the quality of cancer treatment decisions and that the inclusion of Oncotype DX in the St. Gallen guidelines will enable greater international utilization of Oncotype DX. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results
should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the risks and uncertainties associated with the regulation of the company's tests; the impact of competition; the results of clinical studies; the results of cost effectiveness studies; the applicability of clinical study results to actual outcomes; and the other risks set forth in the company's filings with the
Dean Schorno Genomic Health650-569-2281 Email Contact Media: Emily Faucette Genomic Health415-595-9407 Email Contact
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