Underscoring the growing international impact of the Oncotype DX Breast Recurrence Score® test, two European-based studies involving patients from
"Oncotype DX tests have contributed to precision medicine in breast cancer for nearly 15 years, and there is now a growing body of evidence for their predictive value and clinical utility in guiding treatment selection for men with early-stage, as well as metastatic prostate cancer," said
Oncotype DX in Node-negative and Node-positive Breast Cancer
Additionally, results from a real-life, decision-impact study of breast cancer patients in
Importantly, in each country, the Oncotype DX Breast Recurrence Score result, when high, also identified the minority of patients for whom chemotherapy is potentially life-saving, highlighting the distinctive predictive value that only the Oncotype DX test delivers.
"These new results strengthen published findings from our PlanB study and show the unique value of adding genomic information provided by the Oncotype DX test to better target chemotherapy. Oncotype DX identifies patients who can safely be spared chemotherapy toxicity and side effects. Furthermore, we have to be concerned about a relevant proportion of patients who seem to be undertreated if the risk of recurrence is evaluated using only traditional clinical parameters," said Prof.
Oncotype DX Optimizes Treatment in Early-stage and Metastatic Prostate Cancer
Based on results from a published study, the
The Oncotype DX GPS test is the only genomic assay designed for men at the time of diagnosis with clinically low-risk or favorable intermediate-risk cancer to help make treatment decisions based on their likelihood of adverse pathology. Developed by
In metastatic prostate cancer, presentations included two studies of the Oncotype DX AR-V7 Nucleus Detect, a CTC-based, liquid biopsy test that helps determine which patients with metastatic castration-resistant prostate cancer (mCRPC) are resistant, or not, to AR-targeted therapies, such as enzalutamide and abiraterone, and which patients may benefit from chemotherapy. The Oncotype DX AR-V7 Nucleus Detect test is commercially available in
A new analysis, combining data from two published studies, confirmed that the Oncotype DX AR-V7 Nucleus Detect test for AR-V7 protein is a predictive biomarker for identifying patients who will not respond to additional AR-targeted therapy (Poster #848P). These data further support that detection of nuclear-localized AR-V7-positive circulating tumor cells (CTCs) by the Oncotype DX test indicates that the patient will not benefit from additional treatment with commonly-prescribed AR-targeted therapy and should consider switching to an alternative therapy to increase survival.
Separately, an independent study of the Oncotype DX AR-V7 Nucleus Detect test conducted by Epic Sciences in collaboration with its academic partners confirmed that the use of AR-V7 optimizes therapy guidance over risk assessment alone (Poster #836P).
About Oncotype DX®
The Oncotype DX® portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. The company's flagship product, the Oncotype DX Breast Recurrence Score® test, is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score® test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. In prostate cancer, the Oncotype DX Genomic Prostate Score® test predicts disease aggressiveness and further clarifies the current and future risk of the cancer prior to treatment intervention and the Oncotype DX AR-V7 Nucleus Detect™ test helps determine which patients with metastatic castration-resistant prostate cancer (mCRPC) are resistant to AR-targeted therapies. The Oncotype DX AR-V7 Nucleus Detect test is performed by Epic Sciences at its centralized, CLIA-certified laboratory in San Diego and offered exclusively by
About Genomic Health
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the results of clinical studies; the impact of clinical studies on reimbursement and test adoption; the applicability of clinical study results to actual outcomes; the commercial performance of the company's tests; and the benefits of the test to physicians, patients and payors. 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 risk that the company may not obtain or maintain adequate levels of reimbursement, domestically or abroad, for its existing tests and any future tests it may develop; the
ability of the company to achieve expanded coverage of reimbursement for its existing tests and the ability of any such expanded coverage to result in additional revenue; the ability of test results to change treatment decisions; the risks of competition; the risks and uncertainties associated with the regulation of the company's tests; the results of clinical studies; the applicability of clinical study results to actual outcomes and the ability to demonstrate sufficient clinical utility; unanticipated costs or delays in research and development efforts; and the other risks set forth in the company's filings with the
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