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German Health Technology Assessment Body (IQWiG) Concludes Only Oncotype DX® has Sufficient Evidence to Guide Breast Cancer Adjuvant Chemotherapy Decisions Based on Landmark TAILORx Study Results
IQWiG's technical assessment will inform the Federal Joint Committee (G-BA) official reimbursement procedure. In
"With IQWiG's recognition of the unique value the Oncotype DX test provides, we believe we are one step closer to ensuring reimbursed access to tens of thousands of breast cancer patients diagnosed in
IQWiG's conclusion is based on results from TAILORx, the largest randomized adjuvant breast cancer treatment trial ever conducted, which were recently published in
Study results demonstrated that the Oncotype DX Breast Recurrence Score test provides definitive long-term evidence about the magnitude of chemotherapy benefit, identifying the vast majority of women with early-stage breast cancer who receive no significant benefit from chemotherapy, as well as the important minority of women for whom chemotherapy can be life-saving. Thus, the test can greatly reduce both overtreatment and undertreatment with chemotherapy.
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. With more than 900,000 patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatement.org.
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 benefits of the Oncotype DX Breast Recurrence Score 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 results of clinical studies, including the TAILORx study; the applicability of clinical study results to actual outcomes; the ability of the test results to change treatment decisions and improve patient outcomes; the risks and uncertainties associated with the regulation of the company's tests; the risk that the company may not obtain or maintain reimbursement, domestically or abroad, including in
NOTE: The Genomic Health logo, Oncotype, Oncotype DX, Breast Recurrence Score, Recurrence Score, Oncotype DX AR-V7 Nucleus Detect, Oncotype DX DCIS Score, Oncotype DX Genomic Prostate Score, and Oncotype IQ are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.
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