Genomic health calculator1/9/2023 ![]() In this article, we provide an overview of the validation and clinical impact studies for the Oncotype DX assay. Clinical studies have consistently shown that the Oncotype DX has a significant impact on decision making in adjuvant therapy recommendations and appears to be cost-effective in diverse health care settings. The assay, which provides information on clinicopathological factors, has been validated for use in the prognostication and prediction of degree of adjuvant chemotherapy benefit in both lymph node-positive and lymph node-negative early breast cancers. The Oncotype DX result is presented as the recurrence score which is a continuous score that predicts the risk of distant disease recurrence. Together with several other genomic assays, Oncotype DX has been incorporated into clinical practice guidelines on biomarker use to guide treatment decisions. It has ushered in the era of genomic-based personalized cancer care for ER-positive primary breast cancer and is now widely utilized in various parts of the world. ![]() Zhen Rong Siow, 1–3 Richard H De Boer, 2,3 Geoffrey J Lindeman, 1–4 G Bruce Mann 2–4ġACRF Stem Cells and Cancer Division, Walter and Eliza Hall Institute of Medical Research, 2Department of Medical Oncology, Peter MacCallum Cancer Centre, 3Familial Cancer Centre, The Royal Melbourne Hospital, 4Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, Parkville, VIC, AustraliaĪbstract: The Oncotype DX ® assay was developed to address the need for optimizing the selection of adjuvant systemic therapy for patients with estrogen receptor (ER)-positive, lymph node-negative breast cancer. ![]()
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