Tumor biomarker tests must have high analytic performance, clinical validity, and clinical utility to be included in major treatment guidelines. The Oncotype DX® Breast Recurrence Score has been validated and provides level 1, category B evidence as defined by Simon et al.1 Consistent results across multiple well-designed studies demonstrate the assay’s robust analytic performance, clinical validity and clinical utility. As a result the assay has been incorporated into multiple guidelines including National Comprehensive Cancer Network (NCCN), American Society of Clinical Oncology (ASCO), National Institute for Health and Care Excellence (NICE), St. Gallen, and European Society for Medical Oncology (ESMO).2-6



1. Simon R. Roadmap for developing and validating therapeutically relevant genomic classifiers. J Clin Oncol. 2005; 23(29):7332-41.
2. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology—Breast Cancer,v.1.2015.
3. Harris L, Fritsche H, Mennel R, et al. American Society of Clinical Oncology 2007 update of recommendations for the use of tumor markers in breast cancer. J Clin Oncol. 2007; 25 (33): 5287-5312.
4. NICE Diagnostics Guidance (DG10) September 2013.
5. Goldhirsch A, Winer EP, Coates AS, et al. Personalizing the treatment of women with early breast cancer: highlights of the St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2013. 2013. Ann Oncol. 2013; 00:1-18.
6. Aebi S, Davidson T, Gruber G, et al. Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2010; 21 Suppl 5: v9-14.


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