Genomic Health, Inc. announced that results from a new analysis of the Trial Assigning IndividuaLized Options for Treatment (Rx), or TAILORx, confirm the original, definitive conclusions reported last year with additional detail on clinical risk, focusing on patients with early-stage breast cancer who are age 50 years or younger. These findings, published in The New England Journal of Medicine and presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting, showed that stratifying patients by clinical risk (tumor size and histologic grade) alone does not predict chemotherapy benefit. Clinical risk provides prognostic information that is complementary to the Oncotype DX Breast Recurrence Score® test and may help identify younger women who benefit from more effective therapy. A secondary objective of TAILORx, the largest ever breast cancer treatment trial, sponsored by the National Cancer Institute (NCI), and led by the ECOG-ACRIN Cancer Research Group, was to evaluate whether clinical risk provides additional prognostic or predictive information to the Recurrence Score (RS) results. Of 9,427 women in TAILORx with a RS and clinical risk information, 70 percent were determined to be low clinical risk (tumor =3 cm and low grade, =2 cm and intermediate grade, or =1 cm and high grade) and 30 percent were identified as high clinical risk (not meeting low clinical risk criteria). While clinical risk provided additional prognostic information across all RS groups, disease-free survival and distant recurrence-free interval rates were similar with and without chemotherapy in the entire RS 11-25 group irrespective of clinical risk. The TAILORx results, presented during the Plenary Session at the 2018 ASCO Annual Meeting and simultaneously published in The New England Journal of Medicine, are elevating Oncotype DX to a new global standard of care with increasing, and more consistent, use of Oncotype DX by physicians worldwide for all medically eligible patients. Additionally, important guidelines globally distinguish Oncotype DX from other prognostic-only tests based on clinical evidence and the critical importance of predicting chemotherapy benefit. This includes the recent update to ASCO guidelines, which increased the proportion of women who can be effectively treated without chemotherapy based on the strong and highest level of evidence from TAILORx, as well as National Comprehensive Cancer Network (NCCN) guidelines, which were updated last fall to categorize Oncotype DX as the only "preferred" test for chemotherapy treatment decision-making for patients with node-negative early-stage breast cancer. The landmark TAILORx study is also having an important impact on global reimbursement of Oncotype DX, including in Germany. Following the German Institute for Quality and Efficiency in Health Care's (IQWiG's) positive assessment, the German Federal Joint Committee (G-BA) is expected to make a decision on Oncotype DX reimbursement at its plenary meeting on June 20.