On June 3, 2019 Genomic Health, Inc. (NASDAQ: GHDX) reported that its Oncotype DX Breast Recurrence Score test and the TAILORx results have been recommended to guide chemotherapy treatment use in patients with node-negative early-stage breast cancer by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in its 2019 Guidelines for Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy (Press release, Genomic Health, JUN 3, 2019, View Source [SID1234536824]). Using the strong and highest level of evidence from TAILORx, the updated ASCO (Free ASCO Whitepaper) guidelines increase the proportion of women who can be effectively treated without chemotherapy based on the Oncotype DX results, highlighting the importance of testing all medically eligible patients as standard of care.

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"We are pleased that the ASCO (Free ASCO Whitepaper) guidelines have been updated to reflect the findings from the landmark TAILORx trial, the practice-changing results of which demonstrated that the Oncotype DX Recurrence Score result can be used to guide chemotherapy decision-making for all medically eligible women with the most common form of early-stage, invasive breast cancer," said Steven Shak, M.D., chief scientific officer, Genomic Health. "The TAILORx results have influenced positive treatment guideline recommendations from ASCO (Free ASCO Whitepaper) and other organizations around the world, elevating the Oncotype DX test to a new global standard of care."

TAILORx, sponsored by the National Cancer Institute (NCI) and conducted by the ECOG-ACRIN Cancer Research Group, involved 10,273 women across 1,100 trial sites in six participating countries. The study results, which were presented during the Plenary Session at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting last June and simultaneously published in The New England Journal of Medicine, demonstrated that the Oncotype DX Breast Recurrence Score test definitively identifies the vast majority of women with early-stage breast cancer who receive no benefit from chemotherapy, and the important minority of women for whom chemotherapy benefit can be life-saving. Patients with an Oncotype DX Breast Recurrence Score result of 25 or less – up to about 80 percent of patients – may be safely spared chemotherapy and its well-known side effects, while those with scores of 26 to 100 may receive a life-saving benefit from chemotherapy.

"The updated ASCO (Free ASCO Whitepaper) breast cancer treatment guidelines based on the TAILORx results will provide physicians with clarity and confidence that they are selecting the right treatment for each of their breast cancer patients," said Harold A. Burstein, M.D., Ph.D., medical oncologist at the Dana-Farber Cancer Institute. "Having guidelines that reflect the latest ground-breaking research is critical in ensuring that physicians incorporate standard-of-care technology, such as the Oncotype DX test, when making clinical decisions about treatment for their patients with breast cancer."

New TAILORx Data Analysis at 2019 ASCO (Free ASCO Whitepaper) Annual Meeting
New analysis of a secondary endpoint of the TAILORx trial will be presented in the "Breast Cancer—Local/Regional/Adjuvant" oral abstract session at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting. The presentation, titled "Impact of clinical risk category on prognosis and prediction of chemotherapy benefit in early breast cancer (EBC) by age and the 21-gene recurrence score (RS) in TAILORx," will take place on Monday, June 3. The abstract (#503) can be accessed here.

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 androgen receptor (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 Genomic Health. With more than 1 million 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.MyProstateCancerTreatment.org.