Exact Sciences Corp. announced that recommended use of its Oncotype DX Breast Recurrence Score® test in early-stage breast cancer patients has been expanded by the American Society of Clinical Oncology (ASCO) in its 2022 Biomarkers for Adjuvant Endocrine and Chemotherapy in Early-Stage Breast Cancer guideline update. The test is now recommended for use in postmenopausal patients with up to three positive axillary lymph nodes and is the only test recommended for use in premenopausal patients with node-negative disease.

Importantly, the test is recommended irrespective of clinical risk, and Oncotype DX® is the most strongly recommended with the higher evidence quality of all multigene tests included in the guidelines. The updated guidelines incorporate results from the RxPONDER trial published in The New England Journal of Medicine.ii The study demonstrated that the test identifies a majority of early-stage breast cancer patients with one to three positive nodes who may be spared chemotherapy. Postmenopausal women with Oncotype DX Breast Recurrence Score® results of 0 to 25 did not show benefit from the addition of chemotherapy to hormone therapy.

Premenopausal women with a Recurrence Score result of 0 to 25 received a 2.4% benefit from chemotherapy in terms of distant recurrence at five years. Approximately one-third of patients diagnosed with hormone receptor (HR)-positive, HER2-negative early breast cancer have a tumor that has spread to their lymph nodes. The vast majority of these patients currently receive chemotherapy even though approximately 85% of them have Recurrence Score results of 0 to 25.

In addition, about two out of three early-stage breast cancer patients are postmenopausal. 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. In breast cancer, 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. For patients with advanced and metastatic cancer, the company offers the Oncotype MAP™ Pan-Cancer Tissue test, a rapid, comprehensive tumor profiling panel, which provides results in three to five business days[viii] and allows physicians to understand a patient's tumor profile and recommend actionable targeted therapies or clinical trials. With more than 1 million patients tested in more than 90 countries, the Oncotype DX tests have redefined medicine by making genomics a critical part of cancer diagnosis and treatment.