Milestone underscores test’s significant role as a global standard-of-care in guiding personalized breast cancer treatment
Exact Sciences Corp., a leading provider of cancer screening and diagnostic solutions, has announced that its Oncotype DX Breast Recurrence Score test has now been used by more than two million breast cancer patients worldwide. The test, which has more than two decades of clinical validation, helps guide treatment decisions by identifying patients who are likely or unlikely to benefit from chemotherapy, making it a global standard in personalized breast cancer care.
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Brian Baranick, General Manager of Precision Oncology at Exact Sciences, said that reaching this milestone reflects the trust clinicians and patients place in the Oncotype DX test. He explained that the test has helped move breast cancer care beyond a one-size-fits-all approach by providing predictive results that allow patients to make confident, individualized treatment choices, including safely avoiding chemotherapy when appropriate. Baranick emphasized the test’s ongoing contribution to precision oncology and its impact on patient care worldwide.
For more than 22 years, the Oncotype DX test has remained the only genomic assay proven to predict the benefit of adjuvant chemotherapy. By personalizing treatment decisions, the test has spared an estimated 1.6 million patients from potentially unnecessary chemotherapy. Analysis of its use in HR+, HER2- patients suggests an average lifetime savings of approximately $10,000 per patient in the U.S. healthcare system.
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The test delivers both prognostic and predictive insights. Prognostic information provides the likelihood of cancer recurrence, while predictive results indicate whether a patient is likely to benefit from a specific therapy. The Recurrence Score integrated with the RSClin tool adds further precision, combining genomic results with clinical and pathological factors to provide a more detailed assessment of recurrence risk and expected chemotherapy benefit.
The Oncotype DX Breast Recurrence Score test has been validated across diverse populations to ensure equitable access regardless of race or ethnicity. It is used in over 100 countries and is the only genomic breast cancer test to earn a Category 1A recommendation in the National Comprehensive Cancer Network Clinical Practice Guidelines. Supported by landmark trials including NSABP B-20, SWOG 8814, TAILORx, and RxPONDER, the test is recognized as a standard-of-care solution for patients with early-stage breast cancer and continues to shape individualized treatment worldwide.
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