Oncotype DX Breast Recurrence Score® Test Surpasses 2 Million Patients Worldwide

Milestone underscores test’s significant role as a global standard-of-care in guiding personalized breast cancer treatment

The predictive utility of this test helped an estimated 1.6 million patients safely avoid potentially unnecessary chemotherapy

Economic models demonstrate improved outcomes and the potential for U.S. system-wide cost savings

MADISON, Wis.--(BUSINESS WIRE)--Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, today announced a significant milestone for its flagship Oncotype DX Breast Recurrence Score^® test: more than two million breast cancer patients worldwide have now used the test to help guide treatment decisions. Backed by more than two decades of clinical evidence, the test has become a global standard-of-care by identifying patients who are – and are not – likely to benefit from chemotherapy.

“Reaching 2 million patients reflects the deep trust clinicians and patients place in the Oncotype DX^® test,” said Brian Baranick, General Manager, Precision Oncology at Exact Sciences. “For more than two decades, it has helped move breast cancer care beyond a one-size-fits-all treatment decision, delivering predictive results that support confident, individualized decisions and enabling many patients to make the choice to safely avoid chemotherapy without compromising outcomes. We’re proud of the test’s ongoing impact on precision oncology worldwide.”

Twenty-two years after the trailblazing test first revolutionized breast cancer treatment, the Oncotype DX test remains the only genomic test proven to predict adjuvant chemotherapy benefit. The test has played a pivotal role in personalizing care, de-escalating treatment, and sparing an estimated 1.6 million patientsⁱ (of the 2 million tested) around the world from potentially unnecessary treatment.ⁱⁱ Using a published economic model, it is estimated that use of the Oncotype DX test to inform adjuvant treatment decisions among HR+, HER2- patients resulted in average lifetime savings of approximately $10,000 per patient in the U.S. healthcare system.

Predictive vs. prognostic and why it matters

The Oncotype DX Breast Recurrence Score test delivers personalized genomic results to guide treatment decisions for patients with early-stage HR+, HER2- breast cancer. It is the only genomic assay proven to be both prognostic of distant recurrence risk and predictive of chemotherapy benefit.

Predictive and prognostic tests serve very different purposes; prognostic tests provide insight into how a cancer may behave over time – such as the likelihood of recurrence – but they do not provide information about treatment benefit. Predictive biomarkers help determine whether a patient is likely to benefit from a specific therapy, information that can directly guide treatment choice and support more individualized care. Chemotherapy benefit prediction remains a critical need in individualized breast cancer treatment.

By integrating Recurrence Score^® results with clinical and pathological factors, the RSClin^® tools can provide even deeper understanding of the estimated genomic risk to help inform clinical decision-making. For patients and clinicians seeking additional clarity, it provides more individualized estimates of distant recurrence risk and absolute chemotherapy benefit.

The Oncotype DX Breast Recurrence Score test’s performance has been consistently validated across diverse populations – ensuring equitable access regardless of race or ethnicity – and is used in more than 100 countries worldwide. It is the only genomic breast cancer test that has earned a Category 1A recommendation in the National Comprehensive Cancer Network (NCCN^®) Clinical Practice Guidelines, providing the highest level of evidence to inform personalized treatment decisions. Recognized as a standard-of-care for patients with early-stage breast cancer, the test is supported by a robust body of clinical evidence from landmark trials, including NSABP B-20, SWOG 8814, TAILORx, and RxPONDER.

About Exact Sciences Corp.

A leading provider of cancer screening and diagnostic tests, Exact Sciences (Nasdaq: EXAS) helps patients and health care providers make timely, informed decisions before, during, and after a cancer diagnosis. The company’s growing portfolio includes well-established brands such as Cologuard^® and Oncotype DX^®, along with innovative solutions like Cancerguard^® for multi-cancer early detection and Oncodetect^® for molecular residual disease and recurrence monitoring. Exact Sciences continues to invest in a robust pipeline of advanced cancer diagnostics aimed at improving outcomes. For more information, visit ExactSciences.com, follow @ExactSciences on X, or connect on LinkedIn and Facebook.

NOTE: Oncotype DX, Oncotype DX Breast Recurrence Score, Recurrence Score, Oncodetect, and RSClin are trademarks of Genomic Health, Inc., a wholly owned subsidiary of Exact Sciences. Exact Sciences, Cologuard and Cancerguard are trademarks of Exact Sciences Corporation. Cologuard, Oncodetect, Cancerguard, Riskguard, and OncoExTra are only available in the United States.

Forward-Looking Statement

This news release contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs, or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions, and events to differ materially from those anticipated. Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding our expectations for our products and services and their impact on patients; our strategies, commercialization efforts, positioning, capabilities and expectations for future events or performance. Risks and uncertainties that may affect our forward-looking statements are described in the Risk Factors sections of our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments, or otherwise.

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^i This estimate was calculated using the total global lifetime volume of patients that had an Absolute Chemotherapy Benefit result of <1% using the Oncotype DX Breast Recurrence Score test, as this value is defined for each nodal and menopausal (or assumed by age) status.

^ii Data on File as of 12/2025 at Genomic Health, Inc