New Data Highlight the Positive Impact of Exact Sciences’ Oncotype DX® Test on Patient Care and Healthcare Efficiency

Exact Sciences, a leading provider of cancer screening and diagnostic tests, today announced the presentation of new data further reinforcing the utility of its Oncotype DX Breast Recurrence Score^® test at the 19th St. Gallen International Breast Cancer Conference in Vienna, Austria.

A UK study¹ explored the benefits of shifting the testing point to the pre-surgery setting by utilizing Oncotype DX on breast cancer core biopsy samples instead of surgical specimens. This multi-centre, prospective, randomized controlled trial (PreDX) included 341 patients eligible for Oncotype DX testing across 17 breast cancer units. The findings showed that testing on core biopsy led to a reduction in time to treatment outcome, including a clinically meaningful eight-day reduction in time from surgery to start of adjuvant treatment. In addition, testing before surgery improved the patient experience, with a significant reduction in anxiety and depression scores.

“The findings show that testing on core biopsy with Oncotype DX is reliable and highlight the potential advantages of this approach for patients and breast cancer services,” said Dr. Henry Cain, lead investigator and Consultant Surgeon at the Royal Victoria Infirmary, Newcastle upon Tyne, UK. “Importantly, the time to initiate adjuvant therapy could be further optimized by reducing clinical appointments, positively impacting the overall patient experience.”

The test success rate on the core biopsy was 99.1%, confirming previous studies^2,3 which showed that core biopsy samples produce Recurrence Score^® results highly concordant with those from surgical specimens and that Recurrence Score result distributions remain consistent between core biopsy and surgical samples when assessed by patient age (<50 versus ≥50 years) and nodal involvement.

“As a breast cancer patient, knowing the test result before surgery would have given me peace of mind and confidence,” said Jennifer D. from Newcastle upon Tyne, UK. “I believe that early testing can significantly impact patients’ lives, aiding in their decision-making process and positively affecting not only their immediate family but also the relatives and friends who love and care for them.”

Separately, a Swedish economic analysis⁴, also presented at the congress, showed that delaying the adoption of the Oncotype DX test in clinical practice leads to decreased financial savings and negatively affects patient outcomes. Using a decision-analytic model to compare the Oncotype DX test with other available genomic tests and the traditional (non-genomic) approach, the analysis demonstrated that the Oncotype DX test leads to superior patient outcomes at reduced costs. The results contribute to the growing body of evidence and support the test’s integration into clinical practice. This valuable test aids in making more informed treatment decisions, enhancing the quality of care by customizing chemotherapy treatment to meet individual patient needs, and advancing towards a more efficient and patient-centered healthcare system.

About the Oncotype DX Breast Recurrence Score test
The Oncotype DX Breast Recurrence Score test is designed to facilitate personalized clinical decisions by providing information about the biology of an individual breast cancer, with the potential to deliver financial benefits for healthcare systems. The test was first made available to patients in 2004, and over 1.5 million patients around the world have benefited from it. It is incorporated in major breast cancer treatment guidelines, including those of the European Society for Medical Oncology (ESMO) and the St. Gallen International Breast Cancer Conference, as well as the American Society of Clinical Oncology (ASCO^®) and the National Comprehensive Cancer Network (NCCN^®) in the U.S.

To learn more about the test, visit: www.oncotypedxtest.com/

About Exact Sciences
A leading provider of cancer screening and diagnostic tests, Exact Sciences gives patients and health care professionals the clarity needed to take life-changing action earlier. Building on the success of the Cologuard^® and Oncotype^® tests, Exact Sciences is investing in its pipeline to develop innovative solutions for use before, during, and after a cancer diagnosis. For more information, visit ExactSciences.com, follow Exact Sciences on X (formerly known as Twitter) @ExactSciences, or find Exact Sciences on LinkedIn and Facebook.

NOTE: Oncotype, Oncotype DX Breast Recurrence Score, Breast Recurrence Score, and Recurrence Score are registered trademarks of Genomic Health, Inc., a wholly owned subsidiary of Exact Sciences. Exact Sciences and Cologuard are registered trademarks of Exact Sciences Corporation. Cologuard is 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 regarding our expectations for the commercialization of the Cologuard Plus test and the performance of the Cologuard Plus test in a commercial setting. 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.

¹ Cain H., et al. St. Gallen International Breast Cancer Conference, 2025. Abstract P079.

² Jakubowski DM, et al. J Surg Oncol. 2020.

³ Nasser A, et al. San Antonio Breast Cancer Symposium, 2023. Abstract PO-08-09.

⁴ Appelberg K., et al. St. Gallen International Breast Cancer Conference, 2025. Abstract P460.

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