Updated ASCO Guidelines Strongly Recommend Use of the Oncotype DX Breast Recurrence Score® Test in Node-Negative and the Majority of Node-Positive Early-Stage Breast Cancer Patients

  • Oncotype DX® receives highest rating of all multigene tests in the guidelines for quality of evidence and strength of recommendation
  • New guidelines reflect highest level of evidence from independent RxPONDER study, recently published in The New England Journal of Medicine

MADISON, Wis., April 28, 2022 – Exact Sciences Corp. (NASDAQ: EXAS), a leader in advanced cancer diagnostics, today 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.[i]

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 highest evidence quality of all multigene tests included in the guidelines.

“We are pleased that the updated ASCO guidelines recognize the strength of the data supporting Oncotype DX and expand the recommended use of the test based on findings from the RxPONDER study,” said Rick Baehner, M.D., chief medical officer of Precision Oncology at Exact Sciences. “The Oncotype DX test has been used to guide the treatment decisions for more than one million women around the world, and the updated guidelines provide even greater clarity and confidence to physicians in individualizing the discussion of the risks and benefits of chemotherapy with their patients.”

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.[iii]

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.[iv] The vast majority of these patients currently receive chemotherapy[v] even though approximately 85% of them have Recurrence Score results of 0 to 25.[vi] In addition, about two out of three early-stage breast cancer patients are postmenopausal.[vii]

About the Oncotype DX® and Oncotype MAP™ Portfolio of Tests

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 personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about the Oncotype DX and Oncotype MAP tests, visit www.OncotypeIQ.com/

About Exact Sciences Corp.

A leading provider of cancer screening and diagnostic tests, Exact Sciences relentlessly pursues smarter solutions providing the clarity to take life-changing action, earlier. Building on the success of the Cologuard® and Oncotype® tests, Exact Sciences is investing in its product pipeline to support patients before and throughout their cancer diagnosis and treatment. Exact Sciences unites visionary collaborators to help advance the fight against cancer. For more information, please visit the company’s website at www.exactsciences.com, follow Exact Sciences on Twitter @ExactSciences, or find Exact Sciences on Facebook.

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NOTE: Oncotype, Oncotype DX, Oncotype DX Breast Recurrence Score, Oncotype DX Breast DCIS Score, Recurrence Score and Oncotype MAP are trademarks or registered trademarks of Genomic Health, Inc. Exact Sciences and Cologuard are trademarks or registered trademarks of Exact Sciences Corporation. All other trademarks and service marks are the property of their respective owners.

Forward-Looking Statements

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. 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] F. Andre, et al. JCO 2022. 

[ii] Kalinsky K, et al. New Engl J Med. 2021. 

[iii] Kalinsky K, et al. SABCS 2021 GS2-07 

[iv] https://www.swog.org/news-events/news/2021/12/03/rxponder-results-published-nejm

[v] Zhang et al. Breast Can Res Treat. 2020.

[vi] Bello et al. Ann Surg Oncol. 2018.

[vii] Heer E, et al. The Lancet. 2020. 

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