On August 16, 2021 Exact Sciences Corp. (Nasdaq: EXAS) reported that Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved the Oncotype DX Breast Recurrence Score Program (Press release, Exact Sciences, AUG 16, 2021, View Source [SID1234586599]). The test helps guide chemotherapy treatment recommendations and provides risk of distant recurrence in patients with hormone receptor-positive, HER2-negative early-stage breast cancer with up to three positive lymph nodes. MHLW approval is a critical step in making Oncotype DX accessible to breast cancer patients in Japan.

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Breast cancer is the most common cancer in Japanese women, and more than 90,000 new breast cancer cases were diagnosed in Japan in 2020.i The Oncotype DX Breast Recurrence Score Program approved in Japan combines the Oncotype DX Breast Recurrence Score test and software developed for the Japanese market. Exact Sciences plans to pursue coverage under Japan’s universal healthcare insurance system and launch the test through its Japanese affiliate, Exact Sciences K.K.

"MHLW’s approval of Oncotype DX is great news for breast cancer patients in Japan and reflects the powerful evidence backing the Oncotype DX test," said Kevin Conroy, chairman and CEO. "Our international team is enabling new areas of growth for our current advanced cancer tests and will accelerate access to future innovative tests for patients around the world."

The Oncotype DX test provides information allowing doctors and patients to personalize treatment plans with greater confidence.ii While chemotherapy is routinely offered, research shows that only a minority of patients with early-stage breast cancer will actually benefit.iii Oncotype DX is the only test validated to determine which patients will benefit from chemotherapy and provides critical information beyond traditional prognostic factors.iv-viii The test is supported by prospective outcomes data from the TAILORxvii and RxPONDERviii studies, which show that most patients with either node-negative or node-positive disease can be spared chemotherapy when decisions are guided by Oncotype DX.

About Oncotype DX
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. In prostate cancer, the Oncotype DX Genomic Prostate Score test predicts disease aggressiveness and further clarifies the current and future risk of the cancer prior to treatment intervention, and the Oncotype DX AR-V7 Nucleus Detect test helps determine which patients with metastatic castration-resistant prostate cancer (mCRPC) are resistant to androgen receptor (AR)-targeted therapies. The Oncotype DX AR-V7 Nucleus Detect test is performed by Epic Sciences at its centralized, CLIA-certified laboratory in San Diego and offered exclusively by Exact Sciences. The Oncotype MAP Pan-Cancer Tissue test is a rapid, comprehensive tumor profiling panel that aids therapy selection for patients with advanced, metastatic, refractory, or recurrent cancer. With more than 1 million patients tested in more than 90 countries, the Oncotype tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatment.org.