Benzinga | Aug 16, 2021 06:02AM EDT

Exact Sciences Receives Regulatory Approval For The Oncotype DX Breast Recurrence Score Program In Japan

Exact Sciences Corp. (NASDAQ:EXAS) today announced that Japan's Ministry of Health, Labor and Welfare (MHLW) has approved the Oncotype DX Breast Recurrence Score(r) Program. 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(r) accessible to breast cancer patients in Japan.

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(r) 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.