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Exact Sciences' Oncotype DX Breast Recurrence Score Assay Receives Japanese Regulatory Approval

NEW YORK – Exact Sciences said on Monday that Japan's Ministry of Health, Labor and Welfare has approved the company's Oncotype DX Breast Recurrence Score test and software for breast cancer patients in Japan.

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, Exact said. The Oncotype DX Breast Recurrence Score Program approved in Japan combines the Oncotype DX Breast Recurrence Score test and software specifically developed for the Japanese market, the company noted.

Exact now plans to pursue coverage for the program under Japan's universal healthcare insurance system and launch the test through its Japanese affiliate, Exact Sciences KK.

"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," Kevin Conroy, Exact's chairman and CEO, said in a statement. "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."

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