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Sysmex Gets Japanese Manufacturing, Marketing Approval for Colorectal Cancer Screening Assay

NEW YORK – Sysmex announced today that it has obtained manufacturing and marketing approval from the Japanese Ministry of Health, Labor, and Welfare for its OncoBEAM RAS Colorectal Kit which tests for mutations in the RAS gene in blood-based circulating tumor DNA (ctDNA) for late-stage CRC patients.

Sysmex believes that physicians can use the assay to help determine whether to use anti-EGFR drugs during treatment.

The firm said the recent approval will provide Japanese CRC patients with a viable alternative to tissue testing for cancer detection, in addition to speeding up delivery of molecular information required to accurately prescribe therapies.

Sysmex plans to launch an OncoBEAM RAS CRC Assay service to further expand adoption in the Japanese population, as well as apply for national insurance coverage.

Jointly developed by Sysmex and Merck KGgA, the kit received CE marking in 2016.