Sysmex Inostics, Kobe, Japan, has received Japanese approval to manufacture and sell its OncoBEAM RAS CRC molecular test for colorectal cancer patients. The OncoBEAM tests for mutations in blood-based circulating DNA (ctDNA) in the RAS gene.
The approval is the first in Japan for a liquid biopsy test. According to Sysmex, the kit will reduce the need for invasive tissue biopsies, and will help to expedite treatments.
The OncoBEAM test was developed jointly by Sysmex Inostics and Merck, Darmstadt, Germany. The test received a CE mark in 2016. The Japanese National Cancer Center Hospital East and seven other facilities in Japan evaluated the OncoBEAM in order for the test to receive approval.
By providing timely information from ctDNA in the bloodstream of colorectal cancer patients, OncoBEAM RAS testing can be used by physicians to determine whether to use molecularly targeted anti-EGFR drugs such as cetuximab in the course of treatment. Sysmex plans to introduce an OncoBEAM RAS CRC assay service to further widen adoption of this important capability for precision medicine for Japanese patients. The company also plans to apply for national insurance coverage.
For more information, visit Sysmex Inostics.