Japan’s Ministry of Health, Labour and Welfare (MHLH) has granted manufacturing and marketing approval for the OncoBEAM™ RAS CRC Kit (Sysmex) used for blood-based circulating tumor DNA (ctDNA) molecular testing of mutations in the RAS gene for advanced colorectal cancer patients.
With clinically-validated high sensitivity and specificity for ctDNA molecular characterization and an extensive publication history, the approval of the OncoBEAM RAS CRC Kit marks the first approval of a liquid biopsy test in Japan. The approval will provide CRC patients with a viable alternative to tissue testing. The availability in Japan is expected to greatly improve the management of patients with colorectal cancer.
The availability of the OncoBEAM RAS CRC kit in Japan will reduce the need for invasive tissue biopsy and expedite the delivery of important molecular information required for the accurate prescription of therapy for patients suffering from colorectal cancer.
The test was jointly developed between Sysmex subsidiary Sysmex Inostics and Merck KGaA, Darmstadt, Germany, and received CE Marking* in 2016.
For the approval in Japan, eight facilities were involved in a multi-center evaluation, including the National Cancer Center Hospital East in Kashiwa City, Japan.
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 (Erbitux®; Eli Lilly and Company) in the course of treatment.
In the OncoBEAM RAS CRC Sysmex will launching an OncoBEAM RAS CRC Assay Service which is expected to further widen adoption of precision medicine for Japanese patients.
Sysmex included technologies initially developed by experts at the Johns Hopkins School of Medicine over a decade ago.
*CE = European Conformity, certification mark in European Economic Area.