OncoBEAM RAS CRC test awarded CE mark approval in the EU as a diagnostic for metastatic colorectal cancer- Sysmex Corps

Sysmex Inostics, a subsidiary of Sysmex Corporation, announced that its OncoBEAM RAS CRC test has been granted CE Mark approval. The test, developed by Sysmex Inostics GmbH in collaboration with Merck, can now be accessed by patients with metastatic colorectal cancer (mCRC) across Europe. The OncoBEAM RAS CRC assay has been shown to have similar performance to conventional tissue-based testing and can be used to determine which patients would benefit from anti-EGFR therapies, such as Erbitux, as demonstrated by recent data.

The OncoBEAM RAS assay is a comprehensive test which includes 34 KRAS and NRAS mutations reflecting the recommendations of the NCCN, ESMO as well as EMA guidelines to determine the RAS mutation status before initiating treatment. It is expected to be widely implemented across Europe, Asia, Latin America, and Australia by the end of 2016.