Sysmex Inostics, a subsidiary of Sysmex Corporation, announced its first RAS biomarker testing site in France opening at the Biopathology department of the Institut de Cancérologie de Lorraine (ICL), Nancy. The center will offer Sysmex Inostics blood-based OncoBEAM IVD test, developed by Sysmex Inostics GmbH in collaboration with Merck, which is a non-invasive, fast method to determine the RAS status crucial for therapy planning of RAS wild type mCRC patients.
"With the blood-based mutation test we aim at a dramatic reduction of the delay for mutation analysis and therefore accelerated optimized initiation of personalized therapy ", says Prof. Jean-Louis Merlin, head of the Tumor biology Unit of the new center.
Determining RAS mutations in circulating cell-free DNA with the OncoBEAM RAS CRC test is highly sensitive, and only requires a single blood-draw. Thus, the blood-based test, also called liquid biopsy, represent an alternative to tumor tissue-based test that requires biopsies or other surgical specimen. This test can also be performed when no tumor tissue is available or when reducing the delay for providing the result is crucial for therapy success. 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. The certification of conformity with the European harmonized directives (CE-labelling) has been granted in April 2016 allowing its use in routine for patient diagnosis.
As of April 2016, and under the acronym "ColoBEAM", the ICL is conducting a multicenter prospective study comparing the implementation in real-life clinical practice of OncoBEAM RAS CRC test on blood to standard test on formalin fixed and paraffin embedded tumor tissue.
OncoBEAM is a registered trademark of Sysmex Corporation. OncoBEAM is distributed and marketed by Sysmex Inostics, Hamburg, Germany.