Germany-based molecular diagnostic company Sysmex Inostics has introduced its blood-based OncoBEAM in-vitro diagnostics (IVD) test at its radioallergosorbent (RAS) biomarker testing site at the Biopathology department of the Institut de Cancérologie de Lorraine (ICL) in France.
The OncoBEAM IVD test is a non-invasive, quick process to determine RAS test status which is considered important to shape the therapy for RAS wild type metastatic colorectal cancer (mCRC) patients.
The new centre tumour biology unit head Jean-Louis Merlin said: "With the blood-based mutation test we aim at a dramatic reduction of the delay for mutation analysis and therefore accelerated optimized initiation of personalised therapy."
The blood-based test, also referred to as liquid biopsy, acts as an alternative to tumour tissue-based test requiring biopsies or other surgical specimen which is instrumental in the case when determination of RAS mutations in circulating cell-free DNA with the OncoBEAM RAS CRC test is sensitive, requiring a single blood-draw.
This test can be leveraged when there is an absence of the tumour tissue and a quick result is required to facilitate the therapy.
It has demonstrated performance akin to the existing conventional tissue-based testing and can be used to determine which patients are suited to be administered with anti-EGFR therapies, such as Erbitux.
The test includes 34 KRAS and NRAS mutations aligned with the recommendations of the NCCN, ESMO as well as European medicines agency (EMA) guidelines to determine the RAS mutation status before the treatment.
ICL is conducting a multicentre prospective study, under the acronym ColoBEAM, to distinguish the real-life implementation of the OncoBEAM RAS CRC test on blood and the standard test on formalin fixed and paraffin embedded tumour tissue.