Sysmex Inostics, a subsidiary of Sysmex Corporation, a global leader in blood based circulating tumor DNA (ctDNA) analysis and molecular diagnostics for oncology is pleased to announce new data from a large real-world prospective evaluation of the OncoBEAM™ RAS CRC test for routine clinical use in hospital laboratories across Spain. Sysmex Inostics’ OncoBEAM™ RAS CRC assay was granted CE Mark approval in 2016 as part of a global collaboration with Merck KGaA and is a comprehensive blood-based test which evaluates 34 mutations in KRAS and NRAS (RAS) as recommended by clinical practice guidelines to determine RAS mutation status in metastatic colorectal cancer (mCRC) patients prior to initiation of targeted therapy.
OncoBEAM™ RAS CRC is the only liquid biopsy assay with CE Mark IVD status for plasma RAS mutation analysis and has been installed at a number of certified centers of excellence over the past year. In order to support its clinical adoption, a rigorous real-world evaluation of the performance of OncoBEAM™ RAS CRC in routine use was conducted amongst a consortium of ten preeminent Spanish hospital centers. This prospective performance evaluation compared the RAS mutation results of OncoBEAM™ RAS CRC liquid biopsy testing to tissue testing in a sampling of patients from each hospital.
In this study, over 230 patients were evaluated and the overall concordance of results from plasma and tissue RAS mutation testing was 90.5%, with positive percent agreement of 86.9% and negative percent agreement of 95.1%. In order to provide more insight into discordant cases, tissue was re-analyzed with BEAMing and revealed 2 false negative local tumor tissue RAS results. In patients presenting with isolated peritoneal and/or lung metastases, plasma false negative results were observed more frequently. This confirmed previously reported findings as isolated lung metastases and peritoneal lesions have typically demonstrated a lower likelihood of depositing tumor DNA into peripheral circulation. The overall prevalence of RAS mutations in plasma (51.3%) and tissue (56.5%) matched the expected prevalence of RAS mutations in mCRC patients.
In this first prospective real-world RAS mutation performance comparison study across a network of hospital laboratories certified to perform OncoBEAM™ testing in routine clinical practice, a high overall agreement was observed between results obtained from plasma and tissue samples. Overall, these findings indicate that plasma OncoBEAM™ RAS testing is a viable solution for rapid delivery of RAS mutation status to determine mCRC patient eligibility for anti-EGFR therapy. As lead author, Dr. Jesus Garcia-Foncillas, Director of the Cancer Institute, University Hospital Fundacion Jimenez Diaz, Autonomous University of Madrid remarked, "It is my great pleasure to report these extremely favorable results on behalf of all participating Spanish centers. Since the OncoBEAM platform was installed a little over a year ago, we have been rigorously evaluating its performance to ensure its appropriateness for routine clinical practice. Based on our experience and these recent results, we are enthusiastically supportive of OncoBEAM blood based testing and grateful to have this valuable test available for mCRC patients. OncoBEAM has demonstrated accurate and reliable performance in real-world practice and is a significant benefit to patient care, providing a RAS mutation status results within days, which helps to accelerate treatment decisions for patients with advanced disease."
The highly sensitive OncoBEAM™ RAS CRC test is a simplified method for determining the RAS mutation status of tumors, which requires only a single blood-draw. Thus, the test has the potential to provide mutation status results within days to help guide quicker treatment decisions. Moreover, the blood-based test is an alternative to tissue biopsies or other surgical procedures, and can also be performed when no tumor tissue is available or a rapid test result is crucial for therapy success. The OncoBEAM™ RAS CRC test is available across Europe, China, and Asia Pacific to determine RAS mutation status for newly diagnosed mCRC patients with a simple blood draw in routine clinical practice.
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