Hamburg, Germany, 2018.09.27 – Sysmex Inostics, a subsidiary of Sysmex Corporation and a global leader in blood-based circulating tumor DNA (ctDNA) analysis and molecular diagnostics for oncology, announces the launch of the OncoBEAM™ EGFR Kit v2 for research use only in Europe and Asia. OncoBEAM™ EGFR Kit v2 replaces the EGFR v1 kit and joins Sysmex Inostics’ OncoBEAM™ RAS CRC and BRAF assays which enable laboratories to perform highly sensitive ctDNA analysis of colon and non-small cell lung cancer samples. OncoBEAM™ EGFR v2 covers substantially more mutations in the epidermal growth factor receptor (EGFR) gene than its predecessor.
The OncoBEAM™ EGFR Kit v2 also features workflow improvements over the previous version. For example, it includes an internal quantifier to eliminate up-front DNA quantification steps, which decreases the amount of hands-on sample processing. Increased run flexibility (three to ten samples per run) enables the laboratory to improve the efficiency of reagent use, as well as to test smaller and larger batch sizes which accelerates testing and better accommodates laboratories with variable daily throughput. Together, these improvements enable shortened turnaround time as a native feature of the new kit.
The OncoBEAM™ EGFR Kit v2 employs BEAMing technology to detect thirty-six cancer-relevant EGFR mutations present in ctDNA extracted from plasma including sensitizing mutations such as exon 19 deletions and L858R, as well as the T790M resistance mutation and multiple C797S variants. The OncoBEAM assay combines emulsion-based PCR with flow cytometry to deliver ultra-sensitive detection of rare mutant molecules. The analytical and workflow enhancements of the OncoBEAM™ EGFR Kit v2 represent the most advanced BEAMing kit available to-date, resulting in exceptionally high-sensitivity blood-based detection of EGFR mutations. This assay utilizes a minimum of two milliliters of plasma to rapidly deliver a more comprehensive view of EGFR mutation status across all tumor cells compared to single-site tumor tissue testing. Additionally, the sensitivity of OncoBEAM™ for rare mutant molecule detection has been shown to exceed that of other methodologies including traditional next-generation sequencing (NGS) panels that lack the analytical optimization required for reliable detection of ctDNA.
Initial installments of OncoBEAM™ EGFR v2 in Centers of Excellence in Spain, Slovakia, and France have confirmed the improved workflow features and enhanced assay performance within multiple laboratories. In coming months, the assay will be widely available across Europe and Asia. As Professor Lukas Plank, head of the Department of Pathology at the Martin University Hospital in Slovakia commented, “The highly sensitive detection of OncoBEAM™ EGFR assay enables us to distinguish mutations in blood samples that would be extremely challenging or not possible with other methods. The availability of the v2 kit greatly improves the workflow implementation in our laboratory and provides greater flexibility for processing a minimum sample number to assist in optimizing turnaround time to results.”
Disclaimer: The OncoBEAM™ EGFR Kit v2 is for research use only. Any in vitro diagnostics purpose has not been established by the manufacturer.
Sysmex Inostics’ highly sensitive OncoBEAM™ services allow for molecular genetic analysis of cell-free tumor DNA from blood or plasma, delivering an individualized approach to complement treatment decision-making in oncology. Based on the highly sensitive BEAMing technology developed at the Johns Hopkins University School of Medicine, OncoBEAM™ testing is able to provide multiplex hotspot mutation analysis for the accurate and reliable detection of rare mutant molecules of tumor DNA from blood samples of patients with cancer. Due to its minimal-invasive nature, OncoBEAM™ delivers new possibilities for cancer management while minimizing costs and risks inherent with tissue biopsies. The OncoBEAM™ assays target a wide variety of clinically actionable genetic mutations in various cancers like melanoma, colorectal, breast and lung cancer, delivering information in real-time to support therapy selection, detection of emergent mutations and assessment of drug response. In the US, OncoBEAM™ tests are available as GCP and CLIA services. OncoBEAM™ RAS CRC CE IVD kit is available in EU.
About Sysmex Inostics
Sysmex Inostics, a subsidiary of Sysmex Corporation, is a molecular diagnostic company whose core competency is mutation detection utilizing highly sensitive technologies such as BEAMing and Plasma Safe-Sequencing. Sysmex Inostics is a trusted partner to leading pharmaceutical companies, advancing their efforts to bring the most effective personalized cancer therapies to global markets.
With BEAMing and Plasma Safe-Sequencing (SafeSeq) being some of the most sensitive technologies available today for the detection of tumor-specific somatic mutations in blood samples, Sysmex Inostics’ services are readily available to support clinical trials and research in oncology. In addition, OncoBEAM™ tests are available today through a CLIA-certified laboratory for routine clinical analysis.
Sysmex Inostics’ headquarters and GCP Service Laboratory are located in Hamburg Germany; Sysmex Inostics’ Commercial Offices and CLIA-certified and GCP Clinical Laboratory is located in Baltimore, Maryland. For more information on Plasma Safe-Sequencing and OncoBEAM™ blood testing, please visit www.sysmex-inostics.com or email firstname.lastname@example.org