Hamburg, Germany, 2018.01.16 – Sysmex Inostics, a global leader in blood based circulating tumor DNA (ctDNA) analysis and molecular diagnostics for oncology, today announces data from an abstract of a study comparing the performance of plasma RAS mutation detection by two commercial liquid biopsy testing platforms, OncoBEAM RAS CRC and Idylla ctKRAS Mutation Test. The results of this study will be presented at the American Society of Clinical Oncology’s Gastrointestinal Cancer Symposium ASCO GI on January 20 in San Francisco, CA.
In this study, conducted by a group of four leading Spanish hospitals that perform liquid biopsy testing in routine colorectal cancer (CRC) clinical practice, investigators found significant differences in clinical sensitivity for KRAS mutation detection between OncoBEAM and Idylla. Specifically, OncoBEAM demonstrated significantly greater sensitivity for detection of plasma KRAS mutations than Idylla. The investigators identified a “gray zone” below 1% Mutant Allele Fraction (MAF) where OncoBEAM reliably detected KRAS mutations in patient plasma samples, but Idylla did not.
As Dr. Ana Vivancos, Principal Investigator, Cancer Genomics Group at Vall d’Hebron Institute of Oncology (VHIO) in Barcelona commented on the findings, “Importantly, these results show a gray area where real-time PCR based assays like Idylla show reduced KRAS mutation detection accuracy in plasma as compared to tissue testing and digital PCR testing with OncoBEAM. This should serve as a reminder that not all liquid biopsy assays are equivalent and clinicians and molecular biologists need to be aware that assays lacking appropriate sensitivity may result in diminished precision to guide targeted therapy.”
Additional information on poster details can be found below and can be accessed at https://www.asco.org/2018-gastrointestinal-cancers-symposium.
Presentation Details (all times local):
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 sensitivity 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 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 a proprietary Plasma-Sequencing approach. 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 being one of the most sensitive technologies available today for the detection of tumor specific somatic mutations in blood samples, Sysmex Inostics’ OncoBEAM™ services are readily available to support clinical trials and research in oncology. Furthermore, Sysmex companion diagnostics (CDx) team offers services for the development of non-invasive cell-free DNA-based IVD tests supported by a growing network of partners to cover the entire IVD development process. In addition, OncoBEAM™ tests are available through a CLIA certified laboratory for routine clinical analysis.
Sysmex Inostics’ headquarters and GCP Service Laboratory are located in Hamburg Germany; Sysmex Inostics’ CLIA certified and GCP Clinical Laboratory is located in Baltimore, Maryland; Sysmex Inostics’ Commercial Offices are located in Mundelein, IL. For more information on OncoBEAM™ blood testing and the BEAMing technology refer to www.sysmex-inostics.com or email email@example.com.