HAMBURG, Germany, April 11, 2018 /PRNewswire/ --
Colorectal cancer patients in Germany insured by BARMER are now covered for the OncoBEAM RAS CRC IVD Test, an innovative liquid biopsy diagnostic that delivers a comprehensive evaluation of RAS mutations from a single tube of blood. This reimbursement option marks an important milestone in the modernization of oncology care, granting patients access to critical information for timely selection of the most appropriate therapy.
Diagnostic options for cancer therapy
Until recently, therapy selection for cancer patients was based exclusively on standard-of-care tissue analysis. However, various shortcomings exist for this practice, most critically the inability of a single tissue biopsy obtained from a single location to capture the full picture of a dynamic, heterogeneous disease that affects multiple sites. To overcome these limitations, OncoBEAM RAS CRC testing uses state-of-the-art liquid biopsy technology to determine current mutational status for advanced colorectal cancer patients. By analyzing circulating tumor DNA (ctDNA) present in the blood stream, the OncoBEAM RAS CRC test provides more complete genetic information while reducing the need for traditional invasive biopsy procedures.
Precision therapy through liquid biopsy
Establishment of clinical evidence has increasingly supported the use of ctDNA analysis for important medical decision-making, such as selection of targeted therapies. In addition to providing a more complete genomic picture while avoiding the inherent surgical risks of tissue biopsy, Sysmex Inostics' OncoBEAM™ RAS CRC IVD test exhibits high sensitivity for the accurate detection of resistance mutations which emerge over the course of treatment. The test is currently being explored in clinical investigations to determine utility for patient monitoring.
Innovative cancer diagnostics take center stage
In 2017, the American Association for Cancer Research (AACR) awarded Dr. Bert Vogelstein of Johns Hopkins University in Baltimore, as well as Professor Hartmut Juhl, M.D., CEO of Indivumed GmbH in Hamburg, Germany, the AACR Team Science Award for the translation of research discoveries into the oncology clinic. The principle of liquid biopsy, which established the foundation for OncoBEAM technology, originated from scientific collaboration between Vogelstein and Juhl.
"The first global reimbursement for innovative diagnostics for colon cancer patients demonstrates that Germany can be a front-runner in terms of granting access to innovative diagnostic processes," says Juhl. Professor Jan Kramer, M.D., Clinical Manger of the LADR central laboratory, which is certified as an OncoBEAM Center of Excellence, adds, "In the context of routine care, we are delighted to be able to contribute to a significant innovation in patient care through the national logistical availability with our partner company, Intermed, and our accredited laboratory."
Dr. Mani Rafii, Board Member at BARMER, says: "For the use of the new BEAMing technology, it's important to us that the method delivers the highest sensitivity and reliability and is used by specialists with significant experience using it." Frank Liedtke, national CEO of BARMER in Hamburg, further emphasizes the role of insurers in today's healthcare system: "As a health insurer, it is crucial to us that, especially in such a serious condition such as colon cancer, we facilitate personalized therapy with the latest methods and use the innovations from cancer research as soon as possible for the benefit of our patients."
Sysmex Inostics' highly sensitive OncoBEAM™ assays 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 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 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 firstname.lastname@example.org
SOURCE Sysmex Inostics GmbH