Expert Taskforce Recommendation of OncoBEAMtm RAS CRC Liquid Biopsy Testing in Routine Clinical Practice for Colorectal Cancer Patients

HAMBURG, Germany, November 21, 2017 /PRNewswire/ --

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 highlight an expert taskforce review of the incorporation of BEAMing technology liquid biopsy testing in routine clinical practice for the management of colorectal cancer (CRC) patients. Sysmex Inostics launched the OncoBEAMtm RAS CRC CE Mark IVD Kit in 2016 as part of a global collaboration with Merck KGaA. OncoBEAMtm RAS CRC 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.

OncoBEAMtm RAS CRC is the only liquid biopsy assay with CE Mark IVD status for blood-based RAS mutation analysis and has been installed globally (outside of the U.S.) at certified centers of excellence. Featured in the Annals of Oncology (Open Access available) , an expert taskforce comprised of leading colorectal oncologists and a molecular biologist in Spain highlight the latest clinical and laboratory performance data of OncoBEAM RAS CRC testing and make a recommendation for its incorporation into routine clinical practice. In several head to head studies, blood-based testing with OncoBEAMtm RAS CRC has demonstrated high concordance with tissue-based RAS testing methods. The taskforce reviewed one such large performance evaluation from six centers in Europe which showed overall concordance of 93.3% between OncoBEAMtm RAS CRC testing and standard of care tissue testing for 238 patients. Plasma RAS mutations were found in 112/121 RAS mutant cases determined by tissue-based testing (92.6% positive percent agreement) and no RAS mutations were found in 110/117 cases for which no mutation was detected by tissue testing (94% negative percent agreement). This data references the OncoBEAMtm RAS CRC Instructions for Use (IFU). This robust performance of OncoBEAM testing may be attributed to its highly sensitive detection of ctDNA, as Dr. Emilo Alba, Director UGC Oncología Integral, Regional University Hospital Virgen de la Victoria in Málaga, acknowledged: "Nowadays, the most sensitive technique to detect cell-free tumor DNA is BEAMing; which implies multiple utilities such as the detection of minimal residual disease (MRD) or the monitoring of patients."

The expert taskforce highlighted clinical challenges of CRC patient management that can be significantly improved with the highly sensitive blood-based testing provided by OncoBEAMtm RAS CRC. A key benefit of blood-based RAS testing is the rapid time to results as compared to tissue based testing, aiding the clinician in delivering treatment within a timely manner. Further, the minimally invasive nature of plasma testing can eliminate the need for repeat biopsies in patients with recurrent metastatic disease. As the authors review the clinical challenge of analyzing archival tissue which may not be representative of a patient's current tumor mutational status, the benefit of a blood-based systemic assessment can be realized in the setting of recurrent and metastatic disease where molecular heterogeneity among primary and metastatic sites can challenge the clinician. Dr. Ana Vivancos, Principal Investigator, Cancer Genomics Group at Vall d'Hebron Institute of Oncology (VHIO) in Barcelona remarked, "The liquid biopsy allows us to work with a sample that contains accurate information in real-time about what is happening in the patient's disease, preventing the patient from having to undergo a traditional biopsy." In their review, the expert taskforce supports performing a systemic assessment of tumor mutational status with OncoBEAMtm RAS CRC testing to overcome limitations of single site biopsies in order to aid the clinician to more precisely guide targeted systemic therapy.

The expert taskforce review concludes that the high degree of concordance of RAS testing results generated by blood-based OncoBEAMtm RAS CRC versus standard tissue testing methods supports the use of BEAMing to detect RAS mutations as a replacement to tumor tissue testing. Moreover, the incorporation of the OncoBEAMtm RAS CRC into clinical practice can deliver improved precision to routine care and provide cost-effective management by individualizing treatment plans for CRC patients. Dr. Jesus Garcia-Foncillas, Director of the Cancer Institute, University Hospital Fundacion Jimenez Diaz, Autonomous University of Madrid summarized the clinical utility of OncoBEAM blood-based testing as he remarked, "The results we are achieving with the OncoBEAM platform help us to make decisions that are critical for the patient. Both in the determination of RAS and EGFR mutations, we have the possibility of choosing which therapeutic alternatives that are available have the greatest benefit for each patient. Therefore, this platform allows us to make decisions both in colon and lung cancer specific to each patient."

Reference:  

García-Foncillas, J., Alba, E., Aranda, E., Díaz-Rubio, E., López-López, R., Tabernero, J., Vivancos, A., 2017. Incorporating BEAMing technology as a liquid biopsy into clinical practice for the management of colorectal cancer patients: an expert taskforce review. Ann. Oncol. doi:10.1093/annonc/mdx501

Expert Taskforce: 

• J. Garcia-Foncillas - Cancer Institute, University Hospital Fundacion Jimenez Diaz, Autonomous University, Madrid, Spain
• E. Alba - Medical Oncology Unit, Regional University Hospital Virgen de la Victoria, IBIMA, Malaga, Spain
• E. Aranda - Biomedical Research Institute (IMIBIC), Hospital Reina Sof?a, Faculty of Medicine, Universidad de Córdoba, Córdoba, Spain (CIBERONC)
• E. Diaz-Rubio - Vice President of Royal Spanish Academy of Medicine (RANM) Professor Emeritus Chief of the Cancer Translational Unit Hospital Clínico San Carlos University Complutense Madrid, Madrid, Spain (CIBERONC)
• R. Lopez-Lopez  - Medical Oncology Department and Translational Medical Oncology Group, University Clinical Hospital & Health Research Institute (IDIS); CIBERONC, Santiago de Compostela, University School of Medicine, Santiago de Compostela, Spain
• J. Tabernero - Medical Oncology, Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Universitat Autònoma de Barcelona (UAM), Barcelona, Spain (CIBERONC)
• A. Vivancos - Vall d'Hebron Institute of Oncology (VHIO), Cancer Genomics Lab., Barcelona, Spain

About OncoBEAMtm 

Sysmex Inostics highly sensitive OncoBEAMtm 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, OncoBEAMtm 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, OncoBEAMtm delivers new possibilities for cancer management while minimizing costs and risks inherent with tissue biopsies. The OncoBEAMtm 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 U.S., OncoBEAMtm tests are only available through the service laboratory tests. OncoBEAMtm 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 Plasma-Sequencing and BEAMing. 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' OncoBEAMtm 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, OncoBEAMtm 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 OncoBEAMtm blood testing and the BEAMing technology refer to http://www.sysmex-inostics.com or email [email protected]

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