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Sysmex Inostics’ OncoBEAM™ Technology highlighted at ASCO 2017 Annual Meeting



Mundelein, IL, 2017.06.28 – 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 highlights of its OncoBEAM™ technology from the American Society of Clinical Oncology’s (ASCO) 2017 annual meeting. Sysmex Inostics’ highly sensitive OncoBEAM™ technology allows for molecular genetic analysis of ctDNA from blood, delivering a highly sensitive and individualized approach to complement clinical care in oncology. Novel clinical applications of OncoBEAM™ in NSCLC and a platform comparison of different ctDNA detection methods were highlighted at the ASCO 2017 annual meeting.

In a comparison of liquid biopsy approaches for RAS mutation detection, Prof. Léa Payen-Gay, co-investigator of the CIRCAN (“CIRculating CANcer”) program at the Hospices Civils de Lyon Laboratory, based in Lyon, France, compared the performance of three different technologies for the detection of ctDNA from lung and colon cancer patients: ddPCR, BEAMing emulsion digital PCR and NGS (abstract e23056). BEAMing was performed with the OncoBEAM™ RAS test which received CE Mark approval in April 2016, and is certified for routine clinical use in Lyon. Results from the platform comparison showed a high level of sensitivity and specificity of OncoBEAM™ for the detection of plasma mutations in the blood of colorectal cancer patients at diagnosis and in non-small-cell lung (NSCLC) patients during tumor progression. Overall the mutation status agreement between plasma and tissue was 96% for colorectal cancer patients at diagnosis and 73% for NSCLC patients during tumor progression. BEAMing detected 11 of 13 RAS mutations (KRAS and NRAS) versus only 5-6 mutations detected by either NGS or ddPCR. OncoBEAM™ also exhibited superior sensitivity at low DNA inputs, with a mutation detection threshold of 0.03% versus 1% for samples tested with ddPCR or NGS. Pr. Payen-Gay said, “BEAMing is clearly advantageous for clinical use where reliability and high sensitivity are valued by patients and oncologists for the accurate prescription of targeted therapy.”

The potential utility of OncoBEAM™ testing in patients with epidermal growth factor receptor (EGFR) T790M mutation-positive NSCLC was also highlighted in an abstract (9018) and presentation at ASCO 2017. Data was presented on patients from the AURA Phase I study who exhibited acquired resistance to prior therapy with an EGFR- tyrosine kinase inhibitor (TKI). Patients were determined to be EGFR T790M mutation-positive at baseline by either tissue or plasma testing and subsequently underwent treatment with osimertinib, a third generation irreversible EGFR-TKI designed to inhibit both EGFR sensitizing and EGFR T790M resistance mutations. Plasma samples from these patients were tested by BEAMing for EGFR sensitizing (Exon 19 deletions, L858R) and EGFR T790M resistance mutations at baseline and at 6 weeks post-osimertinib treatment in order to investigate the impact of dynamic changes in plasma EGFR mutation levels on clinical outcome. At 6 weeks, EGFR mutations were cleared from plasma in 64% of patients (92/143). These patients experienced significantly longer median progression free survival (PFS) of 10.8 months compared to those with detectable plasma EGFR mutations at 6 weeks (PFS: 4.2 months). The overall response rate (ORR) was significantly higher in patients with plasma EGFR mutation clearance (ORR: 74%), versus those patients whose plasma had detectable EGFR mutations at 6 weeks (ORR: 41%). The investigators conclude that the early clearance of plasma EGFR mutations in patients undergoing treatment with osimertinib appears to be a viable prognostic marker that could be used to predict outcomes. Future studies will be needed to confirm these findings. Looking towards the future clinical application of routine plasma EGFR monitoring, Dr. Geoffrey Oxnard of Dana-Farber Cancer Institute, senior author of the abstract said, “Initial plasma genotyping to look for EGFR T790M may be only half the story, as additional information could potentially be gained from retesting on therapy to assess for response and to gain insight into osimertinib resistance.”

About OncoBEAM™
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.

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’ OncoBEAM™ services are readily available to support clinical trials and research in oncology. Furthermore, Sysmex Inostics 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 are located in Mundelein, IL; Sysmex Inostics’ Clinical Laboratory is located in Baltimore, Maryland; Sysmex Inostics’ Service Laboratory is located in Hamburg, Germany. For more information on OncoBEAM™ blood testing and the BEAMing technology refer to www.sysmex-inostics.com or email info@sysmex-inostics.com.

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