OncoBEAM[TM] EGFR Kit (RUO) at Jessenius Medical Faculty of Comenius University and its University Hospital, in Martin, Slovakia

HAMBURG, Germany, September 26, 2017 /PRNewswire/ --

The launch is the first of its kind and will widen the use of of BEAMing technology in lung cancer area.

Sysmex Inostics, a subsidiary of Sysmex Corporation, a global leader in blood based circulating tumor DNA (ctDNA) analysis and molecular diagnostics for oncology, announces that the OncoBEAM^[TM] EGFR Kit (RUO) is now available in Slovakia's leading medical institution, Jessenius Medical Faculty of Comenius University and its Department of Pathology in University Hospital, Martin, led by renowned Professor Plank.

The OncoBEAM^[TM] EGFR Kit (RUO) is designed to utilize the BEAMing technology platform which is installed globally at hospital laboratories and is widely used to perform RAS mutation detection for colorectal cancer patients with the OncoBEAM^[TM] RAS CRC Kit. BEAMing digital PCR technology employs beads-based amplification in water-in-oil emulsions and allele-specific hybridization followed by flow cytometry. The OncoBEAM^[TM] EGFR Kit (RUO) is a Research Use Only assay for the qualitative detection of EGFR mutations (exon 19, 20 and 21) including T790M in cell-free DNA extracted from plasma. The OncoBEAM^[TM] EGFR Kit (RUO) represents a new standard for the highly sensitive detection of EGFR mutations including sensitizing mutations such as Exon 19 deletions and L858R and the primary EGFR resistance mutations, T790M and C797S.

Professor Lukas Plank remarked, "we are honored that, through our joint-venture with Martin's Biopsy Center Ltd. and after the start with a pilot clinical study using OncoBEAM^[TM] RAS CRC Kit, we now have the privilege to examine plasma EGFR mutations in our lung cancer program with the support of a superb methodology demonstrating high sensitivity and unsurpassed by previously used assays. I am strongly convinced that these tests will substantially contribute to the progress in oncological care of our patients, at the same moment I am deeply proud of the collaboration and proficiency showed by all members of our team."

"This introduction of OncoBEAM^[TM] EGFR (RUO) signals further progress of the contributions BEAMing digital PCR technology continues to make for the oncology field, and I am proud it is serving to improve Slovakia's management and molecular understanding of lung cancer," Mark Kubota, CEO of Sysmex Inostics noted. "Lung cancer is one of the most prevalent cancers in the world, and the high sensitivity of the BEAMing technology can deliver a powerful tool to understand the dynamics of plasma EGFR mutational profiles in relation to lung cancer." Sysmex Inostics plans to offer the OncoBEAM^[TM] EGFR Kit (RUO) to other European and Asian countries.

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 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 cancer patients^[1],[2].  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 BEAMing and Plasma-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 being one of the most sensitive technologies available today^[3] 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. 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' 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 OncoBEAMTM.sysmex-inostics.com or email info@sysmex-inostics.com.

References 

1. Vidal, J. et al. Plasma ctDNA RAS mutation analysis for the diagnosis and treatment monitoring of metastatic colorectal cancer patients. Ann. Oncol. Off. J. Eur. Soc. Med. Oncol. (2017). doi:10.1093/annonc/mdx125

2. Oxnard, G. R. et al. Association Between Plasma Genotyping and Outcomes of Treatment With Osimertinib (AZD9291) in Advanced Non-Small-Cell Lung Cancer. J. Clin. Oncol. Off. J. Am. Soc. Clin. Oncol. 34, 3375-3382 (2016).

3. Diaz, L. A. & Bardelli, A. Liquid biopsies: genotyping circulating tumor DNA. J. Clin. Oncol. Off. J. Am. Soc. Clin. Oncol. 32, 579-586 (2014).

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