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Sysmex Obtains First Manufacturing and Marketing Approval in Japan for Blood-Based RAS Gene Mutation Testing for Colorectal Cancer

Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) has obtained Japanese manufacturing and marketing approval for the OncoBEAM™1 RAS CRC Kit, used for blood-based circulating tumor DNA molecular testing of mutations in the RAS gene2 for colorectal cancer patients. This product is the first in vitro diagnostic reagent in Japan to be used for RAS gene mutation testing for colorectal cancer using liquid biopsy. Minimally invasive and simpler than conventional physical biopsies of tumor tissue, the new testing method provides detection results on a par with the use of tumor tissue.3 As a result, this testing method reduces the physical and mental burden on patients, expands testing opportunities, and contributes to the early-stage determination of treatment methods.

In recent years, demand has grown for the use of liquid biopsy in the diagnosis and selection of treatment methods for cancer and other diseases. Liquid biopsy refers to using blood or other bodily fluids, which place little burden on the patient, rather than physical biopsies, which require taking samples of a cancer tumor or other tissue.4 Sysmex has defined the “resolution of medical issues through products and services” as one of the priority issues (materiality) for realizing a sustainable society and sustainable growth in corporate value for Sysmex through the creation of new technologies and markets. As one aspect of these activities, Sysmex is pursuing R&D toward the realization of personalized medicine, which involves the provision of healthcare optimized for individual patients, and the proliferation of testing to reduce the physical burden on patients.
 
The OncoBEAM™ RAS CRC Kit is used to test samples of tumor-derived DNA (circulating tumor DNA, or ctDNA) suspended in the blood of colorectal cancer patients. To help doctors determine treatment methods, this product provides auxiliary test data to determine the appropriateness for patients with colorectal cancer of the molecularly targeted drags—Cetuximab and Panitumumab (gene recombination)—, using BEAMing technology5 that detects RAS gene mutations to a high degree of sensitivity. Jointly developed between Merck KGaA, Darmstadt, Germany, and our subsidiary Sysmex Inostics, the product received CE Marking certification in March 2016, which indicates the product complies with the European IVD Directive, and is already being used for clinical applications in Europe. For the approval as an in vitro diagnostic reagent in Japan, eight medical facilities were involved in a multi-facility evaluation, including the National Cancer Center Hospital East. Gene testing using this product can be used to provide appropriate treatment opportunities for patients that would have difficulty with testing using conventional tumor tissue. Furthermore, rather than physical biopsies, this type of testing allows samples to be obtained from blood samples in a simple and minimally invasive manner. This helps reduce the physical and mental burden on the patient, shortens the time required from the start of testing, and contributes to the early-stage determination of treatment methods. 
 
Going forward, we plan to launch the OncoBEAM™ RAS CRC Assay Service, an assay service for colorectal cancer using liquid biopsy to detect RAS gene mutations in the blood, at the Sysmex IMP laboratory, located in the Kobe Biomedical Innovation Cluster. To increase the opportunities for more patients to receive the testing, we plan to apply for Japan’s national insurance coverage for this product. 
 
By providing new cancer diagnostic methods to patients at the earliest possible date, such as the OncoBEAM™ RAS CRC Kit, as well as the OncoGuideTM NCC Oncopanel System,5 which received insurance coverage in Japan on June 1, 2019 for use in cancer genome profiling, Sysmex aims to take the global lead in realizing personalized medicine, contributing to patient quality of life and the advancement of healthcare. 


Product Overview
OncoBEAM™ RAS CRC Kit

  Name: OncoBEAM™ RAS CRC Kit
  Use: To detect RAS (KRAS and NRAS) gene mutations in genomic DNA extracted from plasma
(Auxiliary use to determine the appropriateness of Cetuximab and Panitumumab (gene recombination) for patients with colorectal cancer)
  Target market: Japan
  Target institutions: Healthcare institutions and clinical testing centers in Japan, other
  In vitro diagnostics manufacturing and marketing approval number: 30100EZX00010000 (Obtained on July 19, 2019)

Reference

 
April 6, 2016 press release entitled “New Liquid Biopsy RAS Testing for metastatic colorectal cancer patients now available for clinical practices”
 
 
 Terminology
  ※1
OncoBEAM™: 
The name of Sysmex’s technology to detect minute gene mutations circulating in the blood with a high degree of sensitivity using BEAMing technology. BEAMing technology is an acronym for “bead, emulsion, amplification and magnetics”, a gene analysis method developed at Johns Hopkins University combining digital PCR and flow cytometry technologies for highly sensitive analysis of genetic mutations.
 
  ※2
RAS gene:
As the likelihood is high that patients with RAS gene (KRAS/NRAS gene) mutations will not benefit (prolongation of life, tumor reduction) from the administration of anti-EGFR drugs, companion diagnostics may be performed to treat the gene mutation first. 
 
  ※3 
According to the results of multi-facility evaluation, determination results using this method are on a par with those of conventional RAS gene mutation testing using tumor tissue. Source: British Journal of Cancer volume 120, pages 982–986 (2019)
 
  ※4
The Guidance on Genetic Testing in the Treatment of Coloretal Cancer Vol. 4.1 (May 2019), published by the Japanese Society of Medical Oncology, indicates the necessity of using liquid biopsy for colorectal cancer and the clinical utility of ctDNA testing. 
 
  ※5 OncoGuide™ NCC Oncopanel System (medical device manufacturing and marketing approval No.:23000BZX00398000):
(Reference) May 31, 2019 press release entitled “The OncoGuide™ NCC Oncopanel System Receives Insurance Coverage for Use in Cancer Genome Profiling” https://www.sysmex.co.jp/en/news/2019/190531.html
 
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    but may be subject to change without prior notice.

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