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.
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)
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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) |
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April 6, 2016 press release entitled “New Liquid Biopsy RAS Testing for metastatic colorectal cancer patients now available for clinical practices”
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※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.
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※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.
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※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)
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※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.
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※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 |