Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) has commenced its OncoBEAM™ lab assay services (for research) in Japan, adding to those already offered in Germany and the United States, using BEAMing technology1 to analyze genetic mutations in cell-free tumor DNA circulating in the blood (circulating tumor DNA, or “ctDNA”). Sysmex will provide this service at the Sysmex IMP laboratory it has set up on Port Island (Chuo-ku, Kobe), the site of the Kobe Biomedical Innovation Cluster.
In recent years, demand has grown for the use of liquid biopsy in the diagnosis of, 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. Within the category of liquid biopsy, ctDNA mutation analysis is considered a useful index for predicting the efficacy of molecularly targeted drugs2, and for monitoring drug resistance, and for other diagnostic use. Expectations are high for the rapid establishment of the clinical utility and practical application of this analysis to clinical testing.
Sysmex has been focusing on the development of liquid biopsy with a view to personalized medicine, and acquired Inostics (now Sysmex Inostics) in 2013, with its related technology. To date, regarding the detection of tiny amounts of ctDNA in the blood using BEAMing technology, Sysmex Inostics have conducted clinical research with numerous research institutions, universities and medical institutions, as well as clinical studies with pharmaceutical companies for the development of molecularly targeted drugs. Abundant clinical evidence has been amassed in the process. Sysmex Inostics has bases in Germany and the United States, through which we have provided OncoBEAM™ lab assay services to Japanese research institutions and universities. However, it has become desirable to create a lab assay service structure within Japan itself to meet demand to simplify specimen transport and shorten the time required to report results.
At the Sysmex IMP laboratory, which Sysmex established within the ITOCHU Medical Plaza (IMP) on Port Island in Chuo-ku, Kobe, the site of the Kobe Biomedical Innovation Cluster, the Company has begun collaborating with Sysmex Inostics to offer OncoBEAM™ lab assay services (for research) using BEAMing technology to analyze ctDNA mutations. We began providing these services, targeting research institutions, universities, medical institutions and pharmaceutical companies on December 8, 2017. As a result, we expect to reduce the burden of specimen transport for customers in Japan, and report results more quickly.
We will begin with EGFR gene mutation3 as a target parameter and sequentially expand the number going forward. In recent years, EGFR gene mutation has been focused on as an important biomarker for the increasingly active development of molecularly targeted drugs in relation to lung cancer.
By creating a structure in which the Sysmex Group can provide lab assay services globally, we plan to accumulate clinical evidence on ctDNA gene mutation analysis using BEAMing technology on a global basis, thereby promoting the practical application of testing using liquid biopsy.
Going forward, Sysmex will continue working to develop and promote high-value testing that will contribute to improvements in QOL for patients, the standardization of medical services, and the development of personalized medicine.
Press release dated October 2, 2014, entitled “Sysmex to Establish New Japanese Base within IMP on Kobe Port Island to Develop Companion Diagnostics Drugs toward the Realization of Personalized Medicine”
An acronym for “Bead, Emulsion, Amplification, and Magnetics,” this gene analysis method combines digital PCR (ultrahigh-sensitivity PCR) and flow cytometry technologies for the highly sensitive blood-based detection of minute genetic mutations.
||Molecularly targeted drug:
A drug created to target only certain types of molecules (proteins). Most such drugs are developed and marketed in the field of cancer and are used to control the activity of the protein responsible for tumorigenic transformation.
||EGFR gene mutation:
An acronym for epidermal growth factor receptor, EGFR refers to the receptor that signals by recognizing factors related to cell proliferation. EGFRs are present in various cells, but mutations in the genes that make up EGFRs can lead to the development of cancer, as well as cancer infiltration and metastasis.
- Information contained in the press release is current as of the date of the announcement,
but may be subject to change without prior notice.