Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu), Toppan Printing Co., Ltd. (HQ: Tokyo, Japan; President & Representative Director: Shingo Kaneko) and RIKEN GENESIS Co., Ltd. (HQ: Tokyo, Japan; President & CEO; Naoto Kondo) have jointly developed the LW-100 Gene Measurement Analyzer (research use only) and a group of related reagents as a system to fully automate testing to detect gene mutations in cancer tissue.
The three companies began providing this system and will move forward proactively with verification of its clinical utility to standardize gene testing using cancer tissue specimens, in the aim of early commercialization of the system for clinical application.
Overview of the System
Product configuration: |
-LW-100 Gene Measurement Analyzer (research use only) -Dispensing chip -Nucleic acid extraction cartridge -EGFR mutation detection chip (LW-100 EGFR Research Reagent) |
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Launch: | August 2018 | |
Target market: | Japan (research market) | |
Main characteristics: | ||
・Simply insert pathology specimens; the instrument automatically handles nucleic acid extraction, purification, analysis and output of results ・Uses a gene mutation detection chip that can measure multiple assays (up to 23 assays) at once ・Achieves highly sensitive measurement using the BNA clamp PCR method ・Sensitivity: 100 or fewer copies (equates to 0.1%, assuming 105 copies for the entire genome) ・Specimen processing time of 3 hours, 40 minutes for one sample, or 8 hours for three samples |
Product Photos
LW-100 Gene Measurement Analyzer (research use only) |
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Dispensing chip | Nucleic acid extraction cartridge | EGFR mutation detection chip LW-100 EGFR Research Reagent |
Terminology
1 | EGFR gene mutation: The epidermal growth factor receptor (EGFR) is a receptor that handles signal transduction to recognize factors related to cell proliferation. EGFRs exist in numerous cells, but mutations in the genes comprising EGFRs are related to the onset of cancer, as well as cancer infiltration and metastasis. |
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2 | BNA clamp PCR method: BNAs are compounds that have a structure similar to synthetic DNA and form strong bonds to complementary nucleic acids, forming a stable double chain. This BNA quality is used to bond with (clamp) genes other than those being targeted, inhibiting their amplification. In mutation detection, typical PCR has low sensitivity due to background noise from unmutated genes. However, as BNA clamp PCR allows for the selective amplification of only the mutated genes, background noise is curtailed, enabling highly sensitive detection. LW-100 EGFR Research Reagent is manufactured in Japan under a license agreement with RIKEN GENESIS subsidiary BNA Inc. (Japan) (Japanese patent numbers 4731324 and 6242336; corresponding patent applications filed in other countries). EGFR Research Reagent is also protected by US patent number 7294468 and corresponding overseas patents. |