News

Development Background
In line with advances in personalized medicine in recent years, the number of cases is growing in which diagnosis and the selection of therapeutic drugs for cancer treatment are being made based on the results of gene testing. Diagnosis guidelines also recommend the use of gene testing.

When selecting post-operative treatment methods for cancer patients, testing is performed to study gene mutations in the cancer tissue resected during surgery. With conventional methods, however, processes such as nucleic acid extraction and gene amplification (PCR) required numerous manual processes, such as the dispensing of samples and reagents. As a result, in many cases the gene testing had to be outsourced to specialized commercial labs, so determining treatment methods took time. The trend toward an early start of treatment calls for in-hospital gene testing and the corresponding standardization of the testing.

Sysmex, Toppan Printing and RIKEN GENESIS entered an alliance in June 2014 aimed at standardizing cancer gene testing. Using Sysmex’s reagent development capabilities and systemization technologies, Toppan Printing’s development technologies of gene mutation detection chip and other consumables, and RIKEN GENESIS’s gene mutation analysis technologies, the companies have pursued joint development of a system to automate gene testing using cancer tissue specimens.

System Features
The system comprises an LW-100 Gene Measurement Analyzer (research use only) and a group of related reagents, including a nucleic acid extraction cartridge and a gene mutation detection chip. The companies have begun launching this system in the research market, providing automated processes including a paraffin solution containing cancer tissue specimens, the extraction and purification of nucleic acid, gene amplification, and the reporting of measurement results.

The system automates the overall testing processes including multiple manual processes, helping to standardize the testing.

Introduced along with the LW-100 is the LW-100 EGFR Research Reagent, a detection chip for the EGFR gene mutation,¹ a major biomarker for lung cancer. The LW-100 EGFR Research Reagent uses the BNA clamp PCR method,² which is employed to amplify the specific gene mutations to be detected and achieves a highly sensitive measurement of EGFR gene mutations.

Future Developments
The companies are introducing the system into the Japanese research market to accelerate initiatives toward commercialization for clinical application and the standardization of gene testing. At the same time, we will form alliances with pharmaceutical companies and medical institutions globally to promote the development of companion diagnostic drugs.

Going forward, Sysmex, Toppan Printing, and RIKEN GENESIS will accelerate initiatives targeting further innovation in gene analysis testing. We also aim to create clinical value in personalized diagnostic technologies toward the selection of treatment methods optimized for individual patients.

 

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)
	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)
Dispensing chip	Nucleic acid extraction cartridge	EGFR mutation detection chip LW-100 EGFR Research Reagent

 

 

 

Terminology