Contributing to improvement of the accuracy of highly sensitive genetic testing using blood.
Schematic diagram of cell-free DNA in blood of lung cancer patient
Personalized medicine is beginning to be used more widely as a means of discovering and treating cancer. This is a type of precision medicine in which the genes in patient's cancer tissue are tested to predict the effects of therapeutic agents. Genetic testing investigates mutations in genes that are related to oncogenic transformation and the effects of therapeutic agents against cancer. In genetic testing for lung cancer, a number of therapeutic agents (molecularly targeted drugs*3) tailored to changes (mutations) in genes have been developed and have come into practical application early on.
The EGFR (Epidermal Growth Factor Receptor) gene*4 test is one of the typical genetic tests related to lung cancer.
When patients are considering pharmacotherapy for lung cancer, they are tested for EGFR-activating mutants in order to decide upon a therapeutic agent. They are also tested for EGFR-resistant mutants in order to investigate what kinds of drug resistance might develop after administration of the therapeutic agent. Methods such as PCR*5 and NGS (next-generation sequencing)*6 are used in these kinds of genetic testing.
The samples used in genetic testing of lung cancer consist of resected tissue harvested during surgery or tissue harvested with a bronchoscope (biopsy), but these methods of harvesting are invasive and impose a heavy burden on the body of the patient. In recent years, attention has been focused on the liquid biopsy,*7 which reduces the burden on the patient by using blood, which can be harvested with minimal invasiveness.
'EGFR Liquid',*8 developed by
'RICOH Standard DNA Series' is a family of products based on reference DNA plate technology, which uses Ricoh's own bioprinting technology to dispense a prespecified number of DNA molecules in 1-molecule units, so that accuracy control and quality control of genetic testing equipment, genetic testing methods, and reagents can be performed rigorously even in the low-concentration area with fewer than 100 molecules, where variation tends to develop if dilution is performed by hand.
Ricoh developed 'RICOH Standard DNA Series EGFR mutation Type001', a reference material for confirming the accuracy of genetic testing as a model for the cell-free DNA in the blood of lung cancer patients. The number of cancer cell-derived cell-free DNA molecules in the blood differs from one patient to another, but in over half of patients, there are fewer than 100 molecules with EGFR-activating mutants in the blood sampled for one test, and the number of resistant mutants is even smaller (according to an investigation by
*This product is a reagent for research use only.*1 Reference DNA plateReference DNA plate is the result of joint research by
https://www.ricoh.com/release/2018/0604_1.html*3 Molecularly targeted drugA therapeutic agent that exerts its effect by attacking specific molecules that are peculiar to cancer cells in a targeted manner.*4 EGFR (Epidermal Growth Factor Receptor) geneEGFR gene mutations are found in approximately 30% of lung cancer patients. They are the most frequently found mutation in lung cancer patients, and tends of thousands of tests for these mutations are performed annually.*5 PCR methodA DNA amplification method using the Polymerase Chain Reaction.*6 NGS.An abbreviation for Next Generation Sequencing. This is a method that can simultaneously read multiple DNA sequences.*7 Liquid biopsyTest using blood or other body fluids, mainly to diagnose and treat cancer.*8 'EGFR Liquid', developed by DNA Chip ResearchOfficial name: 'EGFR Liquid' Gene Analysis Software
A test that can be used in liquid biopsies, developed with the aim of performing EGFR gene testing in a minimally invasive manner (can use both tissue and blood). Application for regulatory approval submitted in
ANNOUNCEMENT OF SPECIALLY-CONTROLLED MEDICAL DEVICE MANUFACTURING AND SALES APPROVAL FOR THE 'EGFR Liquid' GENE ANALYSIS SOFTWARE, AS A DISEASE DIAGNOSIS PROGRAM.
https://www.dna-chip.co.jp/en/common/press_en_148.pdf*9 Allele frequencyRatio of mutant DNA to non-mutant DNA
Relevant Information
(News Release) RICOH launches RICOH Standard DNA Series of reference DNA plates that overcome challenges in PCR testing
(News Release) Bioprinting Technology to Control the Number of DNA Molecules in Units of One
(Technical page) The Manufacturing of reference DNA plates
News release in PDF format
Reference DNA plate for genetic testing in lung cancer Launch of RICOH Standard DNA Series EGFR mutation Type001 (5pages/248KB)
For further information, please contact:
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Healthcare Business Groupstandard_dna_series@jp.ricoh.comPublic Relationskoho@ricoh.co.jp
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Minato-ku,
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