TOKYO, August 20, 2020 – Ricoh Company., Ltd. (President and CEO Yoshinori Yamashita) and DNA Chip Research Inc. (President Ryo Matoba) announced that today they will launch “RICOH Standard DNA Series EGFR mutation Type001”, a reference DNA plate*1 jointly developed as reference material*2 for use in accuracy control of bloodbased genetic testing for lung cancer. This product contributes to improving the accuracy of testing by making it possible to confirm the accuracy of highly sensitive genetic testing that detects the very small amounts of DNA molecules from cancer cells that are contained in blood from lung cancer patients. Currently, these are only available in Japan.
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 DNA Chip Research, is a minimally invasive testing method that uses blood, and it makes it possible to perform highly sensitive genetic testing by the NGS method. Cell-free DNA (cfDNA) released by various cells is present in the harvested blood, but most of it comes from normal cells. This test can detect the EGFR-activating mutants that locate on small amounts of circulating tumor DNA (ctDNA), together with the even less common resistant mutants.
“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 DNA Chip Research). “RICOH Standard DNA Series EGFR mutation Type001” was modeled on this, with 10 to 100 cancer cell–derived DNA molecules (including genetic sequences of both EGFR-activating mutants and resistant mutants) per 10,000 normal DNA molecules, dispensed into each well of 8 tubes, so it is expected that this product will be used as a reference material with a mutant allele frequency*9 of 0.1% to 1% in the evaluation of testing systems at medical institutions, testing centers, and research institutes that perform lung cancer testing. We aim to contribute to making precision medicine more accurate and improving the efficacy of treatments for lung cancer by providing this product for use in the confirmation of test accuracy in advance.
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Headquartered in Tokyo, Ricoh Group operates in approximately 200 countries and regions. In the financial year ended March 2019, Ricoh Group had worldwide sales of 2,013 billion yen (approx. 18.1 billion USD).
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