Japanese global technology giant Ricoh and DNA microarray developer DNA Chip Research Laboratories created a DNA standard plate for blood-based genetic testing of lung cancer. Launched exclusively in Japan on August 20, 2020, the new Ricoh Standard DNA Series EGFR mutation Type001 is expected to help improve the accuracy of genetic tests that detect small amounts of cancer cell-derived DNA in blood. The new plate is part of the Ricoh Standard DNA Series, a family of products launched in April that uses the company’s own proprietary bioprinting technology to dispense a prespecified number of DNA molecules into containers for accuracy and quality control of genetic testing equipment and methods.
Ricoh’s research reagent is a novel quality control approach for mutation detection in the lung cancer EGFR (Epidermal Growth Factor Receptor) gene and aims to improve precision medicine and the efficacy of treatments for lung cancer by confirming the accuracy of genetic testing. At 70,000 Yen ($660), the 8-tube strip reference DNA plate will allow scientists to visualize the accuracy of the inspection system itself, not the sample. Expected to be used only for research – as it currently cannot be applied for clinical or diagnostic purposes – Ricoh is targeting medical institutions, testing centers, and research facilities that perform lung cancer testing.
Ricoh Standard DNA Series EGFR mutation Type001 developed by Ricoh and DNA Chip Research Laboratories. (Image courtesy of Ricoh)
As cancer continues to be among the leading causes of death worldwide, killing over 9 million people every year, it has become clear that the traditional overly simplified model for cancer therapy is ineffective. Instead, the growing role of personalized and precision medicine over the last decade fostered the development of specialized treatments for each specific subtype of cancer, based on the measurement and manipulation of key patient genetic data. New testing methods have allowed disease prediction based on genetic mutation, as well as the development of individualized health care, both preventive and responsive, as a consequence of a patient’s own genetic features. New research tools, like Ricoh’s Standard DNA Series and the new plate, will help researchers advance the field of genetic testing towards a fully customized healthcare experience.
Normally, genetic testing for cancer requires a biopsy to acquire cancer tissue, a painful operation that is physically invasive. However, according to Tokyo-based DNA Chip Research Laboratories, detecting mutations in genes that are related to the formation of cancer cells became possible by analyzing the circulating tumor DNA, which is released from lung cancer cells into the blood. This blood-based type of genetic testing, called a liquid biopsy, is currently the focus of enthusiastic research and developments worldwide to reduce the burden on the patient.
In genetic testing for lung cancer, a number of therapeutic agents tailored to changes in genes have been developed and have come into practical application early on. The EGFR gene test is one of the typical genetic tests related to lung cancer, mainly because EGFR mutations are among the most common mutations in lung cancer patients. EGFR gene mutations are found in 30% of lung cancer patients worldwide and in 50% of lung cancer cases in Japanese people, making it enough of a reason to consider genetic testing extremely important, said Ricoh.
Whenever patients are considering pharmacotherapy for lung cancer, they are tested for EGFR-activating mutants in order to decide upon a therapeutic agent, as well as for EGFR-resistant mutants in order to investigate what kinds of drug resistance might develop after administration of the therapeutic agent, claimed Ricoh. DNA amplification methods such as Polymerase Chain Reaction (PCR) and next-generation sequencing (NGS) are used in these kinds of genetic testing.
In order to perform highly sensitive genetic testing using the NGS method, DNA Chip Research had already developed the EGFR Liquid, a minimally invasive testing method that detects EGFR genetic mutations in DNA samples extracted from blood, and helps determine the suitability of EGFR inhibitors for patients with non-small cell lung cancer –the most common form of lung cancer. Based on research results from the Nara Institute of Science and Technology and the Osaka International Cancer Institute, this test can detect the EGFR-activating mutants located on small amounts of circulating tumor DNA, together with the even less common resistant mutants.
Schematic diagram of cell-free DNA in blood of lung cancer patient. (Image courtesy of Ricoh)
Ricoh indicated that 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. Through this new collaboration, Ricoh along with DNA Chip Research found a way to develop a reference material that makes possible confirming the accuracy of a highly sensitive genetic test that detects a small amount of cancer cell-derived DNA molecules contained in the blood of lung cancer patients, which contributes to the improvement of the test accuracy itself.
Best known as a multinational imaging and electronics company, Ricoh has gone to great efforts to develop its inkjet-based bioprinting technology and considers the biomedical market as a growth engine. Over the last 12 years, Ricoh has become a presence in the healthcare market with a range of software and accompanying services meant to assist “an aging society,” along with creating products that could make healthcare more affordable. This particular new product is expected to contribute to efforts in genetic testing of lung cancer to improve patient healthcare in the future.