March 19, 2020
Canon Medical Systems Corporation (Headquarters: Otawara, Tochigi Prefecture, Japan; President and CEO: Toshio Takiguchi) has begun research into the practical application of a new rapid genetic testing system for the novel coronavirus (SARS-CoV-2) which is being developed by Canon Medical Systems Corporation1) in cooperation with Nagasaki University. This is part of the company’s contribution to a basic research and development project focusing on rapid diagnostic test kits for coronavirus disease 2019 (COVID-19) which is administered under a research program for the development of diagnostic methods for COVID-19 led by the Japan Agency for Medical Research and Development (AMED).
In cooperation with Professor Jiro Yasuda (Institute of Tropical Medicine, National Research Center for the Control and Prevention of Infectious Diseases, Nagasaki University), Canon Medical Systems Corporation has started development of a testing system that employs a gene amplification technique known as the fluorescent LAMP method.2) Canon Medical Systems Corporation has been working on both basic verification (including sensitivity, specificity, and speed of detection) and clinical verification employing clinical specimens collected from infected individuals. It has been demonstrated that the testing system can provide results within 25 minutes and can detect 15 or more viral genome copies within approximately 10 minutes in positive specimens. In addition, the system has high specificity, with no false positives caused by the presence of SARS-CoV (the virus responsible for SARS).
Urgent measures against COVID-19 are essential because the disease has become a worldwide threat and a huge public health challenge. However, rapid testing techniques that are suitable for use at clinical sites have not yet been introduced in Japan. Compared to conventional real-time PCR, which requires approximately 4 hours to detect a novel coronavirus gene in patient specimens, the newly developed testing system can detect viral genes with almost the same level of sensitivity in a much shorter time. The entire procedure, including extraction of the viral genome prior to testing, can be completed in a short time of 40 minutes or less. Other advantages of this testing system are its light weight, compact design, and ease of operation, which allow the system to be used at a wide range of clinical sites, including remote locations such as isolated islands. The testing system is capable of performing 224 or more tests in an 8-hour day.
In the verification process of the testing system, the same preprocessing method as used in conventional real-time PCR (i.e., viral genome extraction) was employed. However, during the development phase, even with the use of inactivated samples treated by an extremely simple preprocessing method such as exposure of a throat or nasal swab specimen to a temperature of 95°C for 10 minutes, it was confirmed that the testing system is capable of detecting viral genes in a shorter detection time and with a sensitivity comparable to that of conventional real-time PCR using samples that have undergone viral gene extraction. Even after the new testing system has entered the practical application phase, Canon Medical Systems Corporation will continue refining the system to allow testing to be performed more easily and quickly and to further improve safety and operability.
To ensure that the testing system can be applied as effectively and quickly as possible after its development, Canon Medical Systems Corporation, Mr. Tomoya Saito (Director of the Department of Health Crisis Management, National Institute of Public Health of Japan), and other involved parties have established a joint research project to develop operational procedures that take full advantage of the features of the testing system and to promote the smooth introduction of the testing system to the public. This project is part of a research program focusing on risk evaluation of emerging and re-emerging infectious diseases and the implementation of emergency management functions which is being conducted under Health and Labour Science Research Grants. As a measure to strengthen the testing programs in each region, Canon Medical Systems Corporation plans to take initial steps such as planning, developing, and verifying methods for expanding the number of testing opportunities to obtain test results as rapidly as possible by gradually expanding the range of research in order to address the specific needs of each region.
The research and development of this testing system is being carried out as a part of the following two projects: emergency research for COVID-19 in Asia through cooperation of infectious disease research institutions,3) for which Nagasaki University has received a Grant-in-Aid for Scientific Research (Grant-in-Aid for Special Purposes) from the Ministry of Education, Culture, Sports, Science and Technology of Japan; and research focusing on the development of diagnostic methods for COVID-19,4) which is being conducted under the leadership of AMED and in which Canon Medical Systems Corporation has been selected to participate.
Canon Medical Systems Corporation is committed to promoting the safety and security of global society by quickly developing and introducing this rapid genetic testing system.
2) A nucleic acid amplification method known as LAMP (loop-mediated isothermal amplification) developed by Eiken Chemical Co., Ltd.
3) At the website of the Ministry of Education, Culture, Sports, Science and Technology of Japan:
4) At the AMED website: