Feature Life Science

Strengths and Growth Strategy for the Diagnosing Infectious Diseases

Developing in vitro diagnostic reagents for SARS-CoV-2
utilizing expertise cultivated through research reagents

Yutaka Ouchi

Yutaka Ouchi
Director & Managing Executive Officer
Head of Life Science Solutions

Amid the rapid spread of COVID-19 in 2020, we launched SARS-CoV-2 genetic test reagents to be used when conducting research on the virus in April. It has been used in research ever since. In addition, we released in vitro diagnostic products in July and have supplied them to medical institutions and testing centers.

We have manufactured and sold research reagents for genetic testing since the 1980s, including reagents to test for norovirus, a common cause of gastroenteritis.

Due to the technical similarities with testing for SARS-CoV-2, we started development from the desire to contribute to society by utilizing these commonalities. We have continuously invested resources in research and development in the genetic testing field and refined our technologies for more than 20 years, constituting our technological foundation. Because of this, we were able to quickly move forward with this development.

Furthermore, launched an in vitro diagnostic SARS-CoV-2 detection kit using immunochromatography in June 2021.

Promoting joint research for the establishment of more efficient testing methods

In fiscal 2021, we also undertook research aimed at improving the reliability and safety of tests, and shortening the time it takes from collecting specimens to assessing the results.

Reducing the duration of the test will allow us to test a larger volume of specimens, leading to more efficient testing. For this, we started a collaborative research project with the Kitasato Institute and Tsubakimoto Chain Co. to establish a next-generation automated testing system. This research started when the Kitasato Institute approached us after recognizing our achievements in the research reagents field. We strongly endorsed the meaningful project and decided to participate in the joint research. The research was adopted and started by the Japan Agency for Medical Research and Development (AMED) as part of the FY2021 Program to Develop Countermeasure Technologies against Viral and Other Infectious Diseases (3rd) (Development and Demonstration Research Support for Establishing New Testing Methods and Systems, etc. to Achieve Early and Mass Infectious Disease Testing).

Experimental landscape_trimmed

The joint research uses a pooling test method. We previously had to collect saliva samples from one person, test it once, and then see if it was positive or negative. However, with the pooling test method, specimens from up to five people can be collected and tested together at once.While we would normally have to perform 100 tests if we collected 100 different specimens, if they are all negative, it only takes 20 tests, or just one-fifth the number. When a group tests positive, we only need to test those five specimens again. This greatly reduces the number of tests and leads to increased efficiency and cost savings.

We are conducting this research not only in the medical field, but also with a view to utilizing it in entry screen at airports, which require rapid and mass testing systems, and the construction of testing infrastructure at venues such as large-scale international sporting events.

Aiming to become the No. 1 provider of solutions for the diagnosis of infectious diseases

In the genetic testing field, we manufacture the reagents for PCR tests in addition to the raw materials for them. For example,
according to our own estimates, we boast the world’s second largest share of the raw materials for biochemical reagents used in the measurement of neutral fat and cholesterol during medical examinations and other settings. In addition, we possess an outstanding level of biotechnology, particularly with highly functional proteins such as enzymes and antibodies. For instance, the antigen testing kit using antibodies for SARS-CoV-2, which was developed in collaboration with the University of Toyama, is an example of the utilization of our unique technology for highly functional proteins. The antibodies it uses were developed through participation in AMED’s FY2020 Research Program on Emerging and Re-emerging Infectious Diseases (2nd) (Research on the Development of Immediate Clinical Testing Methods for SARS-CoV-2).

Although the world had paid insufficient attention to the threat of infectious diseases, a global response is now required to combat the spread of COVID-19. In addition to COVID-19, there are other infectious diseases, including avian influenza, that risk causing pandemics in the future and finding measures against them have become an important social issue.

In the future, we will actively invest in the infectious disease diagnostics area and set broader targets. We aim to become the top provider of solutions for diagnoses of infectious diseases not only domestically but also globally, with an eye on genetic testing and the entire diagnosis business at large. In this way, we want to contribute even more to solving the global issue of the spread of infectious diseases.

Fully automated gene analysis system GENECUBE®

Fully automated gene analysis system
GENECUBE®

(From left) SARS-CoV-2 Detection Kit -N set-SARS-CoV-2 Detection Kit -N2 set-

(From left)
「SARS-CoV-2 Detection Kit -N set-」
「SARS-CoV-2 Detection Kit -N2 set-」

Message from the General Manager

Atsushi Sogabe

Atsushi Sogabe
General Manager,
Biotechnology Operating
Department and Manager,
Bioproducts Sales Department, and Bioproducts Development Department

Creating edgy technologies

Our Group has been in the PCR business for more than 30 years. In 1995, we started selling PCR enzymes under the KOD® brand, and have continuously reviewed and changed models since then.

To improve the performance of PCR reagents, it is important to also remember the substances that assist the function of the main enzymes. Because both are made of proteins, we cannot produce good reagents without excellent technology to make proteins.

We have refined the technology to enhance the function of proteins and to produce them efficiently through many years of research. In addition, we have also enhanced the performance of reagents themselves by combining them with these highly functional proteins, as well as creating reagents with many distinct properties.

Thanks to these achievements, we enjoy a high degree of recognition in the reagent industry. The Group has many opportunities to participate in joint development and other activities as a result of being introduced to cutting-edge technologies by professors in academia.


Atsushi Sogabe

Atsushi Sogabe
General Manager,
Biotechnology Operating
Department and Manager,
Bioproducts Sales Department, and
Bioproducts Development Department
History of Research Reagents

Creating edgy technologies
Our Group has been in the PCR business for more than 30 years. In 1995, we started selling PCR enzymes under the KOD® brand, and have continuously reviewed and changed models since then.
To improve the performance of PCR reagents, it is important to also remember the substances that assist the function of the main enzymes. Because both are made of proteins, we cannot produce good reagents without excellent technology to make proteins.

We have refined the technology to enhance the function of proteins and to produce them efficiently through many years of research. In addition, we have also enhanced the performance of reagents themselves by combining them with these highly functional proteins, as well as creating reagents with many distinct properties.

Thanks to these achievements, we enjoy a high degree of recognition in the reagent industry. The Group has many opportunities to participate in joint development and other activities as a result of being introduced to cutting-edge technologies by professors in academia.


History of Research Reagents

1982 Started business with three restriction enzymes
1989 Launched our first PCR enzyme, rTth DNA polymerase
1995 Launched the PCR enzyme KOD® DNA Polymerase, our current core brand, and have continued improvements
2014 Launched the Norovirus Detection Kit, a norovirus testing reagent, and have continued improvements
2020 Gained approval for our SARS-CoV-2 genetic testing reagent to be covered by public medical insurance as a method in conformance with the Manual for Pathogen Detection 2019-nCoV (issued by the National Institute of Infectious Diseases)