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With regard to release plan announcement of “COVID-19 quantitative antibody testing system”

Order-made Medical Research Inc. (Representative director: Yasufumi Murakami) had a press conference in Tokyo on August 13, 2020 (Thursday), with regard to the release plan of a COVID-19 quantitative antibody testing system. We report the contents of the press conference as follows.

Using our own standard antibody makes it possible to analyze whether there is a novel coronavirus infection history with a high degree of accuracy

As of January 2020, we anticipated a pandemic of the novel coronavirus disease (COVID-19) and set out to develop a quantitative antibody testing system. Yasufumi Murakami, our representative director, has developed an influenza diagnostic antibody that accounts for 60% of the world market and 80% of the domestic market. Utilizing this technology, we completed the presently announced quantitative antibody testing system for COVID-19 (hereinafter referred to as “Antibody Testing System”).

The characteristic of the Antibody Testing System is use of an antibody independently developed using our strength, which would be standard of positive/negative diagnosis (hereinafter referred to as “Standard Antibody”). Correcting measured values of sample (plasma) obtained by blood collection by using measured values of the Standard Antibody makes it possible to quantitate as antibody level.

The “antigen ELISA method” used in the Antibody Testing System is known as an ancient immunological measurement method and using 96-well plate, etc. makes it possible to measure many samples at one time. Dr. Takehiko Fujino (Professor Emeritus, Kyushu University), who ascended to Murakami, highly valued the System stating that “the use of antigenic ELISA methods that we have traditionally used has great significance in allowing for simple and accurate testing. It is a breakthrough invention that provides a large amount of information in a simple and accurate manner.”

Further, the Antibody Testing System uses 2 kinds of antigen derived from the novel coronavirus, by which we realized a testing system which allows a sample, that is difficult to make a diagnosis based on 1 kind of antigen, to be diagnosed positive/negative with a high degree of accuracy.

Approximately 1.9% of samples provided by volunteers living in the metropolitan areas were positive.

Between May and early August 2020, we tested 362 samples from volunteers (teenagers to 80s) living in the metropolitan areas, such as Tokyo, recruited in cooperation with DD Supply Co., Ltd. for antibody testing with optimized diagnosis standard in 200 different clinical samples. 7 samples were tested positive, 355 samples were tested negative, and the positive rate was 1.9%.

Summary of antibody testing results of volunteers
Positive testing samples 7 samples
Negative testing samples 355 samples
Number of samples tested so far 362 samples
We determined the presence of antibody to SARS-CoV-2 on 362 samples provided by healthy volunteers (teenagers to 80s) living in the metropolitan areas. Approximately 1.9% had antibody to the novel coronavirus.

It is expected to develop as a tool to verify effects of vaccine

At present, the antibody testing is used to determine the presence of the novel coronavirus infection history. Dr. Ko Okumura, a professor of immunology of Medical Department at Juntendo University who participated in video messaging, placed a hope for future new usage stating that “since effects of vaccine can be evaluated by measuring antibody, the antibody testing is useful for development of vaccine.”

Please note that entrusted analysis of the Antibody Testing is already under operationalization. In cooperation with euglena Co., Ltd. and Leave a Nest Co., Ltd., our joint development partners, we proceed with establishment of a prompt and simple testing system for commencement at as early timing of 2020 as possible.