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Corporate Japan rushes to devise quick coronavirus tests

New kits may arrive in summer but some will face government scrutiny

Japanese companies have joined the global scramble to come up with a faster coronavirus test that does not compromise on accuracy.   © 2020 IVDC China CDC/ Kyodo

TOKYO -- With COVID-19 spreading from China to other countries, pharmaceutical, chemical and other companies are rushing to develop quick test kits that promise to facilitate quarantine procedures.

COVID-19 is the new name for the novel coronavirus discovered in China in December. It has so far infected more than 70,000 people and killed 1,770. Most of the cases and deaths have been recorded in mainland China, though the virus has been reported in at least 26 countries.

Swiss multinational health care company Roche and Japanese mid-size chemical maker Denka have joined the rush to build a better test kit, along with Chinese parties.

At quarantine centers, sputum and throat mucus samples are taken from patients with high fevers and pneumonia symptoms. The number of genes from these samples is then increased so that the amplified samples can be examined for the presence of COVID-19 genes.

In Japan, SRL, a clinical examination company belonging to Miraka Holdings, accepted samples from 300 to 400 people last week at the request of the Ministry of Health, Labor and Welfare. BML, another clinical examiner, began examining samples at the ministry's request on Monday.

It takes six hours for test results to come back. A kit that promises much faster results could be applied on a wider scale. Currently, COVID-19 carriers who have not begun showing symptoms are falling through the cracks.

There have been breakthroughs.

In late January, China's national institute of infectious diseases and a company in Jiangsu Province announced the joint development of a technology that can promptly determine whether the virus is present. And Roche has developed a kit jointly with Tib Molbiol, a German maker of diagnostic products.

The Roche kit uses a polymerase chain reaction to rapidly make millions or billions of a specific gene. The kit is capable of showing analysis results in three and a half hours, according to Roche.

Although the kit has yet to be authorized as a diagnostic product for clinical use, Roche has supplied it to the Wuhan municipal government in Hubei Province so local authorities can judge whether they want to use it.

Veredus Laboratories, a Singapore-based medical device company owned by Japan's Sekisui Chemical, is also working on a test kit.

In Japan, the government is developing simple kits in cooperation with businesses. Denka Seiken, a diagnostic reagent production unit of Denka, is developing a kit that uses antibodies to detect the presence of the coronavirus. When sputum and throat mucous membrane samples are put on a testing device, the virus sticks to an antibody and causes a change in color, according to Denka Seiken.

Unlike the gene-amplification method, this kind of kit does not need any special testing equipment or operating expertise -- and results are returned in three to five minutes. Denka Seikan is presumed to be developing an antibody that sticks only to the coronavirus.

Fujirebio, a Miraka group member that makes and sells reagents and diagnostic equipment, is collecting information on testing techniques and quality thresholds desired by the government. Fujirebio sells diagnostic products for influenza and other infectious diseases. It has also conducted studies on testing methods for SARS, the coronavirus that killed almost 800 people nearly two decades ago, as well as for the mosquito-carried Zika virus.

Basic COVID-19 test kits under development in various countries are expected to become usable in three to four months, if the desired antibody is produced.

Japan's National Institute of Infectious Diseases has succeeded in isolating and cultivating the coronavirus. The National Institutes of Biochemical Innovation, Health and Nutrition will distribute the information on behalf of the NIID to companies and research institutes by the end of this month. This means test kits could become available this summer at the earliest.

Eiken Chemical, which developed a high precision test kit after SARS began to spread in 2003, has an original method of amplifying viruses. The method, called LAMP, can confirm a virus in an hour or so at about the same accuracy as the polymerase chain reaction, or PCR, method and is considered applicable to the coronavirus.

Although they spit out much faster results, simple test kits are less accurate than those that use the PCR method. They face another hurdle: If they are developed, they cannot be used clinically without government approval, which can take years.

These authorization procedures may be addressed amid the outbreak.

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