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Japan makers scramble to develop fully automated PCR testing system ahead of 2nd wave

A fully automated PCR testing system supplied to a foreign maker by Precision System Science Co. on an OEM deal is seen in Matsudo, Chiba Prefecture, on May 18, 2020. (Mainichi/Takehiko Onishi)

TOKYO -- Japanese manufacturers are scrambling to develop and produce medical equipment, protective gear and testing apparatus in preparation for a possible second wave of novel coronavirus infections following the complete lifting of the state of emergency in Japan on May 25.

The development of systems to domestically conduct fully automated coronavirus testing that would greatly facilitate polymerase chain reaction (PCR) tests and other testing methods is underway. In May, the government authorized a reagent for coronavirus testing developed by a Japanese manufacturer, and another domestic maker's testing apparatus with a record of success in Europe is also expected to be approved soon.

Currently, it takes about six hours to complete a testing method in which viral genes are extracted from nasal mucosa and other samples collected from the patient and determine their infection status. Because of the use of multiple reagents and other factors, the testing method requires a great deal of manual labor and manpower. If people carrying out the tests make a mistake, they are exposed to virus infection risks.

Meanwhile, a fully automated system can shorten the testing time to one or two hours. It requires hardly any effort to conduct the process, from setting test samples in equipment to detecting the virus, which can also curb infection risks. In order to realize such a system, however, devices that can process multiple specimens simultaneously as well as reagents for detecting the coronavirus are required.

In Japan, Roche of Switzerland and other European and U.S. manufacturers are leading the testing apparatus market, and a reagent for detecting the coronavirus was approved in April. Domestic manufacturers are also rushing to develop testing machines and reagents to have them licensed.

On May 8, Fujifilm Wako Pure Chemical Corp. based in the western Japan city of Osaka released a reagent for use in its fully automatic equipment for coronavirus testing. Meanwhile, Tosoh Corp. based in Tokyo's Minato Ward is rushing to commercialize a reagent for use in its automated apparatus for transcription reverse-transcription concerted reaction testing, which has been introduced at several medical institutions.

Precision System Science Co. (PSS) based in the city of Matsudo, Chiba Prefecture, east of Tokyo, has recently stirred an online buzz for its success abroad. Since around 2015, the company has supplied apparatus to French pharmaceutical maker ELITech under an original equipment manufacturer (OEM) deal, and was commended with a letter of appreciation by the French ambassador to Japan for its contribution to the coronavirus response.

However, as there had previously been lower demand for testing in Japan than in other countries due to the little damage it suffered from SARS, or severe acute respiratory syndrome, "We'd never thought about getting our apparatus licensed in Japan," confided PSS President Hideji Tajima, 71.

In response to the spread of coronavirus infections in Japan, the company began work to get its apparatus authorized by the Ministry of Health, Labor and Welfare in March this year. However, preparations for filing paperwork and other processes were delayed because the firm was not accustomed to administrative procedures. After the company came under the spotlight due to the commendation by the French ambassador, a concerned individual asked the firm in May, "Why has your application (for licensing) been delayed?" The company is expected to be granted a license shortly and will be able to release its testing device and reagent in Japan soon.

However, even if the coronavirus testing ability improves in Japan, manpower for collecting samples from patients and suspected cases has already been in severely short supply. There is no immediate prospect of eliminating various bottleneck factors that are hindering swift coronavirus testing.

(Japanese original by Hironori Takechi, Political News Department)

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