HONG KONG – Japan’s Ministry of Health, Labour and Welfare (MHLW) has given the green light to Tokyo-based Fujirebio Inc.’s antigen test kit.

Fumihito Takanashi, a spokesperson from the medical device evaluation division of the MHLW, told BioWorld that the approval came into effect May 14.

Fujirebio, a subsidiary of Miraca Holdings Inc., was granted “prioritized, expedited” review given the urgent need for items related to the COVID-19 pandemic.

The company submitted their application on April 27, 2020. A standard review usually takes one year to go through.

However, Takanashi said the MHLW had placed some conditions on the company.

“A smaller number of samples was taken than for the standard approval because of the expedited approval. But the company must submit the results of a four-month clinical performance study,” he said.

No deadline was specified for the data submission, but it is understood that it would be required “as soon as possible.”

The company would also be required to evaluate itself internally, at one- to three-year intervals. That period has not yet been specified for Fujirebio.

But nonetheless, no further red tape holds Fujirebio back, and it can start distributing the kits within Japan as of now.

Japan has set a test target to test 400,000 people per week for the coronavirus. Fujirebio has said it can supply about 200,000 of its test kits per week, with possible plans to scale up its output to meet further demand.

Fujirebio’s test is able to provide results faster by using naso- or oropharyngeal swabs without pre-treatment compared to current testing methods. The sample to result time is estimated to be between 75 to 90 minutes.

It also offers flexible sample numbers per run with no waste of reagents.

In comparison, the currently common polymerase chain reaction (PCR) test requires a few hours and lab work to produce a result.

But the PCR test’s higher sensitivity means that it will still be used to ensure accurate results, even when Japanese patients have tested negative with the antigen test. This was confirmed by Japanese Health Minister Katsunobu Kato to parliament last week.

Testing is a key priority in Japan given a second spike in COVID-19 cases recently.

“Unlike South Korea, testing in Japan was not scaled up to the general public and was limited to those fitting specific criteria," said Kasey Fu, the director of epidemiology at market consultancy group Globaldata.

She believes the new wave of cases was likely due to a combination of uncontrolled imported cases, undetected domestic transmission, and failure to meet testing demands.

Given the fast-tracked approval awarded to Gilead Sciences Inc.’s remdesivir to treat severe COVID-19, and government support for Fujifilm Corp. Holding’s Avigan (favipiravir) as another possible treatment for milder cases, the Japanese government seems to be taking the steps necessary to stamp out the pandemic within its borders.

Japan also has put in place an economic stimulus package worth $1 trillion. Almost a quarter of the budget – ¥2.5 trillion (US$23 billion) – has been set aside to assist medical institutions and pay for the development of drugs to treat coronavirus patients.

It is expected that Fujirebio’s test will be covered by Japan's public insurance system. This means that patients who have been advised by doctors to take the test will not be out-of-pocket.

The Japanese approval isn’t the only recent win for Fujirebio. A day before the MHLW approval, the company reported that its COVID-19 detection kit had also received the CE mark from the EU. In April, the kit was also granted emergency use authorization by the U.S. FDA on April 10.

Last week, the U.S. approved its first homegrown coronavirus antigen kit, made by San Diego-based Quidel Corp.

The need for antigen testing was underscored last month by Deborah Birx, the White House coronavirus response coordinator.

"We have to realize that we have to have a breakthrough innovation in testing," said Birx. "We have to be able to detect antigens, rather than constantly trying to detect the actual live virus, or the viral particles itself," she added.

But others warned against using unvalidated test kits in the scramble to increase testing.

“The problem is that these are tests that need to be validated and calibrated, and many of the tests out there don’t do that. So even though you hear about companies flooding the market with these antibody tests, a lot of them are not validated,” said Anthony Fauci, another member of the White House coronavirus task force, in an interview.

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