Miraca unit seeks approval for Japan's first coronavirus antigen tests (updated)
27/04/2020 16:38
(Adds details, background)
By Kiyoshi Takenaka
TOKYO, April 27 (Reuters) - Fujirebio, a subsidiary of
Japanese diagnostics and laboratory testing service provider
Miraca Holdings 4544.T , applied on Monday for government
approval for Japan's first antigen coronavirus testing kits, a
health ministry official said.
Japan's sole official test for coronavirus diagnosis is a
polymerase chain reaction, or PCR, test. Antigen tests can be
conducted more quickly, in about half an hour, potentially
making virus tests more accessible to the public if approved.
The application will be fast-tracked, the official said.
"We usually aim to complete our review for approval within a
year. But we will tackle this one as swiftly as possible,"
Takuma Kato, deputy director of the ministry's tuberculosis and
infectious diseases control division, told Reuters.
Approval will likely be issued by the end of May, Kyodo news
agency said, without citing sources.
There has been widespread criticism that phone lines for
public health centres, tasked with conducting screening for PCR
test candidates, are always busy and test results are slow to
come by.
Critics say the low rate of testing in Japan has made it
difficult to trace the new coronavirus, which can cause the
COVID-19 respiratory disease, as it spreads and that this has
led to a series of in-hospital infections, crippling some
facilities.
Japan conducted about 52,000 PCR tests in March, or just 16%
of the number carried out in South Korea, according to data from
Oxford University.
A Miraca Holdings spokeswoman confirmed Fujirebio had filed
for government approval but declined to give details, saying an
official announcement would be made soon.
An antigen test targets the virus's protein to establish
whether a person has the disease. An antibody test is used to
detect those who have been infected with the virus and therefore
had immunity.
Japan had reported 13,613 coronavirus infections as of late
Monday evening, with 394 deaths, public broadcaster NHK said.
(Reporting by Kiyoshi Takenaka; Editing by Hugh Lawson and
Timothy Heritage)
((kiyoshi.takenaka@thomsonreuters.com; +81 3 4563 2788;))