August 11, 2020
Denka Company LimitedApproval for Manufacturing and Marketing of COVID-19 Rapid Antigen Test in Japan~ QuickNavi™- COVID19 Ag to be distributed to Japanese Medical Institutions starting on August 13 ~< Rapid Antigen Test for COVID-19, QuickNavi™- COVID19 Ag >On August 11th, Denka Company Limited (headquarters: Chuo-ku, Tokyo; president: Manabu Yamamoto;hereinafter, “Denka”) received approval for the manufacturing and marketing of rapid antigen test for
COVID-19 in Japan. As the in vitro diagnostic test, QuickNavi™- COVID19 Ag is to be available for sales for
medical institutions from August 13th with the capacity to produce up to 100,000 tests per day at Denka’s Gosen
Site (Gosen-shi, Niigata). Denka’s marketing alliance partner, Otsuka Pharmaceutical Co., Ltd. (headquarters:Chiyoda-ku, Tokyo; President and Representative Director: Makoto Inoue) also launch QuickNavi™COVID19 Ag on September 1st. The impact of this development on the consolidated financial statements forthe coming fiscal year ending March 2021 is under evaluation. In case this event would give a substantial
impact, Denka would announce accordingly.
QuickNavi™- COVID19 Ag detects the antigens from SARS-CoV-2 in a nasopharyngeal swab sample
within 15 minutes without the need for special testing equipment allowing rapid, simple and near patient testingat healthcare institutions. In addition, to prepare for seasonal influenza season in Japan, Denka is now
developing the test to detect both SARS-CoV-2 and influenza antigens from the single swab sample.
Furthermore, Denka is proactively working to shorten the time to results and to add other types of specimen tobe used.
Considering measures against the COVID-19 novel coronavirus to be the company’s social responsibility,
Denka began developing this product this February, leveraging the technologies and know-how that thecompany has built over the years through the development and manufacturing of diagnostic reagents for
infectious diseases. In response to the rapid global spread of COVID-19 and the increasing demand for thequick expansion of testing systems in Japan, Denka has collaborated with the National Institute of Infectious
Diseases (NIID) through the involvement of the Japan Agency for Medical Research and Development(AMED) project to develop the test. Thanks to their support, Denka accelerated the process by receiving
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antibodies and antigens from NIID.
NIID While it normally takes at least eighteen months to two years from productdesign to receive approval for manufacturing,manufacturing, Denka only took six months to receive the approval with support
from the relevant authorities, public agencies, and research institutions in Japan and overseas
overseas.
Denka believes that this product will be a useful tool in COVID
COVID-19
19 testing system and will eventuallycontribute to improve people's quality of life.
life< QuickNavi™
QuickNavi™- COVID19 Ag Assay Procedure and Interpretation of the Result
esult *Japanese ><ProductProduct Outline
Outline>General NameNSARS Coronavirus Antigen Kit

Product Name

QuickNavi™
QuickNavi™- COVID19 Ag

Approval No.

30200EZX00047000

Specimen

Nasopharyngeal
asopharyngeal swab

Reading TimeT

15 minutes after addition of specimen

Storage

Room temperature (2( to 30℃)

Shelf life

12 months from the date of manufacturing

Units/Packack

10 T
Tests/packTargeted MarketM

Japan Only

Unit Pricerice

60,000 yen for 10 test
tests

Manufacturer/ istributor
Manufacturer/Distributor

Denka Company Limited

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＜Productroduct Photo＞

Positive

Negative

References:
・DenkaDenka Files Application for Japanese in Vitro Diagnostics Approval of a Simple andRapid Testing Kit Infection for the COVID
COVID-19
19 Novel Coronavirus
https://www.denka.co.jp/eng/storage/news/pdf/290/20200720_denka_covid19_testingkit_en.pdf
・Notice
Notice Regarding the Status of Development of Simple and Rapid Testing Kits for theCOVID
COVID-19
19 Novel Coronavirus Infection, March 24, 2020
https://www.denka
https://www.denka.co.jp/eng/storage/news/pdf/275/20200324_denka_seiken_covid19_en.pdf.co.jp/eng/storage/news/pdf/275/20200324_denka_seiken_covid19_en.pdf
・Notice
Notice Regarding Start of the Development of Simple and Rapid Testing Kits for COVID-19,
Novel Coronavirus Infection, February 13, 2020
https://www.denka.co.jp/eng/storage/news/pdf/267/20200213_denka_seiken_covid19_en.pdf

About Denka:
Denka is a chemical manufacturer headquartered in Chuo
Chuo-ku,ku, Tokyo. The company specializes in developing
business activities on a global scale across a wide range of fields, from inorganic and organic chemicals, toelectronic materials and pharmaceuticals. Founded in 1915, Denka has steadily continued to develop andmanufacture products that contribute to thethe development of society by fully utilizing its unique concepts andtechnological capabilities. Upholding its corporate slogan, “Possibility of chemistry,” the company and itspresident, Manabu Yamamoto, are committed to contributing to the sound development
development of society whilesincerely tackling the challenges that society is now confronting.
[For Inquiries about This Press Release from Media]
Corporate Communications Dept.

Tel : +81+81-3-5290-5511
5511[For Inquiries from Medical Personnel]
Life Innovation Dept. Vaccines and Diagnostics Business Headquarters Dept. Tel : +81+81-3-6214-3235

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