January 29, 2021
Denka Company Limited

Application for PMDA Approval of a Test Kit for Simultaneously Detecting Both the COVID
COVID-19
Coronavirus and Influenza Viruses in Japan
Denka Company Limited (headquarters: Chuo-ku,Chuo ku, Tokyo; president: Manabu Yamamoto; hereinafter, “Denka”) has
developed a rapid antigen test kit that enables the simultaneous detection of both SARS-CoV-2
SARS
2 (the COVID
COVID-19
coronavirus) and influenza viruses using one device (hereinafter the "Combo Kit"), and today submitted an application forapproval as an inin-vitrovitro diagnostic in Japan to the Pharmaceuticals and Medical Devices Agency (PMDA) .
The Combo Kit uses the immunochromatography method to detect SARSSARS-CoV-2 antigens and influenza (Type(Type-A andType-B)B) antigens using one device, and quickly determines results, positive or negative. It is difficult to diagnose
SARS-CoV-2
2 and influenza infections from symptoms. The use of the Combo Kit,
Kit, which is able to detect both at thesame time, is expected to enable patients to receive the proper treatment and reduce the burdens borne by health careworkers.
Denka has been involved in the test reagent business for years, where it has provided QuickNavi™
QuickNavi™-Flu2,Flu2, an influenza
rapid antigen test kit, and QuickNavi™
QuickNavi™-Adeno2,Adeno2, an adenovirus rapid antigen test kit. Additionally, last year on August 13,
Denka released QuickNavi™
QuickNavi™-COVID19
COVID19 Ag, the SARSSARS-CoV-2
2 rapid antigen test. Working together with its sales ppartner,
artner,
Otsuka Pharmaceutical Co., Ltd., Denka supplies this test kit to medical institutions nationwide.
QuickNavi™
QuickNavi™-COVID19
COVID19 Ag is a reagent that detects the existence of SARSSARS-CoV
CoV-22 antigens in a nasopharyngeal swabspecimen or a nasal swab specimen without
without requiring a specific test device, in about 15 minutes. Because it enables any
hospital to quickly and simply test for the disease, it is increasingly used. After its release, to contribute to the expansion ofantigen testing, Denka increased its production capacity equivalent from 100,000 tests a day in October to up to 130,000
tests a day in November.

Denka recognizes it bears the social responsibility of carrying out measures to prevent infection. Through a sufficient
supply capacity, Denka wiwillll help improve COVID-19
COVID 19 antigen testing in clinics and hospitals.
About Denka
Denka is a chemical manufacturer headquartered in Chuo
Chuo-ku,ku, Tokyo. The company specializes in developing businessactivities on a global scale across a wide range of fields, fr
fromom inorganic and organic chemicals, to electronic materials andpharmaceuticals. Founded in 1915, Denka has steadily continued to develop and manufacture products that contribute to
the development of society by fully utilizing its unique concepts and techtechnologicalnological capabilities. Upholding its corporate
slogan,ogan, “Possibility of chemistrychemistry”” the company and its president, Manabu Yamamoto, are committed to contributing to
the sound development of the society while sincerely tackling the challenges that the societysociety is now confronting.
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