October 2, 2020
Denka Company Limited

Expansion of Intended Use and Specimen Types for Denka's COVID 19 Ag Rapid Test kit~To diminish healthcare and patient burden in SARS-CoV-2 and Influenza antigen testing~On October 2nd, Denka Company Limited (headquarters: Chuo-ku, Tokyo; president: Manabu Yamamoto; hereinafter,“Denka”) has received approval from the Ministry of Health, Labour and Welfare, to partially change the market
authorization of QuickNaviTM-COVID19 Ag, to add a new specimen type.
Under the new authorization, a nasal swab specimen (a specimen collected by inserting a swab from nasal cavity by
about 2 centimeters), in addition to the conventional nasopharyngeal swab specimen (a specimen collected from deep inthe nasal cavity), can be used with QuickNavi™-COVID19 Ag. Furthermore, patients are now allowed to collectspecimen themselves under the guidance of a healthcare professional. This reduces the risk of transmission to healthcare
professionals and the burden on patients.
In addition, to be prepared to the coming Flu season, specimens of QuickNavi™-COVID19 Ag taken from a single
swab can also be used with QuickNavi™-Flu2 influenza1 rapid antigen test or QuickNavi™-RSV2 RS2 rapid antigen test.
To expand rapid antigen testing, Denka will put efforts on tests that are easy to use. Those include higher sensitivity andshorter reading time of QuickNavi™- COVID19 Ag in addition to the test that can detect both influenza andSARS-CoV-2 viruses at the same time.
Recommendations (*3) issued by the Japanese Association for Infectious Diseases focus on the need for early
diagnosis and early treatment as well as influenza vaccination concerning SARS-CoV-2 and influenza will
simultaneously spread. As the sole domestic manufacturer to supply influenza vaccines as well as rapid antigen detection
test for various viruses (QuickNavi™ series), Denka is working to prevent the spread of infection through the prevention
to diagnostics.
Denka considers the fight against infectious diseases to be its social responsibility and, with the cooperation and supportof relevant authorities, public agencies and research institutions in Japan and overseas, is conducting research anddevelopment from various perspectives to meet the needs of healthcare professionals and contribute people’s quality oflife by help improve prevention and diagnostic systems.

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1.Quick Procedure Guide and Examples of the Results *Japanese

2．Impact on consolidated financial results for FY2020
Denka will promptly make an announcement if this development is expected to have a considerable impact on Denka’s
consolidated financial results for FY2020.
(*1）Influenza virus
Most common symptoms include a fever of over 38°C, headache, arthralgia and myalgia, and fatigue, and thesesymptoms usually develop rather rapidly. As in the case of the common cold, sore throat, runny nose and coughing
occur as well. Children, rarely, may develop acute encephalopathy, and the elderly and those with weak immunity may
develop secondary pneumonia or other severe symptoms.
（Source: MHLW website“Q&A on Influenza Q&A FY2019）https://www.mhlw.go.jp/bunya/kenkou/kekkaku-kansenshou01/qa.html(*2) RS virus
Respiratory syncytial virus (RSV) is the most frequent cases for respiratory infections in infants and children. It typicallyoccurs in the winter but recent outbreaks in Japan have tended to start during summer and autumn. A majority ofchildren experience their first RSV infection by one year of age, with almost all experiencing their first RSV infection by
two years of age. RSV infections in infants and children need to be monitored carefully as lower respiratory tract
infections (bronchitis, pneumonia, etc.) can cause serious respiratory complications.
（Source: Manual of Pediatric Infectious Diseases edited by Japanese Society for Pediatric Infectious Diseases）(*3) Recommendations of Japanese Association for Infectious Diseases “Preparing for Influenza and COVID-19 forcoming winter” (Japanese only)
http://www.kansensho.or.jp/uploads/files/guidelines/2008_teigen_influenza_covid19.pdf

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References:・Approval 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 ~https://www.denka.co.jp/eng/storage/news/pdf/291/20200811_denka_quicknavi_covid19ag_en.pdf
・Denka Files Application for Japanese in Vitro Diagnostics Approval of a Simple andRapid Testing Kit Infection for the COVID-19 Novel Coronavirus, July 20, 2020
https://www.denka.co.jp/eng/storage/news/pdf/290/20200720_denka_covid19_testingkit_en.pdf
・Notice Regarding the Status of Development of Simple and Rapid Testing Kits for the COVID-19 Novel Coronavirus
Infection, March 24, 2020
https://www.denka.co.jp/eng/storage/news/pdf/275/20200324_denka_seiken_covid19_en.pdf
・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-ku, Tokyo. The company specializes in developing businessactivities on a global scale across a wide range of fields, from 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 technological capabilities. Upholding its corporate
slogan, “Possibility of chemistry,” the company and its president, Manabu Yamamoto, are committed to contributing to thesound development of society while sincerely tackling the challenges that society is now confronting.

[For Inquiries about This Press Release from Media]
Corporate Communications Dept.

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

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