Otsuka Pharmaceutical Co., Ltd.

October 5, 2020

Quick NaviTM-COVID 19 Ag Rapid Diagnostic Test in Japan Now Enables Test Sample Collection from Front of Nasal Cavity

Testing for Influenza and for RS Virus Can Also Be Done Using a Single Test Sample from Front of Nasal Cavity, in Conjunction with QuickNavi Test Kits

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Denka Company, Limited announce that on October 2, approval in Japan was granted for use of test swabs for the Quick Navi ™ -COVID19 Ag test that enable easy test sample collection from the front of the patient's nasal cavity, approximately two centimeters inward from the nostril. Alterantively, the existing method of using a nasopharyngeal swab to collect a test sample from the back of the naval cavity can continue to be used.

Moreover, a single, front-of-naval-cavity test sample from the patient can be used for all of the following three Quick Navi test kits: the influenza virus antigen rapid diagnostic kit Quick Navi ™ -Flu2, the RS virus antigen rapid kit Quick Navi ™ -RSV2 and the Quick Navi ™ -COVID19 Ag. Use of a single sample to test for three different viruses aids the physician in rapid and accurate diagnosis. The potential reemergence of simultaneous COVID-19 and influenza epidemics during the autumn and winter months ahead illustrates the heightened importance of early diagnosis and treatment.

For the Quick Navi series of diagnostic tests for the three viruses noted above, if test sampling is done at the front of the nasal cavity, patients can collect their own samples under the direction of a medical doctor. This will reduce the burden on patients and may contribute to a reduced risk of infection for healthcare professionals.

QuickNavi ™ -COVID-19 Ag, the newest addition to the QuickNavi ™ series, is a new, antigen-detection diagnostic for COVID-19 that received manufacturing and marketing approval in Japan on August 11. QuickNavi™- COVID19 Ag detects antigens from SARS-CoV-2 in a swab sample within 15 minutes without the need for special testing equipment.