Shionogi Announces Novel Coronavirus Antigen test agent “LumiraDx SARS-CoV-2 Ag Test Strip” and diagnostic instrument launched in Japan

OSAKA, Japan, May, 24, 2021 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President and CEO: Isao Teshirogi, Ph.D. ; hereafter “Shionogi”) is pleased to announce that Shionogi has launched novel coronavirus (SARS-CoV-2) antigen test “LumiraDx SARS-CoV-2 Ag Test” and “LumiraDx Instrument” in Japan.


The LumiraDx SARS-CoV-2 Ag Test combines high-sensitivity results comparable to those from the PCR with speed and efficiency (results in less than 12 minutes) using samples from a nasopharyngeal swab or nasal swab.1


The test and platform have already been marketed in Japan, the United States, Europe, and other countries by LumiraDx group. Beginning today in Japan, they will now be marketed by Shionogi and LumiraDx Japan Co., Ltd. (Head Office: Tokyo, Japan; President and CEO: Keisuke Kato).2


Shionogi is committed to “Protecting people worldwide from the threat of infectious diseases” as our key focus. We are not limiting ourselves to the research and development of therapeutic medications, but are also focused on the total care of infectious disease through pre-symptomatic, awareness building, prevention and diagnosis and suppression of exacerbation. To contribute the restoration of social security and safety through the early end of the pandemic, Shionogi will provide this test agent and instrument to medical institute.


About LumiraDx Japan Co., Ltd.

LumiraDx Japan Co., Ltd. is the Japanese company of LumiraDx group, which is headquartered in the United Kingdom. Founded in 2014, LumiraDx develops, manufactures and commercializes an innovative point of care diagnostic platform designed to deliver lab comparable diagnostic results at the point of care in minutes. The company currently has a pipeline of 30 assays across common conditions including infectious disease, cardiovascular disease, diabetes, and coagulation disorders which will all help healthcare decisions affordable and accessible.

Please see the company website for details.LumiraDx Japan Co., Ltd. website


About LumiraDx SARS-CoV-2 Ag Test Strip

“LumiraDx SARS-CoV-2 Ag Test Strip” is a rapid microfluidic immunofluorescence assay that detects SARS-CoV-2 antigen in nasal swab specimens or nasopharyngeal swab specimens collected from individuals suspected of COVID-19 infection, with results in 12 minutes. In comparison with the PCR using samples from a nasopharyngeal swab, this antigen test agent has a positive agreement rate of 97.5% (39/40) and a negative agreement rate of 97.7% (210/215). In comparison with the PCR using samples from a nasal swab, the test has a positive agreement rate of 97.6% (81/83) and a negative agreement rate of 96.6% (168/174), showing high positive/negative agreement rates with the PCR1.



1.         LumiraDx SARS-CoV-2 Ag Test package insert


2.         Press release on April 16, 2021
Shionogi Announces Agreement of Joint Sales with LumiraDx Japan Co., Ltd. for Novel Coronavirus Antigen test agent “LumiraDx SARS-CoV-2 Ag Test Strip” and diagnostic instrument in Japan


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