January 21, 2021 | News & Notices Sales of Novel Coronavirus PCR Testing Reagent Kits outside Japan Exports Began
Shimadzu Corporation will begin fully rolling out sales of the novel coronavirus (SARS-CoV-2) detection reagent kits outside Japan. On January 19th, Shimadzu obtained provisional authorization from the Singapore Health Sciences Authority (HSA) to sell the kits and will start exporting the kits to Southeast Asian markets through Shimadzu (Asia Pacific) Pte. Ltd., the Asia/Oceania regional headquarter, beginning in early February.
In the United States, sales started in September of last year for use in laboratory developed tests (LDT) based on a U.S. Food and Drug Administration (FDA) emergency use authorization (EUA). In Austria, sales for use as research reagents started in October and preparations are currently underway for exporting the reagents to France, Croatia, and other EU countries.
Shimadzu has been manufacturing the reagent kits for research use in Japan since April of last year and then in September obtained authorization from Japan’s Ministry of Health, Labour and Welfare to manufacture and sell the kits as a drug for in vitro diagnostic use. Shimadzu remains committed to increasing its contribution to preventing the spread of infections in Japan and throughout the world by offering testing reagents and instruments in the future as well. Shimadzu expects to produce up to 3,000 kits (for 300,000 tests) per month for export markets.