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Sysmex Obtains Japan Marketing Approval to Distribute BGI Genomics Coronavirus Kit

NEW YORK – Sysmex said Friday it has obtained marketing approval in Japan for the distribution of BGI Genomics' 2019-nCoV Fluorescence Detection Real-Time RT-PCR Kit.

Financial and other terms of the agreement were not disclosed.

Sysmex said that as part of its effort to halt the further spread of COVID-19 in Japan, it has inked a distribution agreement with Shenzhen, China-based BGI, whose novel coronavirus nucleic acid detection kits have received orders from more than 50 countries following marketing approval in China and CE marking. BGI announced on Friday that the US Food and Drug Administration has issued Emergency Use Authorization for the test.

The kit detects the RNA of SARS-CoV-2 extracted from upper respiratory tract swabs or lower respiratory tract sputum or bronchoalveolar lavage fluids.

Kobe, Japan-based Sysmex said it has been working to obtain marketing approval for the provision of the kits in clinical settings in Japan and now anticipates delivery to medical institutions there this month for diagnosis of the SARS-CoV-2 infection.

The company noted that the Japanese government has established the Novel Coronavirus Response Headquarters to promote measures against COVID-19 and direct efforts to prevent the spread and severity of infections.