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Sysmex Gets Japanese Approval for Coronavirus Antigen Test

NEW YORK — Sysmex said on Wednesday that it has received Japanese marketing approval for its HISCL SARS-CoV-2 Ag Reagent test kit.

The chemiluminescence enzyme immunoassay is designed to detect SARS-CoV-2 antigens in nasopharyngeal and nasal swab samples. It runs on the company's HISCL-5000 and HISCL-800 automated analyzers, providing results within 17 minutes.

According to Sysmex, the kit has also received insurance coverage in Japan and will launch next week.

In March, Kobe, Japan-based Sysmex received Japanese marketing approval to distribute BGI Genomics' 2019-nCoV Fluorescence Detection Real-Time RT-PCR Kit. A few months later, it secured approval for the use of the kit with saliva samples.