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Sysmex Receives Japanese Marketing Approval for Flu Antigen Test

NEW YORK – Sysmex announced on Friday that it has received in vitro diagnostic approval for manufacturing and marketing of its HISCL Influenza Assay Kit in Japan. 

The chemiluminescence enzyme immunoassay detects influenza A/B antigens from nasopharyngeal or nasal swabs and is used on the firm's HISCL-5000/HISCL-800 automated immunoassay analyzers, the company said in a statement. The HISCL-5000 returns results in 17 minutes and processes 200 tests an hour. Sysmex also received insurance coverage for the test, which is expected to launch at the end of February. 

Sysmex emphasized that the influenza antigen test can be used in conjunction with the firm's HISCL SARS-CoV-2 Ag Reagent to measure antigens for influenza and SARS-CoV-2 with a single sample. This will "reduce the burden on both medical professionals and patients and contribute to prompt and appropriate treatment for patients with fever and respiratory systems," the company said. 

Sysmex received Japanese marketing approval for its SARS-CoV-2 test kit in November.