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Seegene Gets Australian Approval, CE-IVD Mark for Multiplex Respiratory Virus Test

NEW YORK — Seegene said on Wednesday that it has received Australian approval and CE-IVD marking for its Allplex RV Master Assay for respiratory viruses.

The multiplex real-time PCR test is designed to detect molecular targets for 19 respiratory viruses including SARS-CoV-2, influenza, metapneumovirus, respiratory syncytial virus, adenovirus, and human rhinovirus.

Earlier this year, Seegene received approval under Health Canada's Interim Order for its Allplex SARS-CoV-2/FluA/FluB/RSV Assay. The South Korean company also recently obtained the CE-IVD mark for the Allplex SARS-CoV-2 fast MDx Assay.