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Bioneer Gets CE-IVD Marks for Combination Coronavirus, Flu Assays

NEW YORK — South Korean diagnostics firm Bioneer said on Wednesday that it has received CE-IVD marking for two combination tests for SARS-CoV-2 and influenza.

The AccuPower RV1 Real-Time RT-PCR Kit and the AccuPower RV1 Multiplex Kit are both designed to detect the E, RdRp, and N genes of SARS-CoV-2, as well as influenza A and B, in a single nasopharyngeal or oropharyngeal sample.

The AccuPower RV1 Real-Time RT-PCR Kit is customized to run on Bioneer's automated ExiStation instrument, while the AccuPower RV1 Multiplex Kit is compatible with other PCR systems including Bio-Rad Laboratories' CFX 96 and Thermo Fisher Scientific's Applied Biosystems 7500 Fast and QuantStudio 5 instruments.

Earlier this year, Bioneer received CE marks for two SARS-CoV-2-only diagnostic kits.