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BioGX BV Gets CE-IVD Mark for Coronavirus, Flu, RSV Combo Test

NEW YORK — BioGX BV said on Tuesday that it has received CE-IVD marking for an RT-PCR-based test for the simultaneous detection of SARS-CoV-2, influenza A and B, and respiratory syncytial virus.

The test detects viral RNA in pharyngeal and nasopharyngeal swab specimens and is designed to run on Becton Dickinson's BD Max system. It comes in BioGX's Sample-Ready ready-to-use format, which includes all RT-PCR reagents in a single tube, the company said. The test is not available in the US.

BioGX BV is the Dutch subsidiary of Birmingham, Alabama-based BioGX.

In April, BioGX received Emergency Use Authorization from the US Food and Drug Administration for a SARS-CoV-2 test that runs on the BD Max system.