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BioGx Lands CE Mark for Influenza, RSV Assay

NEW YORK (GenomeWeb) – BioGx announced it has received CE-IVD marking for a real-time PCR-based test to detect Influenza A, Influenza B, and respiratory syncytial virus.

The assay uses samples from nasopharyngeal swabs and runs on the Becton Dickinson BD Max system. Offered as a single tube that snaps into the BD Max RNA/DNA extraction cartridge, the test increases lab efficiency, the firm said in a statement.

While BioGx is based in Birmingham, Alabama, the test is not currently available for sale in the US. Additional snap-in tests in the company's Sample-Ready product line will also be available soon, BioGx CEO Shazi Iqbal said in a statement.

This is the latest influenza and RSV assay to get a CE Mark since Luminex's Aries Flu A/B & RSV assay did in July.