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BioGx Gets CE-IVD Mark for Respiratory Infection Assay

NEW YORK — BioGx said on Tuesday that it has received CE-IVD marking for its expanded respiratory infection assay.

The automated test is designed to detect RNA specific to influenza A, influenza B, respiratory syncytial virus A, and respiratory syncytial virus B present in nasal wash, pharyngeal swab, and nasopharyngeal swab collections. It runs on Becton Dickinson's PCR-based BD Max platform and covers a greater range of viral stains and specimen types than a previously released test, according to Birmingham, Alabama-based BioGx.

The test, called OSR for BD Max, will be commercialized in Europe by BioGx's Dutch subsidiary. It is the company's 23rd CE-IVD-marked test to be released for the BD Max system within two years, the company said.