FDAnews
www.fdanews.com/articles/193173-biogx-earns-ce-mark-for-flu-assay

BioGX Earns CE Mark for Flu Assay

October 22, 2019

BioGX received the CE Mark for its new Flu A, Flu B, RSV A/B automated test, which features enhancements over the original product.

The test qualitatively detects RNA specific to influenza A and B, respiratory syncytial virus A and B and pharyngeal and nasopharyngeal swabs taken from individuals at risk of respiratory viral infections.

The new assay improves detection sensitivity and increases the number of specimen types covered. The company says additional diagnostic tests using the same technology will be available soon.

View today's stories