News on diagnostics for respiratory pathogens, including influenza, coronavirus, and more.
While point-of-care molecular testing of patients with respiratory illness wasn't associated with lower antibiotic use, patients tested had shorter drug courses.
The firm said that its test is the first on the market to detect RSV infection at the point of care in 13 minutes or less.
This is the first assay approved on the firm's next-generation platform-based immunoassay testing system, with assays for influenza and Strep A to follow.
The IGRA testing market is ballooning as industrialized nations try to curb the spread of tuberculosis, but the assays still fall short in certain settings and patient populations.
Commenters told the FDA that antigen-based rapid influenza diagnostic tests have performed poorly, and the reclassification will "mitigate" health risks.
