GSK will use the Breath Biopsy to assess whether the right treatment for the right patient can be identified, and to evaluate its drug candidate for COPD.
While point-of-care molecular testing of patients with respiratory illness wasn't associated with lower antibiotic use, patients tested had shorter drug courses.
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.
CLIA waivers are driving the promise of MDx uptake in physicians’ offices, but achieving adoption in larger settings will remain a strategic imperative.
Among people with a wheeze, the test people can identify people with asthma, but among the asymptomatic public, it is better at identifying people who don't have asthma.
