Micronoma Gets Breakthrough Device Nod for Early Lung Cancer Test

The FDA has granted Breakthrough Device status to Micronoma’s OncobiotaLUNG microbiome-driven blood assay for early lung cancer detection.

Lung cancer is currently diagnosed though computed tomography scanning in which, when an indeterminate lung nodule is found, the patient undergoes additional imaging. If this is inconclusive, the patient undergoes a potentially unnecessary surgical biopsy as 95 percent of imaged lung nodules turn out to be benign.