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.

The liquid biopsy is able to categorize lung nodules into high-risk or low risk of malignancy “even in the earliest stages of the disease,” Micronoma said.

The Breakthrough Devices program aims to provide timely access to certain medical devices by speeding up their development and review.