Micronoma, the first biotech company offering early cancer detection with a microbiome-driven liquid biopsy platform, announced today that its OncobiotaLUNG assay received the Breakthrough Device Designation from the Food and Drug Administration (FDA).
As a result, Micronoma can expect continued guidance and prioritized reviews from the agency of its upcoming clinical trial and concomitant pre-market approval processes.
The FDA based its Breakthrough Device decision on the ability of Micronoma’s technology to categorize lung nodules into high-risk or low risk of malignancy through a simple blood draw, even in the earliest stages of the disease, compared to the current standard of care.
Read more at Microbiome Post