On January 30, 2023 Micronoma, the first biotech company offering early cancer detection with a microbiome-driven liquid biopsy platform, reported that its OncobiotaLUNG assay received the Breakthrough Device Designation from the Food and Drug Administration (FDA) (Press release, Micronoma, JAN 30, 2023, View Source [SID1234626643]).

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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.