FDA Grants Novel Liquid Biopsy Assay Breakthrough Device Designation to Detect Lung Cancer


OncobiotaLUNG, a novel liquid biopsy that detects lung cancer, now has a breakthrough device designation from the FDA.

The FDA has granted breakthrough device designation to the novel, microbiome-driven, liquid biopsy assay OncobiotaLUNG for the detection of lung carcinomas, according to a press release from developer Micronoma.1

The assay is one of the first blood microbiome­–driven assays to demonstrate confirmed efficacy such as identification of early-stage lung cancer, according to Micronoma. The assay could potentially improve standard-of-care strategies for those with lung nodules who may have lung carcinoma, detecting disease as early as stage I.

Guidance and prioritized review for upcoming clinical research on and pre-market approval processes for OncobiotaLUNG are anticipated. The designation was based on the assay’s ability to categorize nodules as being high-risk or low-risk via a blood test compared with standard-of-care (SOC) assays.

Current SOC dictates that indeterminate lung nodules be monitored via additional imaging such as PET/CT scans and low dose computed tomography (LDCTs) followed by a potential biopsy if suspicion of cancer remains. Given that the majority of imaged lung nodules are benign, this can lead to unnecessary, invasive procedures.

Due to this, a liquid biopsy capable of determining risk with a non-invasive blood test with diagnostic performance equaling the current SOC could be an alternative.

The assay was previously assessed in 2 studies.

The first, of which the findings were published in Nature, conducted blood and tissue analyses to determine cancer diagnostic approach.2 The investigators re-examined whole genome and whole transcriptome sequencing trials from The Cancer Genome Atlas (TCGA) that included 33 disease types and 18,116 samples in a treatment-naïve population.

Investigators noted that the TCGA signatures stayed predictive in those with stage Ia to IIc disease and those whose disease did not have genomic alterations measured via cell-free DNA platforms. Investigators notably utilized strict decontamination analyses that resulted in them discarding 92.3% of sequence data.

Samples were discriminated against if they came from individuals without cancer (n = 69) and those with multiple types of cancer; this was done through the use of plasma-derived cell-free microbial nucleic acids.

The second study, which was published in Cell, characterized the mycobiomes of 17,041 tissue and blood samples across 4 independent cohorts for 35 cancer types.3 Findings from the study highlighted cancer type–specific fungal ecologies that had lower diversity and abundance compared with matched bacteriomes.

Despite fungi being detected in all disease types assessed in the trial, not every tumor tested positive for fungal signal.

Moreover, imaging indicated that fungi was intracellular within cancer and immune cells and was comparable with tratumoral bacteria. Significant correlations were identified between certain fungi and age, tumor subtype, smoking status, immunotherapy response, and survival.


  1. Micronoma receives FDA breakthrough device designation for OncobiotaLUNG, a novel liquid biopsy assay for lung carcinoma detection. News release. January 10, 2022. Accessed January 13, 2022. http://bit.ly/3IGBzom
  2. Poore DG, Kopylova E, Zhu Q, et al. Microbiome analyses of blood and tissues suggest cancer diagnostic approach. Nature. 2020;579:567-574. doi:10.1038/s41586-020-2095-1
  3. Narunsky-Haziza L, Sepich-Poore GD, Livyatan I, et al. Pan-cancer analyses reveal cancer-type-specific fungal ecologies and bacteriome interactions. Cell. 2022;185(20):3789-3806.e17. doi:10.1016/j.cell.2022.09.005.
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