FDA Grants Breakthrough Device Designation to OncobiotaLUNG Assay for Lung Cancer Detection


The FDA has granted the OncobiotaLUNG assay a breakthrough device designation for the early detection of lung cancer.

The FDA has provided the OncobiotaLUNG assay a breakthrough device designation, according to the device maker, Micronoma.1

The OncobiotaLUNG assay is microbiome-driven liquid biopsy platform used for the early detection of lung cancer. The device categorizes lung nodule samples into those that are considered high or low-risk for malignancy based off of a blood draw from the patient. According to the new designation, the company is expecting prioritized reviews from the agency regarding upcoming trials further analyzing the effectiveness of the assay.

The current standard of care to detect lung cancer is to keep a patient under surveillance after an imaging test shows an indeterminate lung nodule, followed by additional imaging. If the suspicion increases, a patient would then be sent for a lung biopsy. The OncobiotaLUNG assay would require a blood draw to determine the risk factor of the nodule. According to Micronoma, the liquid assay has a diagnostic performance that either matches or exceeds the current biopsy standard of care.

Currently, initial findings that led to the FDA’s breakthrough device designation were validated in a large lung cancer specific cohort of patients. A manuscript of the data was shared with the FDA and under a review at a high-impact journal not named the press release.

The initial findings, co-authored by Sandrine Miller-Montgomery and the rest of the Micronoma co-founders, showed the benefit with microbiome analyses of blood and tissue samples that suggested a diagnostic approach which could help detect cancers early.2

Whole-genome and whole-transcriptome sequencing studies were re-examined in The Cancer Genome Atlas (TCGA) from 33 types of cancer in a total of 18,116 samples of treatment naïve patients. They found unique microbial signatures in both tissue and blood samples among the most major types of cancer. The blood signatures then remained predictive of disease for patients with stage I to stage IIa. According to the research, findings suggest there are widespread associations between specific microbiota across multiple cancer types and the potential for a diagnosis.

By looking at these, the OncobiotaLUNG assay can determine the risk factor of a nodule while providing a minimally invasive way of collecting the information compared with the standard of care biopsy in lung cancer. However, more widespread research is warranted beyond the FDA’s newest designation.

“Receiving FDA Breakthrough Device Designation is a fantastic recognition by the agency and a great milestone for Micronoma,” said Sandrine Miller-Montgomery, chief executive officer of Micronoma and co-founder, in a press release. “While I have always had the utmost trust and admiration for my team, this is an objective recognition of the great science and rigorous work they have been conducting. The possibilities for the Oncobiota platform are endless, and while we are starting with lung cancer, we have active collaborations to pursue other cancer types for which early detection is critically unavailable. This designation is our first opportunity to expedite what we set out to do at our inception: significantly contribute to improving cancer patient care through early diagnosis.”


1. Micronoma receives FDA breakthrough device designation for OncobiotaLUNG, a novel liquid biopsy assay for lung carcinoma detection. Micronoma. January 10, 2023. Accessed January 11, 2023. https://bwnews.pr/3w2h5Pn

2. Poore GD, Kopylova E, Zhu Q, et al. Microbiome analyses of blood and tissues suggest cancer diagnostic approach. Nature. 2020 Mar;579(7800):567-574. doi:10.1038/s41586-020-2095-1

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