The OncobiotaLUNG assay is the first blood microbiome-driven liquid biopsy created to detect lung carcinomas in its earliest stages

January 10, 2023. SAN DIEGO, Calif.–  Micronoma, the first biotech company developing 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), for those who are unsuitable for, refuse, or lack access to a PET-CT. When an imaging test (e.g., low-dose CT scan (LDCT)) shows an indeterminate lung nodule in a patient, the current standard of care is to keep the patient under surveillance with additional imaging (e.g., more LDCTs, PET-CT scans). Then, if suspicion remains, they are sent for a lung biopsy. However, since 95% of imaged lung nodules turn out to be benign, the current patient journey can be a slow and risky one, with invasive but potentially unnecessary tissue biopsies. In contrast, for those who are unsuitable for, refuse, or lack access to a PET-CT, with a simple blood draw, Micronoma’s OncobiotaLUNG diagnostic assay can help clinicians determine a high-risk versus low risk of malignancy for the detected lung nodules.

Early detection of lung cancer can lead to a higher survival rate. In the U.S., lung cancer accounts for nearly 25% of all cancer-related deaths each year, with more people dying from lung cancer than from colon, breast, and prostate cancers combined (source: American Cancer Society).

“Receiving FDA Breakthrough Device Designation is a fantastic recognition by the agency and a great milestone for Micronoma,” said Sandrine Miller-Montgomery, Micronoma CEO and co-founder. “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.”

The work that led to the Breakthrough Device Designation is based on the findings of Micronoma’s co-founders, published in the scientific journals Nature and Cell. These discoveries were then validated in a large, lung-specific cohort, as described in a manuscript shared with the FDA and under review at a high-impact journal.  As a result of the designation, Micronoma can expect continued guidance and prioritized reviews from the agency of its upcoming clinical trial and concomitant pre-market approval processes.

To learn more about Micronoma, please go to


About Micronoma

Micronoma is the first cancer-detection company utilizing signals from some of the most ancient matter in the world, microbial nucleic acids, to empower clinicians to diagnose cancer at an early stage with minimally invasive, microbiome-driven liquid biopsy technology. Micronoma was founded in 2019 by leaders in microbiome research with the goal of revolutionizing and advancing the practice of early cancer diagnostics and personalized treatment through sensitive microbiome techniques, ensuring that patients’ needs are identified and addressed by their clinicians at the earliest stage for a better chance to live longer, healthier lives. The company is headquartered in San Diego, California.