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06 Feb 2023 - 09 Feb 2023

Blood Microbiome-Driven Liquid Biopsy Assay Detects Lung Cancer in Earliest Stages

By LabMedica International staff writers
Posted on 11 Jan 2023
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Image: The OncobiotaLUNG assay for lung carcinoma detection has received FDA Breakthrough Device Designation (Photo courtesy of Pexels)
Image: The OncobiotaLUNG assay for lung carcinoma detection has received FDA Breakthrough Device Designation (Photo courtesy of Pexels)

Early detection of lung cancer can lead to a higher survival rate. 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 potentially invasive but unnecessary tissue biopsies. Now, the first blood microbiome-driven liquid biopsy with proven effectiveness can identify lung cancer in its earliest stages.

Micronoma’s (San Diego, CA, USA) OncobiotaLUNG assay is based on the company’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. A traditional liquid biopsy usually refers to a test done on a sample of blood to look for one or more genetic biomarker(s) associated with a cancer, such as methylation or fragmentation profile of genetic materials isolated from circulating tumor cells (CTC) and/or cell-free DNA that is shed from the tumor. However, these types of genetic biomarkers are more easily detected for large tumors, which makes such methods less efficient for detecting cancer at its earliest stages.

Micronoma focuses on the circulating microbial nucleic acid signatures, or microbiome biomarkers, that are associated with the tumor and the body’s response to the developing tumor. Importantly, and based on published data, these microbial signals do not seem to be dependent on tumor size, potentially enabling its proprietary platform to detect cancer at an earlier stage of cancer development. Micronoma’s patent-pending method, analyzing a multitude of circulating microbial markers linked to the tumor tissue as well as the host response to the cancer, has the potential to provide an advantage in early-stage cancer detection. Micronoma’s OncobiotaLUNG assay has received the Breakthrough Device Designation from the Food and Drug Administration (FDA)

“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,” said Sandrine Miller-Montgomery, Micronoma CEO and co-founder. “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.”

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