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TEST:
OncobiotaLUNG assay

Company:
Micronoma
Type:
Laboratory Developed Test
Evidence

News

10ms
Development Of A Clinico-Proteo-Metagenomic Classifier For Risk Stratification Of Incidentally-Detected Pulmonary Nodules (IASLC-WCLC 2023)
Cf-mbDNA comprises a novel class of biomarkers that complements host analytes. In a validation cohort, the OncobiotaLUNG test outperformed standard of care on matched individuals to diagnose incidentally-detect pulmonary nodules, leading to FDA Breakthrough Designation. Synergistic performance gains may be further realized with integration of additional cell-free DNA information.
OncobiotaLUNG assay
1year
Micronoma Teams Up with NYU Grossman School of Medicine on Lung Cancer Research Grant Utilizing Microbial Biomarkers (Businesswire)
"Micronoma announced today that it is serving as the industry partner on a grant the NYU Grossman School of Medicine received from the National Cancer Institute to identify microbial and host genomic signatures that can be used with other methodologies to predict non-small cell lung cancer (NSCLC) in its early stages as well as the chance of post-surgical recurrence....With this grant, NYU and Micronoma intend to continue identifying the leading microbial and host biomarkers that can be used to predict early-stage lung cancer diagnosis and prognosis and use cutting-edge bioinformatic mechanisms and potentially targeted molecular tools to pursue developing early-stage testing and prognosis."
Financing
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OncobiotaLUNG assay
1year
Micronoma presents state-of-the-art metagenomic liquid biopsy (Micronoma Press Release)
"Highlighting that cancer is no longer considered a sterile disease, Greg Sepich-Poore, Ph.D., Chief Analytic Officer and Co-founder of Micronoma...shared the company’s impressive diagnostic capabilities in a presentation at the American Association for Cancer Research’s (AACR) annual meeting in Orlando, Florida."
Clinical data
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OncobiotaLUNG assay
over1year
Micronoma receives FDA breakthrough device designation for OncobiotaLUNG, a novel liquid biopsy assay for lung carcinoma detection (Micronoma Press Release)
"Micronoma, the first biotech company offering 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)."
FDA event
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OncobiotaLUNG assay