TEST:

OncobiotaLUNG assay

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.

"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."

"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."

"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)."