TOPIC NUMBER: 458 SMALL BUSINESS INNOVATION RESEARCH (SBIR) PHASE IONCOBIOMIX: MICROBIOME-BASED TEST FOR PROSTATE CANCER RISK

Prostate cancer (PCa) remains a significant global health challenge, particularly in the United States where it is the most common non-cutaneous cancer among men. The landscape of PCa diagnosis and risk assessment is evolving due to a growing awareness of the limitations and potential harms associated with prostate specific antigen (PSA) screening. While early-stage PCa is highly treatable, overreliance on PSA screening

has led to issues like false positives, unnecessary biopsies, and the overdiagnosis of non-life-threatening PCa. This underscores the pressing need for more precise and reliable risk assessment tools that can improve early detection while minimizing the adverse consequences of screening. Recent research emphasizes the vital role of the human microbiome in cancer initiation and progression.

In this context, Oncobiomix has introduced an innovative microbiome signature score that has the potential to shift the paradigm for PCa risk assessment. This score evaluates the presence and abundance of specific gut microbiota associated with PCa, offering a novel tool compared to traditional PSA testing. This proposal will facilitate development of a stringent CLIA/CAP standard operating procedure for proprietary microbiome signature, thus providing a novel PCa risk assessment approach. Ongoing human testing from this study will expedite clinical

validation and commercialization.