SBIR Phase II: Liquid Biopsy Diagnostic Targeting Novel Extracellular Vesicle Biomarkers

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to improve tools available for cancer detection and diagnoses through a minimally invasive technique. Through improving on standard techniques and utilizing quantifiable biomarker readouts, this project can deliver faster diagnoses, earlier treatment decisions, and more consistent risk stratification. This technology is designed to scale to other hard-to-detect cancers, broadening public health benefit and supporting a durable commercial pathway from laboratory testing to future distributed diagnostics. This Small Business Innovation Research (SBIR) Phase II project advances and validates a tool that measures cancer signals carried by extracellular vesicles (EVs), tiny particles released by tumor cells. These vesicles carry proteins and genetic material that mirror tumor activity, allowing a standard blood sample to capture disease signals without imaging or surgery. EVs appear in the bloodstream earlier and in greater numbers than circulating tumor cells and have been detected at tumor volumes near 1 cm3, supporting detection before symptoms arise. This research will conduct a prospective, blinded study of roughly 300 patients undergoing surgery, comparing test results with the final surgical diagnosis as the reference standard. The study will deliver test sensitivity and specificity and assess performance across age groups and common comorbidities to ensure broad clinical utility. The work will also demonstrate reproducibility and establish rigorous quality controls needed for clinical laboratory use. Analytical testing will confirm stability and precision throughout testing. Finally, the project will use a 3D cell culture discovery system a novel technology to identify additional EV biomarkers. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.