The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to improve personalized cancer care by developing a first in class cancer diagnostic instrument that can deliver clinically actionable, personalized, drug response data from individual cancer patients using the E-slice assay. The E-slice assay is a novel 3D culture-based assay which has been shown to accurately predict individual cancer patients? responses to treatments. The E-slice assay is currently registered as a Clinical Laboratory Improvement Amendments Laboratory Developed Tests (CLIA LDT). The cancer diagnostic market is expected to grow from $56 billion in 2022 to $162 billion by 2027, and this test and automation could capture a significant share of this rapidly expanding market. Beyond improving outcomes for cancer patients, the automation of this assay could have far-reaching implications, such as accelerating and economizing drug screening, discovery, and development for pharmaceutical and biotechnology companies, and academia.This Small Business Innovation Research (SBIR) Phase I project addresses the most challenging and risky portion of automating the E-slice assay. The novel engineering solutions that the team proposes to develop will automate the processing of live human tissue samples from a needle biopsy or surgery, generate precision-cut slices, and then precisely position them in a tissue culture plate for downstream culture and analysis. The new device will do so in a manner that maintains sterility, minimizes thermal, chemical, and mechanical stresses, and performs in a highly reliable way. The primary technical challenges are ensuring reliable performance that is equal to or superior than manual methods. The technical milestones include meeting thresholds for reliability, sterility, and tissue viability compared to manual processing.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.
