SBIR Phase I: A cancer diagnostic instrument to measure empirical treatment response

这项小企业创新研究（SBIR）一期项目的更广泛影响/商业潜力是通过开发一种一流的癌症诊断仪器来改善个性化的癌症治疗，该仪器可以使用E-slice法从个体癌症患者那里提供临床可操作的、个性化的药物反应数据。e切片试验是一种新型的基于三维培养的试验，已被证明可以准确预测个体癌症患者对治疗的反应。e切片检测目前注册为临床实验室改进修订实验室开发测试（CLIA LDT）。癌症诊断市场预计将从2022年的560亿美元增长到2027年的1620亿美元，这种测试和自动化可以在这个快速扩张的市场中占据重要份额。除了改善癌症患者的治疗效果外，该检测的自动化还可能产生深远的影响，例如为制药和生物技术公司以及学术界加速和节省药物筛选、发现和开发。这个小企业创新研究（SBIR）第一阶段项目解决了自动化e切片分析中最具挑战性和风险的部分。该团队提出开发的新型工程解决方案将自动处理针活检或手术中的活体人体组织样本，生成精确切割的切片，然后将其精确定位在组织培养板上，用于下游培养和分析。新设备将以保持无菌，最小化热，化学和机械应力的方式进行，并以高度可靠的方式运行。主要的技术挑战是确保可靠的性能等于或优于手动方法。与手工处理相比，技术里程碑包括满足可靠性、无菌性和组织活力的阈值。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

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.