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

这个小型企业创新研究(SBIR)第一阶段项目的更广泛的影响/商业潜力是通过开发一流的癌症诊断工具来改善个性化癌症治疗，该工具可以使用E-Slice分析提供来自癌症患者个体的临床可操作的个性化药物反应数据。E切片分析是一种新的基于3D培养的分析方法，已被证明可以准确地预测癌症患者对治疗的反应。E-Slice检测目前注册为临床实验室改进修正实验室开发测试(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能会在这个快速扩张的市场中占据相当大的份额。除了改善癌症患者的预后外，该检测的自动化可能具有深远的影响，例如加快和节约制药和生物技术公司以及学术界的药物筛选、发现和开发。这个小型企业创新研究(SBIR)第一阶段项目解决了自动化E-Slice检测最具挑战性和风险的部分。该团队建议开发的新型工程解决方案将自动处理来自针刺活检或手术的活体人体组织样本，生成精确切割的切片，然后将它们精确定位在组织培养板中，用于下游培养和分析。新设备将以一种保持无菌、将热、化学和机械应力降至最低的方式来实现这一点，并以高度可靠的方式运行。主要的技术挑战是确保与手动方法相同或更好的可靠性能。与人工处理相比，技术里程碑包括达到可靠性、无菌和组织活性的阈值。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势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.