SBIR Phase I: Microdissection Optimization for Molecular Profiling and Clinical Lab Use

这项小企业创新研究（SBIR）第一阶段项目的广泛影响/商业潜力旨在改善癌症的诊断和治疗。癌症影响着数百万美国人和全世界的人们。美国国家癌症研究所（NCI）报告称，到2040年，新的癌症病例数量将达到3000万，这对美国社会和经济来说是一笔巨大的成本。我们迫切需要分子诊断和个性化医疗等创新技术来对抗癌症。现代分子检测方法，如聚合酶链反应（PCR）和下一代测序（NGS），往往存在样本中肿瘤含量低和非癌细胞遗传污染的问题——导致用于精确分子检测的DNA数量不足。这项研究将集中于显微解剖作为一种获取癌细胞进行测试的手段。拟议的肿瘤细胞纯化和提取将使公司专注于个性化癌症治疗的建模和优化，而不是非癌细胞。该解决方案结合了数学建模、数学优化和现实世界的实验验证，将为临床实验室仪器和补充产品的成功商业化做出重大贡献。这项小型企业创新研究（SBIR）第一阶段项目旨在开展科学研究，以了解微观解剖过程中发生的光学、热和机械相互作用。由此产生的模型将用于从患者活检样本中可靠地提取癌细胞，考虑到不同的样本类型和癌细胞染色强度。显微解剖从人类样本中纯化癌细胞，使分子测试和基因分析成为可能。目前用于肿瘤细胞纯化和提取的仪器要么费力，要么不可靠。本项目旨在通过考虑常见的组织变化（即组织类型、组织厚度和染色强度），对显微解剖的光热力学相互作用进行建模和优化研究。这项技术将用于确定成功显微解剖组织标本的具体操作规范，并开发用于研究和商业临床实验室使用的仪器。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 aims to improve cancer diagnosis and treatment. Cancer affects millions of Americans and people worldwide. The National Cancer Institute (NCI) reports that the number of new cancer cases will reach 30 million by 2040, representing an enormous cost to American society and the economy. There is a dire need for innovative technologies such as molecular diagnostics and personalized medicine to combat cancer. Modern molecular testing methods such as polymerase chain reaction (PCR) and next-generation sequencing (NGS) often suffer from low tumor content and genetic contamination from non-cancer cells contained in their samples - resulting in an insufficient amount of DNA for accurate molecular testing. This research will focus on microdissection as a means of obtaining cancer cells for testing. The proposed tumor cell purification and extraction will enable the company to focus on modelling and optimalization of individualized cancer treatments rather than non-cancer cells. The solution combines mathematical modeling, mathematical optimization, and real-world experimental verification which will contribute significantly to successful commercialization of clinical lab instruments and complementary products. This Small Business Innovation Research (SBIR) Phase I project aims to conduct scientific research to understand the optical, thermal, and mechanical interactions that occur during microdissection. The resulting modeling will be used to enable reliable extraction of cancer cells from patient biopsy samples, accounting for different sample types and cancer-cell stain intensities. Microdissection purifies cancer cells from human samples and enables molecular testing and genetic profiling. Current instruments for tumor cell purification and extraction are either arduous or unreliable. In this project, the aim is to conduct research to model and optimize the opto-thermal-mechanical interaction of microdissection by taking into consideration common tissue variations (i.e., tissue types, tissue thickness, and stain intensity). This technology will be used to determine the specific operating specifications for successfully micro-dissecting tissue specimens and developing an instrument for research and commercial clinical laboratory use.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.