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

这个小型企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力旨在改善癌症的诊断和治疗。 癌症影响着数百万美国人和世界各地的人们。美国国家癌症研究所（NCI）报告说，到2040年，新的癌症病例将达到3000万，这对美国社会和经济来说是一个巨大的成本。迫切需要分子诊断和个性化医疗等创新技术来对抗癌症。聚合酶链反应（PCR）和下一代测序（NGS）等现代分子检测方法通常存在肿瘤含量低和样本中非癌细胞遗传污染的问题，导致DNA含量不足，无法进行准确的分子检测。 这项研究将集中在显微切割作为一种手段，获得癌细胞进行测试。拟议的肿瘤细胞纯化和提取将使该公司能够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，数学优化和真实世界的实验验证，这将大大有助于临床实验室仪器和配套产品的成功商业化。这个小型企业创新研究（SBIR）第一阶段项目旨在进行科学研究，以了解显微切割过程中发生的光学，热和机械相互作用。由此产生的建模将用于从患者活检样本中可靠地提取癌细胞，考虑不同的样本类型和癌细胞染色强度。显微切割从人体样本中纯化癌细胞，并进行分子检测和基因分析。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。在这个项目中，目的是进行研究，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）。这项技术将用于确定成功显微解剖组织标本和开发用于研究和商业临床实验室使用的仪器的具体操作规范。该奖项反映了NSF的法定使命，并被认为值得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来支持。

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.