Tissue preservation tool for MDx

 描述(由申请人提供)：为了实现分子诊断(MDX)和癌症诊断和疾病研究的个性化治疗的承诺，需要用于固体、组织生物标本保存的创新工具。Spot on Science将开发一种高效且经济高效的固体生物样品保存方法，可以在任何地点进行，同时提高样品的稳定性和分子分析的可及性。在这种方法中，从新切除的组织中收集小样本，并在稳定缓冲液中快速均质。匀浆应用于封闭墨盒内的吸水性纸张，并通过干燥剂快速干燥。一旦干燥，包括核苷酸、蛋白质和小分子在内的分析物在室温下表现出多年的稳定性。利用此前由Spot on Sciences，hemaSpot开发的新型血液采集设备，封闭式血盒可防止样本污染，并允许在环境温度下方便地将其运送到检测实验室，而不需要冷链。该设备预先贴上条形码标签，以简化样品跟踪。基于成熟的干血斑技术，常见的分析方法如RT-PCR、免疫化学和LC-MS/MS与这些干样品高度兼容。HemaSpot设备上的预切纸允许轻松地移除用于分子分析和研究的样品分段。我们实验室的初步数据表明，将组织作为干燥的匀浆保存在滤纸上是可行的。这项研究将进一步探索这些结果，并展示从同一样本中测量包括核苷酸、蛋白质和小分子在内的各种分析物的能力。该项目的最终目标是为护理点(POC)诊断设施提供一个商业工具包，其中包含 所需的试剂和用于收集和存储均质组织样本的简单设备。最低限度的基础设施要求将允许从任何环境中采集样品，包括偏远、农村和低资源地区，同时在各种环境条件下提供稳定、高质量的样品。这种创新的方法将极大地简化和降低生物样品的收集和储存成本，同时增加用于研究的高质量样品的可用性，以及用于癌症患者预后和治疗益处的分子测试。

 DESCRIPTION (provided by applicant): Innovative tools for solid, tissue biospecimen preservation are needed to meet the promise of molecular diagnostics (MDx) and personalized treatment for cancer diagnoses and disease research. Spot On Sciences will develop an efficient and cost-effective method for solid biospecimen preservation that can be performed in any location while improving sample stability and accessibility for molecular analyses. For this method, a small sample is collected from a freshly excised tissue and quickly homogenized in stabilizing buffer. The homogenate is applied to absorbent paper within an enclosed cartridge and rapidly dried by a desiccant. Once dried, analytes including nucleotides, proteins and small molecules show stability at room temperature for years. Leveraging a novel blood collection device previously developed by Spot On Sciences, HemaSpot, the enclosed cartridge prevents sample contamination and allows facile shipment to a testing laboratory at ambient temperature with no cold chain requirements. The device is pre- labeled by bar code for simplified sample tracking. Based on well-established dried blood spot technology, common analytical methods such as RT- PCR, immunochemistry and LC-MS/MS are highly compatible with these dried samples. The pre- cut paper on the HemaSpot device allows for easy removal of sample subsections for molecular analyses and research. Preliminary data in our lab suggests feasibility for tissue to be preserved as a dried homogenate on filter paper. This study will further explore these results and demonstrate capability for measuring a wide range of analytes including nucleotides, proteins and small molecules from the same sample. The ultimate goal for this project is to provide a commercial kit for point of care (POC) diagnostic facilities containing all needed reagents and a simple device for collecting and storing homogenized tissue samples. Minimal infrastructure requirements will allow sample collection from any environment including remote, rural and low resource areas while providing stable, quality samples under a wide range of ambient conditions. This innovative method would greatly simplify and reduce costs for biospecimen collection and storage while increasing availability for high quality samples for research and for molecular testing for prognostic and therapeutic benefit for cancer patients.