Development of biopsy devices for improved preservation of multiple biopsy tissue samples

项目摘要 如果生物标志物可以被用于医学诊断和治疗，那么分子医学有望促进医学诊断和治疗。 在组织例如肿瘤中准确评估。该项目的长期目标是， 市场新的工具，更好的活检组织采集，处理和存储。第一种新的活检装置旨在 将多个样本采集到盒中并在活检组织样本被切割后不久稳定活检组织样本， 从而防止由于切除组织中的局部缺血而引起的生物标志物水平的变化 样品第二种新的活检设备旨在将组织样本分成两部分， 这将最佳地保持组织的组织学（例如福尔马林固定）， 将最佳地维持组织中的生物标志物水平（例如冷冻）。 该第一阶段项目的具体目标是开发一种原型芯活检装置， 通过单针插入进行样本采集;开发真空辅助活检装置， 短期保存组织样本的模式保存;并比较组织学切片和 原型活检器械与临床级活检器械实现的生物标志物质量 保留组织形态并稳定细胞生物分子特征的活检方法 在活组织检查样品中，预期用于许多临床和研究应用， 商业市场。特别地，这样的装置可以用于监测靶向治疗的效果，并 通过使用针对特定患者的个体化治疗来改善患者的管理 每个患者的患病组织的特征。

Project Summary Molecular medicine holds promise for advancing medical diagnosis and treatment if biomarkers can be accurately assessed in tissues, for example in tumors. The long-term objective of the project is to bring to market new tools for better biopsy tissue acquisition, processing and storing. A first new biopsy device aims to acquire multiple samples into a cartridge and to stabilize the biopsy tissue samples shortly after they are cut, for example by freezing, and thus prevent changes in biomarker levels due to ischemia in the excised tissue samples. A second new biopsy device aims to split the tissue samples into two parts, to store one part in a way that will optimally maintain the histology of the tissue (e.g. formalin fixation) and the second part in a way that will optimally maintain the biomarker levels in the tissue (e.g. freezing). The specific aims of this Phase I project are to develop a prototype core biopsy device for sequential, multiple samples acquisition through a single needle insertion; to develop vacuum-assisted biopsy device with dual- mode preservation for short term storage of the tissue samples; and to compare histology sections and biomarkers qualities as achieved by the prototype biopsy devices versus clinical-grade biopsy device A biopsy methodology that preserves the tissue morphology and stabilizes the biomolecular profile of the cells in the biopsy samples is expected to be used for many clinical and research applications and to achieve wide commercial market. In particular, such a device can be used to monitor the effect of targeted treatment and to improve the management of patients by the use of individualized therapy that targets the specific characteristics of the diseased tissue in each patient.