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

项目摘要 分子医学有望促进医学诊断和治疗，如果生物标记物可以 在组织中进行准确评估，例如在肿瘤中。该项目的长期目标是实现 销售新的工具，以便更好地获取、处理和存储活检组织。第一个新的活组织检查设备旨在 将多个样本采集到盒中并在切片组织样本被切割后不久使其稳定， 例如通过冷冻，从而防止由于切除组织中的缺血而引起的生物标记物水平的变化 样本。第二种新的活组织检查设备旨在将组织样本分成两部分，以某种方式存储其中一部分 这将最佳地保持组织的组织学(例如，福尔马林固定)，并以一种 将以最佳方式保持组织中的生物标记物水平(例如，冷冻)。 这一阶段项目的具体目标是开发一种用于顺序、多个 通过单针插入采集样本；开发双针真空辅助活检装置 组织标本的短期保存模式；并比较组织学切片和 原型活检装置与临床级活检装置所获得的生物标志物质量 一种保留组织形态并稳定细胞生物分子图谱的活组织检查方法 在活检样本中有望用于许多临床和研究应用，并实现广泛 商业市场。具体地说，这种装置可用于监测靶向治疗的效果并 通过使用针对特定患者的个性化治疗来改善患者的管理 每个患者的病变组织的特征。

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.