Clinical Validation of ER/PR Test Controls & Calibrators

ER/PR 测试对照的临床验证

• 批准号: 7110811
• 负责人: Steven A Bogen
• 金额: $ 54.57万
• 依托单位: BOSTON CELL STANDARDS INC
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-03-06 至 2008-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7110811
• 关键词: bioassay; bioengineering /biomedical engineering; biomedical equipment development; biotechnology; clinical biomedical equipment; diagnosis design /evaluation; diagnosis quality /standard; estrogen receptors; human tissue; immunocytochemistry; neoplasm /cancer diagnosis; progesterone receptors; tissue /cell culture

DESCRIPTION (provided by applicant) Phase I The long-term objective of this project is to improve the consistency and standardization of clinical cancer diagnostic testing of tissue biopsies. There are increasing numbers of cancer therapeutics that are linked to immunohistochemical diagnostic tests. Patient therapy is directly affected by the quantitative results of such testing. The absence of quantitative controls and calibrators seriously hampers the ability of laboratories to achieve consistent and standardized test results. Laboratories currently use pathologic discard tissue biopsies as controls, an inherently unstandardized source. In order to address this need, we developed the Analyte Controls technology. It provides an inexpensive, reproducible, and quantitative test material for detecting errors in staining procedure. This program aims to validate the clinical utility of this technology. In addition, this Phase I/Il Fast Track program is expected to lead to an FDA submission. For Phase I, we will address three technical aspects of the technology before launching into clinical trials. The Specific Aims of the Phase I grant are: (1) to create Analyte Controls for three new ER & PR antibodies. With these three, our Analyte Controls Slide will test for all of the commonly used ER and PR antibody clones, which is important prior to initiating clinical trials. (2) Identify Analyte Control peptides for ER and PR testing that distinguish pre-analytic sources of error (i.e., antigen retrieval) from analytic types of error, and (3) to demonstrate feasibility of a clinical laboratory slide densitometer that laboratories can use to quantify optical density of Analyte Controls on microscope slides. A method for precise quantification is required for clinical trials. The Analyte Controls for ER & PR will be the first quantitative control and calibrator for quantitative immunohistochemical testing that can be manufactured in inexhaustible amounts, relatively inexpensively, and in a reproducible fashion.

描述（由申请人提供） 第一阶段 该项目的长期目标是提高组织活检临床癌症诊断检测的一致性和标准化。与免疫组织化学诊断测试相关的癌症治疗方法越来越多。患者治疗直接受到此类测试的定量结果的影响。缺乏定量控制和校准器严重阻碍了实验室获得一致和标准化测试结果的能力。实验室目前使用病理废弃组织活检作为对照，这是一种本质上不标准化的来源。 为了满足这一需求，我们开发了分析物控制技术。它提供了一种廉价、可重复且定量的测试材料，用于检测染色过程中的错误。该计划旨在验证该技术的临床实用性。此外，这一 I/II 期快速通道计划预计将向 FDA 提交申请。对于第一阶段，我们将在启动临床试验之前解决该技术的三个技术问题。第一阶段资助的具体目标是：(1) 为三种新的 ER 和 PR 抗体创建分析物对照。通过这三者，我们的分析物对照载玻片将测试所有常用的 ER 和 PR 抗体克隆，这在开始临床试验之前非常重要。 (2) 鉴定用于 ER 和 PR 测试的分析物对照肽，以区分分析前的误差来源（即抗原修复）和分析类型的误差，以及 (3) 证明临床实验室载玻片光密度计的可行性，实验室可使用该载玻片光密度计来量化显微镜载玻片上分析物对照物的光密度。临床试验需要一种精确定量的方法。 ER 和 PR 分析物对照品将成为定量免疫组织化学测试的第一个定量对照品和校准品，可以以相对便宜的方式以可重复的方式大量生产。