Clinical Validation of ER/PR Test Controls & Calibrators

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测试的一致性和标准化。越来越多的癌症治疗与免疫组织化学诊断测试有关。这种检测的定量结果直接影响患者的治疗。缺乏定量控制和校准器严重阻碍了实验室实现一致和标准化测试结果的能力。实验室目前使用病理组织活检作为对照，这是一种固有的非标准化来源。 为了满足这一需求，我们开发了分析控制技术。它为检测染色过程中的错误提供了一种廉价、可重复性和定量的测试材料。该计划旨在验证这项技术的临床实用价值。此外，这一I/Il阶段快速通道计划预计将导致FDA提交。对于第一阶段，在进入临床试验之前，我们将解决该技术的三个技术方面。第一阶段赠款的具体目标是：(1)为三种新的ER和PR抗体创建分析对照。有了这三个，我们的分析控制幻灯片将测试所有常用的ER和PR抗体克隆，这在启动临床试验之前是很重要的。(2)确定用于ER和PR测试的分析控制多肽，以区分分析前错误来源(即抗原修复)和分析错误类型，以及(3)证明临床实验室载玻片密度计的可行性，实验室可以使用该密度计来量化显微镜载玻片上分析控制的光密度。临床试验需要一种精确的定量方法。 ER和PR的分析控制将是第一个定量免疫组织化学检测的定量控制和校准器，可以以取之不尽的数量、相对低廉的成本和可重复的方式生产。

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.