Department of Immunology, Genetics and Pathology, Science for Life Laboratory, Rudbeck Laboratory, Uppsala University, SE-75185 Uppsala, Sweden.
N Biotechnol. 2012 Sep 15;29(6):634-40. doi: 10.1016/j.nbt.2012.05.004. Epub 2012 May 24.
The heterogeneous nature of cancer results in highly variable therapeutic responses even among patients with identical stages and grades of a malignancy. The move towards personalised medicine in cancer therapy has therefore been motivated by a need to customise therapy according to molecular features of individual tumours. Companion diagnostics serves to support early drug development, it can provide surrogate markers in clinical trials, and also guide selection of individual therapies and monitoring of responses in routine clinical care. The era of companion diagnostics can be said to have begun with the introduction of the HercepTest - a first-of-a-kind diagnostic tool developed by DakoCytomation in 1998 to select patients for therapy with the anticancer drug Herceptin (trastuzumab). Herceptin and the paired test proved that companion diagnostics can help guide patient-tailored therapies. We will discuss herein technologies to analyse companion diagnostics markers at the level of DNA, RNA or protein, focusing on a series of methods developed in our laboratory that can facilitate drug development and help stratify patients for therapy.
癌症的异质性导致即使在具有相同阶段和分级的恶性肿瘤患者中，治疗反应也存在高度的可变性。因此，癌症治疗中向个体化医学的转变是出于根据个体肿瘤的分子特征定制治疗的需要。伴随诊断有助于支持早期药物开发，它可以在临床试验中提供替代标志物，也可以指导个体化治疗的选择和常规临床护理中对反应的监测。伴随诊断的时代可以说是从 1998 年由 DakoCytomation 开发的 HercepTest 开始的，这是第一个用于选择曲妥珠单抗（赫赛汀）抗癌药物治疗的诊断工具。赫赛汀和配对检测证明了伴随诊断可以帮助指导针对患者的治疗。我们将在此讨论在 DNA、RNA 或蛋白质水平分析伴随诊断标志物的技术，重点介绍我们实验室开发的一系列方法，这些方法可以促进药物开发并帮助为治疗分层患者。
