Roche Pharma Research & Early Development, Nonnenwald 2, 82377 Penzberzg, Germany.
N Biotechnol. 2012 Sep 15;29(6):651-5. doi: 10.1016/j.nbt.2012.03.008. Epub 2012 Mar 30.
Predictive biomarkers are discovered and used in oncology research to formulate hypotheses aimed at the identification of patients benefiting from specific therapeutic intervention(s). They pave the way to the development of companion diagnostic tests which are tools readily implemented in the clinic and serve to qualify a patient for treatment with a particular targeted drug or the continued use of a particular drug, thus maximizing the benefit to risk ratio of the medical intervention to the patient. Predictive biomarkers are defined by biological characteristics of the patient's or tumor status that can be measured objectively and correlated with clinical outcome: these can be molecular, cellular or biochemical features. Predictive markers need extensive analytical validation - specific for the tool utilized for their assessment - as well as rigorous clinical qualification in the context of the drug treatment for which they define clinical utility. The process of companion diagnostic development is a highly interdisciplinary and complex one, driven by key crucial milestones and accompanying the same and typical process of a whole drug discovery and development continuum, from marker discovery and validation, assay development, clinical qualification until test approval and commercialization.
预测生物标志物在肿瘤学研究中被发现和使用，旨在制定旨在识别受益于特定治疗干预措施的患者的假设。它们为伴随诊断测试的开发铺平了道路，这些测试是在临床中易于实施的工具，用于使患者有资格接受特定靶向药物的治疗或继续使用特定药物的治疗，从而使医疗干预对患者的获益风险比最大化。预测生物标志物由患者或肿瘤状态的生物学特征定义，可以客观测量并与临床结果相关联：这些特征可以是分子、细胞或生化特征。预测标志物需要广泛的分析验证 - 针对用于评估它们的工具特定 - 以及在药物治疗背景下的严格临床资格，因为它们定义了临床实用性。伴随诊断开发的过程是一个高度跨学科和复杂的过程，由关键的关键里程碑驱动，并伴随着整个药物发现和开发连续体的相同和典型过程，从标志物发现和验证、检测方法开发、临床资格认证直到测试批准和商业化。
