Introduction

The merging of molecular diagnostics with personalized medicine has led to a surge in development of molecular-based companion diagnostics. Companion diagnostics, defined as ‘a medical device, often an in vitro device, which provides information that is essential for the safe and effective use of a corresponding drug or biological product’, are key to the appropriate utilization of several pharmacotherapies; primarily in the area of oncology.

Areas Covered

While most molecular companion diagnostics are targeted toward oncology, the potential to multiplex assays will contribute to an expansion in the applications of companion diagnostics for an increasing menu of disease states and conditions including areas such as infectious disease, cardiology, and hematology.

Expert opinion

With this innovation comes the responsibility to ensure molecular companion diagnostic devices are robust and controlled against the detrimental effects of false positive/negative results. Additional important considerations, such as paired development with pharmaceutical companies and adherence to Food and Drug Administration and/or European Union guidelines, must be addressed. While the current number of companion diagnostics is relatively small, as molecular assays continue to be developed as companion diagnostics the world of personalized medicine will advance to meet the needs of an expanding portion of the patient population.

中文翻译：

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分子伴随诊断的更新——超越 Sanger 测序的个性化医疗的未来。

介绍

分子诊断与个性化医疗的结合导致基于分子的伴随诊断的发展激增。伴随诊断被定义为“一种医疗器械，通常是一种体外器械，它提供对相应药物或生物制品的安全和有效使用至关重要的信息”，是适当利用多种药物疗法的关键；主要在肿瘤学领域。

覆盖区域

虽然大多数分子伴随诊断都针对肿瘤学，但多重检测的潜力将有助于扩展伴随诊断在越来越多的疾病状态和条件菜单中的应用，包括传染病、心脏病学和血液学等领域。

专家意见

随着这项创新，我们有责任确保分子伴随诊断设备的稳健性和可控性，防止假阳性/阴性结果的不利影响。其他重要的考虑因素，例如与制药公司的配对开发以及遵守食品和药物管理局和/或欧盟的指导方针，必须加以解决。虽然目前伴随诊断的数量相对较少，但随着分子检测作为伴随诊断的不断发展，个性化医疗领域将不断发展，以满足越来越多的患者群体的需求。