Department of Laboratory Medicine and Pathology, Mayo Clinic , Rochester, MN, USA.
Expert Rev Mol Diagn. 2020 Jun;20(6):637-644. doi: 10.1080/14737159.2020.1743177. Epub 2020 Mar 19.
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.
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.
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.
分子诊断与个性化医疗的融合促使基于分子的伴随诊断技术得到了迅猛发展。伴随诊断是指“为安全有效使用相应药物或生物制品提供信息的医疗器械，通常是体外诊断设备”，它是合理应用多种药物疗法的关键，主要集中在肿瘤学领域。
虽然大多数分子伴随诊断针对的是肿瘤学，但多重检测的潜力将有助于扩大伴随诊断在不断增加的疾病状态和病症中的应用，包括传染病、心脏病学和血液学等领域。
随着这一创新的出现，必须承担起确保分子伴随诊断设备稳健且不受假阳性/阴性结果不利影响的责任。必须考虑其他重要因素，如与制药公司的配对开发，以及遵守美国食品和药物管理局和/或欧盟的指南。虽然目前伴随诊断的数量相对较少，但随着分子检测继续作为伴随诊断开发，个性化医疗的世界将不断发展，以满足不断扩大的患者群体的需求。
