Dailey Peter J, Elbeik Tarek, Holodniy Mark
School of Public Health, University of California, Berkeley , Berkeley, CA, USA.
The Foundation for Innovative New Diagnostics (FIND) , Geneva, Switzerland.
Expert Rev Mol Diagn. 2020 Jun;20(6):619-636. doi: 10.1080/14737159.2020.1724784. Epub 2020 Feb 13.
Companion diagnostics (CDx) are important in oncology therapeutic decision-making, but specific regulatory-approved CDx for infectious disease treatment are officially lacking. While not approved as CDx, several ID diagnostics are used as CDx. The diagnostics community, manufacturers, and regulatory agencies have made major efforts to ensure that diagnostics for new antimicrobials are available at or near release of new agents.
This review highlights the status of Complementary and companion diagnostic (c/CDx) in the infectious disease literature, with a focus on genotypic antimicrobial resistance testing against pathogens as a class of diagnostic tests.
CRISPR, sepsis markers, and narrow spectrum antimicrobials, in addition to current and emerging technologies, present opportunities for infectious disease c/CDx. Challenges include slow guideline revision, high costs for regulatory approval, lengthy buy in by agencies, discordant pharmaceutical/diagnostic partnerships, and higher treatment costs. The number of patients and available medications used to treat different infectious diseases is well suited to support competing diagnostic tests. However, newer approaches to treatment (for example, narrow spectrum antibiotics), may be well suited for a small number of patients, i.e. a niche market in support of a CDx. The current emphasis is rapid and point-of-care (POC) diagnostic platforms as well as changes in treatment.
伴随诊断（CDx）在肿瘤治疗决策中很重要，但目前官方缺乏专门针对传染病治疗的、获得监管批准的CDx。虽然未被批准为CDx，但有几种传染病诊断方法被用作CDx。诊断学界、制造商和监管机构已做出重大努力，以确保在新型抗菌药物上市或即将上市时能有相应的诊断方法。
本综述重点介绍了传染病文献中补充和伴随诊断（c/CDx）的现状，特别关注针对病原体的基因型抗菌药物耐药性检测作为一类诊断测试的情况。
除了现有和新兴技术外，CRISPR、脓毒症标志物和窄谱抗菌药物为传染病c/CDx带来了机遇。挑战包括指南修订缓慢、监管批准成本高昂、机构审批时间长、制药/诊断合作关系不一致以及治疗成本增加。用于治疗不同传染病的患者数量和可用药物数量很适合支持竞争性诊断测试。然而，新的治疗方法（例如窄谱抗生素）可能更适合少数患者，即支持CDx的小众市场。当前的重点是快速和即时检测（POC）诊断平台以及治疗方法的改变。
