Introduction

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.

Areas covered

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.

Expert opinion

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.

中文翻译：

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传染病的伴随和补充诊断。

介绍

伴随诊断 (CDx) 在肿瘤学治疗决策中很重要，但官方缺乏经监管机构批准的用于传染病治疗的特定 CDx。虽然未被批准为 CDx，但有几个 ID 诊断被用作 CDx。诊断界、制造商和监管机构做出了重大努力，以确保在新药剂发布时或即将发布时提供新抗菌药物的诊断方法。

覆盖区域

本综述重点介绍了传染病文献中补充和伴随诊断 (c/CDx) 的地位，重点是针对病原体的基因型抗微生物药物耐药性测试作为一类诊断测试。

专家意见

除了当前和新兴技术之外，CRISPR、败血症标志物和窄谱抗菌素也为传染病 c/CDx 提供了机会。挑战包括指南修订缓慢、监管批准成本高、机构长期购买、药物/诊断伙伴关系不一致以及更高的治疗成本。用于治疗不同传染病的患者数量和可用药物非常适合支持竞争性诊断测试。然而，较新的治疗方法（例如，窄谱抗生素）可能非常适合少数患者，即支持 CDx 的利基市场。当前的重点是快速和即时 (POC) 诊断平台以及治疗方法的变化。