ABSTRACT

Introduction

The pace of biomarker discovery has increased exponentially over the last few years, ushering in an era of precision medicine (PM) with a growing arsenal of treatments tailored to specific patient populations. To accurately identify patients, companion diagnostics (CDx) are developed and launched alongside these treatments. However, even with a timely launch of therapies and CDx tests, patients are not guaranteed optimal access to these tests because of the inefficiencies embedded within the clinical diagnostic testing landscape supporting PM.

Areas covered

This commentary describes implementation challenges facing CDx tests and delaying clinical uptake. We also assess the ‘siloed thinking’ perpetuating these challenges and propose steps toward resolution. Our research is based on published literature and findings from the Diaceutics proprietary patient testing database.

Expert opinion

The clinical and economic ecosystem underpinning the diagnostic journey of patients remains severely underdeveloped. Patients are denied suitable therapies because of delayed identification or failings in real-world testing deployment. Progress is needed in clinical collaborations, integrator platforms, economic value sharing, and ownership of the patient testing journey to PM. We need to consider that better precision testing will deliver an equal or greater outcome to patients than new precision treatments alone.

中文翻译：

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精准医学伴随诊断临床实施的挑战。

摘要

介绍

在过去几年中，生物标志物发现的步伐呈指数级增长，迎来了精准医学 (PM) 时代，针对特定患者群体量身定制的治疗方案不断增加。为了准确识别患者，伴随这些治疗方法开发并推出了伴随诊断 (CDx)。然而，即使及时启动治疗和 CDx 测试，由于支持 PM 的临床诊断测试环境中嵌入的低效率，也不能保证患者获得最佳访问这些测试的机会。

覆盖区域

该评论描述了 CDx 测试和延迟临床应用面临的实施挑战。我们还评估了使这些挑战长期存在的“孤立思维”，并提出解决方案。我们的研究基于已发表的文献和 Diaceutics 专有患者测试数据库的发现。

专家意见

支撑患者诊断旅程的临床和经济生态系统仍然严重不发达。由于延迟识别或实际测试部署失败，患者被拒绝接受合适的治疗。需要在临床合作、集成平台、经济价值共享和患者检测到 PM 的过程中取得进展。我们需要考虑到，与单独的新精确治疗相比，更好的精确测试将为患者带来相同或更好的结果。