Target product profiles in laboratory medicine: a framework for defining test requirements and supporting outcome-based performance specifications

Abstract

Despite rapid advances in diagnostics, many tests fail to deliver meaningful clinical or system value because their intended use, performance requirements, and implementation context were not clearly articulated early in development. Target product profiles (TPPs) offer a structured, consensus-based framework to define intended use, outline minimal and desirable performance specifications, and set operational expectations for testing technologies. This paper introduces the topic of TPPs, summarising their purpose, structure, and typical development pathways. We describe a three-phase development process of scoping, drafting, and consensus-building, and use real-world examples to illustrate how evidence, stakeholder input, and contextual constraints shape the specification of performance requirements. We highlight how TPPs can support the shift toward outcome-based performance specifications by providing a transparent mechanism to link test analytical and clinical performance with downstream clinical decision-making, patient outcomes, and system-level impact. We also propose strategies to strengthen the methodological robustness and transparency of TPPs and emphasise the essential role laboratory professionals play in ensuring feasibility and clinical relevance of TPP content. When developed collaboratively, including essential laboratory input, TPPs serve as practical tools that guide upstream test research and design and support ongoing verification, validation and life-cycle management, helping to ensure that tests are clinically meaningful, operationally implementable, and responsive to real-world healthcare needs. Ultimately, the integration of well-designed TPPs into test development pipelines has the potential to accelerate innovation that delivers real clinical value and strengthens the role of laboratory medicine in improving patient outcomes.