Developing a patient-focused target product profile (TPP) to accelerate the diagnosis of chronic lung conditions
The Simple Lung Test TPP will establish a blueprint for the development of tests to diagnose or triage patients suspected of chronic lung conditions, ensuring new tests meet the needs and priorities of those affected.
Overview
According to Asthma + Lung UK, approximately 12 million people (one in 5 in the UK population) will develop a lung condition during their lifetime, often facing barriers to proper diagnosis and treatment. In November 2023 we held a workshop with Asthma + Lung UK with diverse stakeholders across the respiratory diagnostics sector. Outputs from this workshop identified 4 priority areas where new tests to accelerate diagnoses are needed:
- Lung health indicator: at home or community use.
- Diagnostics in primary care: diagnose conditions or triage to secondary care.
- Patient stratification: distinguish by endotype to guide treatment
- Exacerbation detection: self-monitoring, patient-centric
A ‘test’ refers to a diagnostic procedure, tool, or solution used to identify and assess chronic respiratory conditions. This could encompass software or AI-driven solutions, wearable devices, as well as traditional methods like spirometry or peak flow tests.
The Simple Lung Test TPP will focus on priority area 2: diagnostics in primary care. Building on our experience and knowledge in developing patient-focused TPPs for other indications, we will collaborate with experts in developing the Simple Lung Test TPPs.
What is a target product profile (TPP)?
A target product profile (TPP) is a ‘blueprint’ for developers, outlining the characteristics a test should have to address a specific need. By presenting information on the scope, design, performance and operational requirements, TPPs guide diagnostic developers from early research and innovation through to integration into healthcare systems.
Why is a Simple Lung Test TPP needed?
Diagnosis of chronic lung conditions such as asthma, bronchiectasis, COPD and interstitial lung disease are often significantly delayed, with patients waiting years or even decades from the onset of symptoms to diagnosis. This diagnostic delay is partly due to the absence of simple, acceptable tools tailored for use in primary care (e.g., GP surgery) that can either diagnose the underlying condition or triage patients for additional assessment.
Current diagnostic pathways often rely on specialist assessments or cumbersome procedures that are not always feasible in primary care settings, leading to missed opportunities for early intervention. Early diagnosis improves patient outcomes by providing access to appropriate treatment, support and disease management.
Aims and impact of the Simple Lung Test TPP
Define desirable diagnostic profiles
Establish clear, patient-centred standards for lung condition tests, outlining both desirable and minimally acceptable criteria.
Focus on patient needs
Ensure the test development process prioritises accessibility, accuracy and relevance to patients’ everyday health challenges.
Guide test development
Provide a foundation for developing patient-focused diagnostic tools that can integrate into healthcare systems and serve diverse patient populations.
Stimulate innovation
Foster collaboration and consensus on future diagnostic priorities, steer industry efforts and shape funding opportunities to accelerate translational research.
Simple Lung Test TPP development roadmap:
Phase 1: scoping and landscaping
- We are working to understand current care and unmet needs in diagnosing lung conditions by reviewing the current guidelines surrounding diagnoses and holding a clinical and lived experience focus group.
Phase 2: drafting and refinement
- Our initial draft of the TPP will be based on focus group outputs. Using this draft, we will engage in wide-ranging stakeholder discussions and refine the TPP to align with feedback.
Phase 3: consensus building
- We will confirm the agreed TPP characteristics by seeking broad input from a relevant stakeholder group via surveys and workshops.
Phase 4: launch
- We aim to launch and disseminate the Simple Lung Test TPP in Q4 2025.
We want to hear from you
We are looking for stakeholders to participate in workshops, surveys and focus groups. Please reach out If you have lived experience of chronic lung conditions or work in primary care, respiratory medicine, diagnostic development or related areas.
