Target Product Profiles for Diagnostics
TPP for Diagnostics project will deliver Target Product Profiles to catalyse and guide development of diagnostics to detect and manage CF lung infections.
The project is being delivered through the complementary expertise of 4 organisations – LifeArc, the NIHR Newcastle In Vitro Diagnostics Co-operative (‘Newcastle-MIC’), Medicines Discovery Catapult and the Cystic Fibrosis Trust in partnership with the wider global community.
In addition to new antimicrobials, diagnostics are needed to both predict when infections will cause pulmonary exacerbations and to avoid unnecessary use of antibiotics. Current diagnostic practice in CF is centred on the detection of pathogens from sputum or cough swabs through standard culture techniques and in vitro antibiotic susceptibility testing. Generally this is done either as part of surveillance during routine outpatient checkups, or as part of a series of investigations during and following acute pulmonary exacerbations. There are however limitations to this which include:
- Turnaround of diagnostic microbiology results can be slow.
- Current methodology fails to detect emerging pathogens.
- The presence of a specific pathogen doesn’t necessarily inform treatment/clinical practice.
- With the advent of highly effective modulator therapy, sputum is less readily available for diagnostic testing.
There are therefore opportunities to bring about improvements in diagnosis for lung infections in CF.
The TPPs developed through this project aim to outline the necessary characteristics of a diagnostic to address the need in better managing lung infections in CF and shall act as a guiding document for development and manufacture of new tests that can aid clinical research, including clinical trials of therapeutics, and ultimately be readily adopted into clinical practice for decision-making. It is anticipated that this work will catalyse new research projects and investment into novel diagnostic tests for lung infections in CF.
The project is being led and funded by LifeArc in collaboration with the NIHR Newcastle In Vitro Diagnostics Co-operative, the Medicines Discovery Catapult and the Cystic Fibrosis Trust.
The TPPs will be developed through delivery of three interlinked work packages;
- A systematic review of all currently available diagnostic tests used and in development for identifying lung infections in CF
- A scoping exercise to define the unmet need, key characteristics and priorities for diagnostics – delivered through listening first to the CF community to understand their needs, then subsequently listening to clinical teams, industry partners and other experts in the field
- A formal TPP elicitation exercise where we will work with all relevant stakeholders broadly across the company to build consensus on the final produced Target Product Profiles
We anticipate the final documents will be ready for publication and dissemination to the community in 2024.