Working with the Cystic Fibrosis community, we have produced a document to guide future diagnostic research and development.

Problem

Cystic fibrosis (CF) affects about 11,000 people in the UK. People living with CF experience “flare-ups” when symptoms suddenly worsen. This can lead to frequent lung infections that over time can lead to poorer lung function. There are also challenges with methods for detecting lung infections in people with CF.

Action

• We collaborated with the CF Syndicate in Antimicrobial Resistance, comprising of CF Trust, Medicines Discovery Catapult and LifeArc, to steer the development of new diagnostics for people living with CF.
• We reviewed current diagnostic practice and diagnostic tools in use and under development.
• Through focus groups, interviews, surveys and a symposium we consulted with over 150 patients, industry experts, clinicians, university researchers and charity representatives as part of the project.

Outcome

• We reviewed current diagnostic practice, diagnostic tools in use and ones under development that detect and manage lung infections in patients living with CF.
• We facilitated focus group discussions with the CF community including patients with CF. Data gathered here helped to define unmet needs and priorities.
• We also interviewed clinical microbiologists, industry experts and CF clinicians to shape the findings.
• We drafted blueprints, known as “Target Product Profiles” (TPPs), that outline the key attributes that new diagnostics would need to have so they meet the needs of patients and the NHS.
• We refined the guidance document through additional interviews, a symposium and a survey to gain consensus.
• We have published the guidance document containing the “Target Product Profiles” to inform research and development for new diagnostics.
• Our insight panel were involved throughout the project to provide a wider public perspective. This included reviewing patient facing documents and a draft version of our guidance document.

Impact

• The guidance document is intended to serve as a tool for innovators and help focus future diagnostic research and development.
• We have had discussions with teams within The National Institute for Health and Care Excellence (NICE) to determine how this guidance document will guide adoption and appraisal processes for CF diagnostics.
• We have shared our findings with organisations that are driving access to reliable diagnostics across the world such as the World Health Organisation (WHO) and FIND.

Access our scoping literature review

Access the report on the focus groups we conducted

Request a copy of the Diagnostic TPPs