How will biomarker-led diagnostics reshape respiratory medicine?
pharmafile | October 11, 2026 | Feature | |Â Â Asthma & COPD, COPD, Chronic Diseases, Diagnostics, biomarkers, clinical trialÂ
By Dr Louise Ryan Murphy,
Chronic obstructive pulmonary disease (COPD) is typically diagnosed and assessed through symptoms, lung function and a patient’s history. [1] These measures remain essential, but they cannot always explain why one patient deteriorates while another with apparently similar disease remains stable.
That matters because COPD remains a major unmet clinical need. The latest World Health Organization figures show that COPD caused 3.4 million deaths in 2023 – around 6% of all deaths worldwide – making it the third leading cause of death globally. [2] Diagnosing COPD is only part of the challenge; managing the disease after diagnosis is more complicated. Exacerbations – sudden periods in which symptoms worsen – can accelerate disease progression, lead to hospitalisation and have a major impact on quality of life.
One difficulty is that COPD is not biologically uniform, making exacerbations difficult to predict and manage. A flare-up may be linked to bacterial or viral infection, inflammation or environmental factors, and symptoms alone do not necessarily reveal what is driving it. Two patients with similar symptoms can therefore be experiencing very different changes in their lungs and may require different responses.
This is where biomarkers are becoming increasingly important.
A biomarker is, at its simplest, a measurable indicator of a biological process. In respiratory medicine, biomarkers can provide information that symptoms and conventional lung-function measurements cannot provide on their own: what type of inflammation is present, whether a patient may respond to a particular treatment or whether their condition is changing over time.
We are already seeing this approach influence COPD treatment. Certain blood tests, such as blood eosinophil counts, can identify patients with particular types of inflammation, helping researchers understand who may be more likely to respond to particular treatments1. This is the principle behind precision medicine: using a better understanding of an individual patient’s disease to identify the approach most likely to benefit them.
The implications for drug development are significant. Better biomarkers can help pharmaceutical companies identify the right patients for clinical trials, understand whether a medicine is having its intended effect and ultimately support the development of more effective, targeted therapies.
The next challenge is speed.
Most sophisticated biomarker analysis has historically taken place in central laboratories, but a result available days or weeks later may have limited value when the question is what is happening to a patient today.
A result available days or weeks later may have limited value when the question is what is happening to a patient today
There is already evidence that rapid testing can change decision-making. In the UK PACE randomised controlled trial, using a point-of-care C-reactive protein test during COPD exacerbations reduced antibiotic consumption compared with usual care without impairing patients’ COPD health status.[3] It demonstrates a simple principle: when clinicians have timely biological information alongside their clinical assessment, treatment can become more targeted.
This is why rapid point-of-care testing is attracting interest from researchers and the pharmaceutical industry. By allowing disease activity and treatment response to be tracked as a clinical trial progresses, it could make trials more efficient, accelerate drug development and ultimately get the right treatments to patients sooner.
One biomarker attracting particular interest in respiratory research is neutrophil elastase, an enzyme released by immune cells in response to inflammation and infection. Measuring its activity can offer clues about what is happening in the lungs.
Research in bronchiectasis, for example, has shown that active neutrophil elastase measured rapidly in sputum can identify patients with greater disease severity, airway infection and increased risk of future exacerbations. [4] Importantly, however, results in one respiratory disease cannot simply be assumed to translate to another. The relevant question is whether such biomarkers can provide similarly meaningful information in COPD.
That is the question behind a current 21-month collaboration between ProAxsis and Imperial College London, which is evaluating a rapid point-of-care test measuring active neutrophil elastase in people experiencing COPD exacerbations. The study is investigating its diagnostic value in a COPD population, with results expected in 2027. It is one example of a much wider movement towards bringing meaningful biological information closer to the point where decisions are made.
Beyond clinical trials, rapid testing could also make regular monitoring more practical, including the potential for more remote or community-based monitoring over time. This could allow changes in disease biology to be followed more closely, rather than relying only on isolated clinic visits or snapshots. For patients, the longer-term possibility is earlier recognition of meaningful changes, more personalised disease management and faster intervention when their condition begins to worsen or indeed before it worsens.
The real promise of biomarker-led respiratory medicine is not simply a faster test, but a transition from asking how severe a patient’s COPD appears to be, towards also understanding what is driving their disease at that particular point in time. That distinction could prove increasingly important in how we research, monitor and ultimately treat respiratory disease.
Pic: CNordic Nordic
References:
[2] World Health Organization (WHO) (2026) Chronic obstructive pulmonary disease (COPD)
- Dr Louise Ryan Murphy is Managing Director, ProAxsisÂ
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