Clinical Areas

At the NIHR Leeds In Vitro Diagnostics Co-operative we focus on the evaluation of IVDs within four areas of clinical expertise. These are:

Musculoskeletal diseases

Theme leads: Prof. Paul Emery

Musculoskeletal (MSK) diseases, such as rheumatoid arthritis (RA) and scleroderma are devastating chronic diseases, which if treated sub-optimally cause severe joint damage, reduced life expectancy and poor general health. Clinical decision making is confounded by variability between individuals in response to treatment and adverse reactions.

No single agent achieves a satisfactory outcome for all patients. Newer drugs are more effective, but come at a high cost. There is a need to improve therapy using a targeted approach. IVDs to detect protein or genetic biomarkers may allow delivery of personalised medicine and improve monitoring for complications, such as lung fibrosis and cardiovascular disease.

In Leeds, we have a large translational musculoskeletal research programme with extensive biobanks and intensely phenotyped RA and other disease cohorts including populations at risk. Samples and data from these studies will support the NIHR Leeds MIC research programmes and enable evaluation of candidate Musculoskeletal disease biomarkers.


Theme lead: Prof. Gordon Cook

Our strategy is to use IVDs to design more targeted treatment pathways and guide treatment decisions.

Our focus will be on B-cell malignancies such as myeloma and lymphoma, as well as colorectal, renal and prostate cancers. The variable prognosis for patients with B-cell malignancies in particular offer a huge opportunity for more personalised treatment. NIHR Leeds MIC researchers are ideally placed to support the development of IVDs which can identify relevant patient subgroups.

We recognise the urgent need for new biomarkers to predict response to new immunotherapy treatments. Through NIHR Leeds MIC we will work with commercial partners to evaluate new predictive biomarkers for colorectal, renal and prostate cancers. For example, NIHR Leeds MIC already has a successful collaboration with a Spanish company, Biomedica, to clinically validate its tissue-based biomarker for renal cancer.

Renal Medicine

Theme lead: Dr. Andrew Lewington

The NIHR Leeds MIC Renal Medicine Theme includes acute kidney injury (AKI), chronic kidney disease (CKD) and kidney Transplantation.

Acute kidney injury (AKI) is a syndrome with many different causes. In the majority of cases it is secondary to sepsis, toxins or low blood pressure in acutely ill patients. It is a common condition occurring in up to 18 percent of hospital patients and is associated with worse outcomes including increased hospital length of stay, mortality and the development of CKD in 40% of AKI survivors. The annual cost of AKI to the NHS in England has been estimated at £1.02 Billion. There has been relatively little progress in improving patient outcomes and an urgent need to improve diagnostics and therapeutic interventions.

Chronic kidney disease (CKD) occurs is 10 % of the world’s population. CKD is associated with increased cardiovascular risk and can progress to end stage kidney disease (ESKD), requiring dialysis or kidney transplantation. CKD in the UK is estimated to cost £1.45 billion per year. Current therapies are limited in clinical practice by a failure to better understand the underlying pathophysiology. Biomarker-based in-vitro diagnostics (IVDs) are urgently needed to improve earlier identification and stratification of patients with progressive CKD to drive on the development of new therapeutic strategies.

Kidney transplantation is the treatment of choice for patients who have developed ESKD following AKI or progressive CKD. There is a chronic shortage of donor kidneys and patients awaiting kidney transplantation have an increased risk of death. Throughout the lifetime of a kidney transplant there is a need to monitor the function closely. The current in-vitro diagnostics are limited in their scope to differentiate the different causes of acute kidney transplant injury or identify patients at risk of progressive chronic kidney transplant disease. There is a need to develop new IVDs to guide and optimise the management of patients with kidney transplants.

Infection diagnostics

Theme lead: Prof. Mark Wilcox

Our new Infection Diagnostics theme already has evidence of high quality interactions with industry partners and excellence in the team in our existing portfolio.

Our research is linked to the interests and priorities of the Healthcare Associated Infection Research Group, including infection diagnosis and management, infection control and antimicrobial resistance and operates a shared goal of excellence across academia, patient care and public health.

We aim to build on our track record of translational research to produce infection diagnostics research that directly informs the clinical use of both established and novel IVDs. We also aim to support clinical trials with high quality infection diagnostics; to partner with internal and external researchers to develop novel infection diagnostics; and to produce guidance for the NHS on infection diagnostics.