The UK DRI Biomarker Factory aims to transform the early detection, diagnosis and monitoring of dementia, by facilitating the development of fluid biomarkers for research and the clinic. This includes biological signals found in the blood, paving the way for scalable, non-invasive diagnostic tests.
Transforming the early detection, diagnosis and monitoring of dementia
Why is the early diagnosis of dementia so important?
We know that for the majority of neurodegenerative conditions, harmful changes to the brain begin decades before symptoms appear. To stand a better chance of slowing or stopping disease progression, we need to intervene with treatments at the earliest stages.
At present, it is very difficult and costly to diagnose and differentiate these diseases. Currently, only 2% of people with dementia symptoms receive a specialist test to confirm the underlying disease, e.g. Alzheimer’s disease. This is partly because existing diagnostic methods are expensive and resource-intensive for healthcare services to provide (PET scanning) and may also be invasive for the patient (lumbar puncture for cerebrospinal fluid (CSF) testing). A defined set of accurate, low-cost and scalable tests would revolutionise clinical practice and support the development of new therapies in the following ways:
- Detection – An early diagnosis gives patients more time for decision making and the best chance of being eligible for disease-modifying treatments. It may also qualify them to participate in clinical trials. Currently, inaccurate recruitment for trials significantly compromises the assessment of new therapeutics in development.
- Differentiation – Dementia can be caused by a number of diseases which, while having some overlapping symptoms, are likely to have different causes and drivers. Being able to pinpoint the exact condition will help target the right treatments to the right individuals.
- Monitoring – Most neurodegenerative disorders progress over many years, with new symptoms presenting as further brain regions are damaged. Being able to track disease over time offers huge benefits including the ability to monitor the impact of new treatments in clinical trials, which may only become apparent over a prolonged period.
What are biomarkers?
Short for ‘biological markers’, biomarkers are a measure – or a flag – of a biological state, helping us identify and monitor healthy biological processes or, crucially, harmful changes occurring in disease.
Biomarkers come in many different forms, including:
- Brain imaging is the most commonly used measure to detect changes to the brain such as a a build-up of disease proteins and loss of tissue.
- Digital biomarkers are an exciting new research area, with teams like the UK DRI’s Care Research & Technology Centre, aiming to measure subtle changes in sleep, movement, behaviour and more to detect and monitor neurodegenerative disease.
- Functional biomarkers identify changes in how our body works to help reveal fundamental biological mechanisms, and potential causes of disease. The UK DRI is investing in this area with initiatives such as a Grand Challenge to measure abnormalities in the function of brain circuitry to diagnose the earliest stages of Alzheimer’s.
- Fluid biomarkers such as molecules and proteins found in the blood or CSF which bathes the brain, are of high interest with some already harnessed for clinical trial assessment. The team at the UK DRI Biomarker Factory are supporting the development of new fluid biomarker tests that could one day lead to a simple blood test for a range of neurodegenerative conditions.
What is the Biomarker Factory?
The Biomarker Factory was established by UK DRI Group Leader and world-leading biomarker expert Prof Henrik Zetterberg in Spring 2021, following a £1M investment from the UK DRI. The unique facility is located at the UK DRI’s Hub at UCL, led by Senior Research Fellow Dr Amanda Heslegrave.
Its goal is to support the measurement, development and validation of fluid biomarkers in neurodegenerative projects taking place across the world. Using state-of-the-art, ultrasensitive instruments, the expert team of UK DRI technical staff have the capacity to handle thousands of samples from human and animal studies, performing a range of measurements on blood (plasma/serum) and CSF.
Their work has already led to several high impact studies pushing new frontiers in the field of diagnostics and disease monitoring. Ultimately, they hope to develop an accurate, low-cost and scalable blood test to diagnose a range of neurodegenerative disorders in the clinic.
Equipment capabilities
The Biomarker Factory’s current infrastructure includes:
- Quanterix Simoa HD-X technology, that provides a fully automated ultrasensitive biomarker measurement with up to 1000x greater sensitivity than traditional immunoassays. The lab has a team of technical experts and four Simoa HD-X instruments that provide the capacity to support fluid biomarker measurement of small, medium, and large scale (2000+ samples) projects.
- The laboratory will deploy Alamar NULISA technology after further validation – see more details below.
- The laboratory also has other technologies that can be used for a specific biomarker project such as ultrasensitive Single Molecule Counting (SMCxPRO) from Merck and Meso Scale Discovery instruments from MSD, as well as Luminex technology and regular ELISA platforms.
Biomarker portfolio
Popular assays that the Biomarker Factory currently performs include:
- Alzheimer’s disease-related – AB40/42, total tau, pTau181, pTau217
- Glial activation markers - GFAP, sTREM2
- Neurodegeneration – NfL
- Inflammation – Olink panels, MSD panels
Accessing the Biomarker Factory
The Biomarker Factory welcomes new academic collaborations and industry partners interested in leveraging the latest in biomarker technology for their studies.
Compared to other services in this area, the platform is offered at an extremely competitive rate, in addition to the benefit of extensive knowledge and expertise from the team who can advise on optimal study design, biomarker selection, sample collection and storage, data interpretation and more.
The Biomarker Factory accepts CSF, plasma and serum samples from animal and human studies. The facility operates as a research lab and therefore does not hold normal control values or give out results intended to be diagnostic.
For researchers, industry and commercial partners wishing to access the Biomarker Factory, or to ask any questions you may have, please email ukdri.biomarker.enquiries@ucl.ac.uk.
