Clinical feasibility study and refinement of a rapid, point-of-care urinary test for detecting intravascular haemolysis
Lead supervisor: Professor Pawel Swietach
Co-supervisor: Dr Noemi Roy
Commercial partner: Camtech Innovations Ltd
DIAGNOSTIC NEED: Red blood cells (RBCs) survey every vascularised tissue in the body and become exposed to various mechanical, chemical, metabolic, infective and immunological stresses. With limited defences and repair capacity, RBCs may accumulate damage to the point of rupture (""intravascular haemolysis""). While haemolysis is clinically significant because consequences include anaemia, its diagnostic value lies in its potential as a sentinel of disease-related triggers relevant to ~300,000 people in UK and ~800 million globally. However, current tests require blood sampling, trained personnel and expensive assays, which preclude adoption for routine point-of-care diagnostics. Thus, there is an unmet need for cost-effective haemolysis tests that detect a suitable marker released into accessible fluids, such as urine.
OPPORTUNITY: Multiple factors can trigger haemolysis, making it a global concern and defining a market for millions of tests annually in the UK alone. A haemolytic event can occur as early as birth (blood group incompatibility) and remain a life-long concern (genetic trait), often in under-represented minorities. There is a clinical justification for frequent testing in patients with genetic (G6PD deficiency, inherited anaemias e.g., sickle-cell) or environment-related (Epstein-Barr, Dengue, malaria) risks.
OUR INNOVATION: We discovered a novel biomarker of haemolysis that is readily detectable in a small sample of urine. Working with CAMTECH Ltd, the licensee of our innovation, we developed a lateral flow device (LFD) that eliminates the need for blood-drawing, specialist equipment, and trained staff. The prototype addresses the limitations of gold-standard blood-based haemolysis tests that give delayed and indirect readouts (bilirubin), require calibration or baseline correction (haptoglobin), involve complex assays (LDH), detect a single cause (direct Coombs test), or lack specificity (blood haemoglobin). Our innovation can enable frequent monitoring, including self-testing at home. Adoption across clinical and community settings can empower patient autonomy and deliver cost-efficiencies to healthcare providers.
AIMS: To progress beyond TRL-5 and towards commercialisation, the next step is a feasibility study of our LFD prototype in a clinical setting to position the product. For this purpose, we selected sickle cell patients in the UK and malaria patients in Peru, cohorts with a strong propensity to haemolyse. Participants will be recruited for longitudinal LFD testing at home, clinic appointments and hospital admissions. Analytical performance will be benchmarked against laboratory-grade CA1 assays, and paired blood tests will relate LFD readout with haemolysis markers (LDH, bilirubin, reticulocyte count, Hb) to assess concordance and temporal relationship. Where necessary, we will refine device specifications according to feedback, define position in clinical pathways based on cost-effectiveness, and obtain evidence towards regulatory requirements.
BENEFITS: Rapid and routine haemolysis testing by LFD can flag a blood-related concern earlier to minimise complications, instigate timely lifestyle changes, or alarm for medical attention. LFD readouts can help refine choice and dosage of drugs among >100 agents known to trigger haemolysis. Since the timing of a haemolytic crisis is rarely predictable, self-testing can align hospital admission with clinical need, rapidly triage patients for further treatments, and encourage early discharge through continued monitoring. Resulting cost-efficiencies would motivate policymakers to recommend our technology.
Apply using course: DPhil in Physiology, Anatomy and Genetics
