Diagnostic classifier for risk stratification of haematuria patients (DCRSHP)

Abstract: In 2012, 5242 people in the UK lost their life to bladder cancer. The most common symptom of bladder cancer is blood in the urine (haematuria), which is usually painless. Haematuria can be frank (macroscopic), visible to the patient, or invisible (microscopic), which is normally detected during a routine urine dipstick test. Haematuria in its visible and invisible forms can represent a disease process within the urinary tract. Patients presenting with haematuria require investigations, including cystoscopy (endoscopy of the urinary baldder), cytology (which examines the appearance of cells in voided urine), and imaging of their urinary tracts, to identify the source of bleeding. Cystoscopy (the gold standard for bladder cancer detection) allows direct observation of the bladder, but is invasive and uncomfortable for the patient. If a suspicious region is observed a biopsy is needed. Cystoscopy does not allow for upper track visualisation, does not always detect small areas of carcinoma in situ, can give false positive results, is embarrassing for the patient and can be biased by the risk category of the patient. Cytology, has high specificity but poor sensitivity, and hence, cannot act alone for the diagnosis of urothelial cancer. Less than 20% of patients with macroscopic, and <5% with microscopic haematuria have bladder cancer. As such, it has been estimated that in the UK the total cost of managing patients with haematuria who are found not to have bladder cancer is >£33.5 million. Consequently, haematuria is a significant healthcare burden, which is only set to increase because of the aging population. Therefore, there is a strong clinical need for tests which can at least stratify haematuria patients and if possible, be diagnostic. Randox in collaboration with Queens University Belfast (QUB) and The Belfast Trust have identified a diagnostic classifier for risk stratification of haematuria patients (DCRSHP). The DCRSHP is a urine-based diagnostic test that is non-invasive, rapid, easy to use and interpret results, has high sensitivity and specificity, is unbiased, and allows high-throughput screening for hundreds of haematuria patient samples. Use of the DCRSHP at the GP surgery or the haematuria clinic will significantly reduce the number of 'low-risk' patients that are currently 'red flagged' for cystoscopy and improve waiting times for haematuria patients who do require diagnostic services i.e. those patients deemed at 'high risk'. The SBRI grant funding will allow us to engage with Health Economists/Diagnostic Evidence Cooperative to establish the validity and value of our test in a clinical setting.