Advice

The technology

The technology

URO17 is a urine test for detecting bladder cancer in people with symptoms associated with malignancy, including blood in the urine (haematuria) or lower urinary tract symptoms. It is also indicated for detecting urogenital cancer recurrence in the urogenital tract during treatment follow up.

URO17 is an immunocytochemistry-based test that detects the presence of the oncoprotein keratin 17 (K17), which is a member of cytokeratin family of proteins. There is evidence suggesting that K17 is associated with poor prognosis in tumorigenesis of malignancies such as cervical, endometrial and lung. Studies also found that K17 is expressed in urothelial cancer and suggested that K17 is a highly accurate biomarker for underlying biopsy-confirmed urothelial cancer (Babu et al. 2018; Babu et al. 2020).

The company notes that the diagnostic utility of URO17 in people who have had Bacillus Calmette-Guerin (BCG) or radical radiotherapy is not conclusive. There is an ongoing study in this patient group.

Innovations

URO17 is an in-vitro diagnostic test based on a novel biomarker for bladder cancer. The company notes that, unlike other urine-based tests, the URO17 assay can test people with visible or invisible haematuria. This means that people with early-stage cancers could be identified as early as possible.

It is a non-invasive test. Currently dipstick tests check the urine for traces of blood. People with a positive result are referred on for invasive procedures such as cystoscopy to get a definitive diagnosis. URO17 could help rule out cancer, or flag it up, at the first stage, reducing unnecessary invasive procedures and hospital visits.

Current care pathway

Diagnosis

Bladder cancer is usually identified from blood visible in the urine or found during urine testing. Emergency admission is also a common way for bladder cancer to present, and is often associated with a poor prognosis. The prevalence of the condition and the nature of its management make bladder cancer one of the most expensive cancers for the NHS.

Cystoscopy is the standard investigation for suspected bladder cancer and for treatment follow up. Urinary biomarkers are only recommended in the context of a clinical research study.

If abnormalities are found during cystoscopy, white-light-guided transurethral resection of bladder tumour (TURBT) is recommended. If muscle-invasive bladder cancer is suspected at cystoscopy, CT or MRI staging should be considered before TURBT. TURBT should be done or supervised by a urologist experienced in the procedure. It should be done with:

  • photodynamic diagnosis

  • narrow band imaging

  • cytology or

  • a urinary biomarker test (such as UroVysion using fluorescence in-situ hybridisation, ImmunoCyt or a nuclear matrix protein 22 test).

Random biopsies of normal-looking urothelium during TURBT should not be taken unless there is a specific clinical indication (for example, to investigate positive cytology that is not otherwise explained). The size and number of tumours found during TURBT should be recorded.

Monitoring after treatment

Periodic cystoscopy should be offered to patients after treatment for non-muscle-invasive bladder cancer and after radical radiotherapy for muscle-invasive bladder cancer. The frequency depends on the severity and risk of bladder cancer.

Urinary biomarkers and cytology can be offered with cystoscopy for all patients except those with low-risk bladder cancer. If someone's muscle-invasive bladder cancer has been treated with radical cystectomy or radical radiotherapy, they should also be offered annual upper-tract imaging and CT of the abdomen, pelvis and chest. This should be 6 months, 12 months and 24 months after treatment to monitor for local and distant recurrence. Anyone with haematuria or other urinary symptoms and a history of non-muscle-invasive bladder cancer should be urgently referred to urological services.

The following publications have been identified as relevant to this care pathway:

Population, setting and intended user

URO17 is intended to be used as a diagnostic tool to help identify people with haematuria or lower urinary tract symptoms with a suspicion of bladder cancer. It is also intended for monitoring recurrence in the urogenital tract during treatment follow up.

The company proposition originated from a UK urologist saying that 85% of haematuria cases identified in primary care are not malignant when investigated in secondary care. Also that there are currently long waiting lists for urology assessment because of COVID‑19 restrictions. URO17 could be used to stratify patients on waiting lists to prioritise cases, as well as avoiding potentially unnecessary hospital visits for other patients during the COVID‑19 pandemic.

Costs

Technology costs

The cost of the URO17 test is £110 per test (excluding VAT).

Costs of standard care

Costs per test (excluding VAT) are:

Resource consequences

The cost of investigating haematuria is significant, in large part because of the cost of the cystoscopy. In the UK investigating people with haematuria who do not have bladder cancer was estimated in 2008 at £100 million, a third of the total cost of managing non-muscle-invasive bladder cancer (Abogunrin et al. 2011). This could be offset with a low-cost diagnostic test. Causes of haematuria and risk of bladder cancer vary. Investigations can reveal no identifiable cause, infection, benign causes or urological cancers.

URO17 is being introduced into the NHS but is not yet widely used. The test has the potential to be resource releasing if using it results in earlier diagnosis and treatment because of more accurate detection of bladder cancer. However, false-positive results could have cost and resource consequences by leading to further testing. Using the test to monitor patients during follow up may lead to an initial increase in resource use in this setting. Minimal to no training is needed, and no changes to facilities or infrastructure are needed to adopt the technology because urinalysis is already used routinely.