Bladder EpiCheck® bladder cancer test

An innovative, non-invasive urinary biomarker test designed to assess the risk of bladder cancer recurrence. The test features high sensitivity, a strong negative predictive value, and may help reduce the need for invasive cystoscopies.

More effective follow-up for patients with bladder cancer

Bladder cancer is the fifth most common cancer in the Western world and one of the most expensive due to long-term surveillance. Because recurrences are frequent, patients may undergo up to four cystoscopies per year – an invasive and uncomfortable procedure.

Bladder EpiCheck® offers an advanced alternative: a high-sensitivity, high–negative predictive value non-invasive test that can reduce the need for cystoscopies while maintaining diagnostic accuracy and patient safety.

How does the Bladder EpiCheck® test work?

Bladder EpiCheck® is an advanced urinary biomarker test that non-invasively evaluates the risk of bladder cancer recurrence. It analyses specific epigenetic DNA changes (methylation patterns) characteristic of tumour-related cellular changes and is defined by high sensitivity and a high negative predictive value.

91% sensitivity in high-risk NMIBC cases

99% negative predictive value

85% specificity

Designed for surveillance of low- and intermediate-risk NMIBC

Detects epigenetic tumour markers in urine

Helps identify patients for whom cystoscopy may not be necessary

Less invasiveness, more accuracy in patient surveillance

Bladder EpiCheck® enables reliable monitoring of bladder cancer without unnecessary cystoscopies. This is especially important for patients at risk of recurrence, where not every cystoscopy is justified. The test helps optimise the diagnostic pathway, reduces patient discomfort, and improves healthcare efficiency.

Reduced need for cystoscopies

The test makes it possible to responsibly postpone or replace some cystoscopies in low- and intermediate-risk cases.

High reliability

With 91% sensitivity and a 99% negative predictive value, the test can confidently rule out the likelihood of recurrence.

Non-invasive method

Performed on a urine sample – patients do not need to undergo an unpleasant invasive procedure.

Aligned with the latest clinical recommendations

Included in the 2022 European Association of Urology (EAU) guidelines as a recommended tool for NMIBC surveillance.

When and for whom is the test recommended?

For patients with non–muscle-invasive bladder cancer (NMIBC)

Particularly suitable for follow-up of low- or intermediate-risk NMIBC patients when there is no clear need to frequently repeat invasive procedures.

For those who want to reduce the number of cystoscopies

If a patient experiences discomfort or anxiety related to regular cystoscopies, Bladder EpiCheck® may help avoid or delay them while maintaining diagnostic accuracy.

For those seeking a reliable, non-invasive surveillance alternative

The test helps identify recurrence risk early and, with a negative result, reliably rules out disease recurrence.

In line with clinical guidelines

Bladder EpiCheck® is included in EAU guidance as a recommended method for monitoring low- and intermediate-risk patients.

Bladder EpiCheck® reliability: accuracy and quality metrics

Bladder EpiCheck® uses advanced epigenetic profiling technology to reliably detect tumour-related changes in urine. Clinical studies have demonstrated very high accuracy, supporting evidence-based decisions on further surveillance.

91% sensitivity in high-risk cases

99% negative predictive value

85% specificity

Non-invasive assessment of bladder cancer recurrence risk

Take the Bladder EpiCheck® test and support patient safety and comfort.

For Specialists

All key information in one place – from biomarkers analysed to accuracy and clinical value. This section is intended for specialists who want a detailed understanding of the test rationale, structure, and practical applications.

Inclusion in clinical guidelines (EAU, 2022)

Bladder EpiCheck® is included in the 2022 European Association of Urology (EAU) clinical guidelines for non–muscle-invasive bladder cancer (NMIBC). It is recommended for surveillance of low- and intermediate-risk patients as an alternative or complementary method to cystoscopy. The EAU highlights the test’s high sensitivity and negative predictive value.

Clinical accuracy and reliability

A meta-analysis published in European Urology Oncology reported that Bladder EpiCheck® shows:

- 91% sensitivity in high-risk NMIBC cases
- 99% negative predictive value
- 85% specificity

These were the best performance metrics among the urinary biomarker tests evaluated.

Epigenetic technology

The test is based on analysis of specific methylation patterns – epigenetic changes commonly found in malignant cells. It is performed on a urine sample without invasive instruments, reducing the risk of infection, complications, and patient discomfort.

Indications and use cases

Bladder EpiCheck® is recommended for low- and intermediate-risk NMIBC patients. It can be used as a substitute or as a triage (“filter”) test before a planned cystoscopy to rule out recurrence risk. A negative result indicates a very low probability of tumour presence, allowing invasive surveillance to be safely deferred.

Economic benefit for the healthcare system

The test can reduce the number of cystoscopies, decrease pressure on outpatient urology services, and conserve resources. According to Prof. Fred Witjes (chair of an EAU committee), it is a cost-effective solution that improves patient care.