for bladder cancer monitoring
Detect bladder cancer recurrences with a simple, non-invasive and accurate urine test

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THE NEED

Bladder cancer is the 5^th most common cancer in the western world, and 70%-80% of the patients are diagnosed with non-muscle invasive disease. There are estimated 400,000 to 800,000 active bladder cancer patients in the United States, as well as 1 to 2 million in Europe, who undergo local resection of the tumor and then have 1-4 follow-up visits each year due to the high recurrence rate of the disease. Follow-ups include cystoscopy procedures that are invasive and painful, are negative in 90% of cases, and detect only 70-80% of recurrences. Both cystoscopy and cytology are subjective, costly and highly dependent on the operator expertise. Therefore, there is a clear need for a non-invasive, robust and simple tool to follow-up non-muscle-invasive bladder cancer patients.

OUR SOLUTION

Bladder EpiCheck provides patients and clinicians with a simple, objective urine test to detect recurrence of bladder tumors. The test analyzes subtle disease-specific changes in DNA methylation markers, allowing for the detection of 86%¹ of the high-risk (non Ta-LG) cancers. High risk cancers² are important to catch as they are aggressive and most likely to progress to invasive cancer if not treated immediately. Bladder EpiCheck demonstrated Negative Predictive Value (NPV) of 99%¹ for high-risk cancer, meaning that when receiving a negative Bladder EpiCheck result, there is 99%¹ chance that no high-risk cancer is present. Bladder EpiCheck is an objective molecular test meaning that it does not rely on human interpretation. The result is a clear positive/negative for presence of bladder cancer, with an additional numerical results between 0-100.

Bladder EpiCheck can be used in a surveillance regimen to increase confidence in detection of recurrence and/or to reduce amount of cystoscopies.

Superior results - NPV 99%, sensitivity and specificity

Not affected by BCG, hematuria, infections

Simple urine test

HOW DOES IT WORK

DNA methylation biomarkers works as a set of “switches” that activate or deactivate specific genes to allow different cell types to fulfill their role. Therefore, it is an effective tool by which these cells can be distinguished. Cancer cells show changes in these biomarkers compared to healthy cells. These biomarkers can distinguish cancer cells from healthy cells, particularly for assessed cancer, from biological fluids such as urine and blood. This is exactly what the EpiCheck Bladder test does.

Unique methylation biomarker of EpiCheck

Biomarkers in bladder cancer

Methyl group (CH₃)

Biomarkers in healthy bladder cells

The EpiCheck Bladder test is based on 2 main technology platforms:

BIOCHEMISTRY:³

Analyzes DNA in urine and detects subtle DNA-specific methylation changes
Allows the detection of tumor DNA molecules in a mass of over 200,000 non-cancerous DNA molecules ⁵
Requires only small amounts of DNA
Simple laboratory analysis

BIOINFORMATICS:⁴

Identifies methylation biomarkers throughout the genome using an empirical approach
Builds an extremely informative biomarker panel
Yes / No Result + EpiScore (0-100)

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NPV

(exclusiv Ta-LG)

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SENSITIVITY

(exclusiv Ta-LG)

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SPECIFICITY

The results of studies conducted in urology centers in the Netherlands, Germany, Spain and Israel, compare EpiCheck Bladder with cystoscopy, cytology and anatomo-pathology for the detection of recurrence of non-musculoinvasive bladder cancer. Users and collaborators of the test include hospitals and urologists in the Netherlands, Austria, Germany, etc.

Advantages:

The test is performed on a regular urine sample and does not require an invasive procedure.
The test correlates the performance of cytology, cystoscopy and pathology.
The test has shown great accuracy in detecting high-grade cancer.

In selected cases, but not only, the test can even reduce follow-up cystoscopes due to the high negative predictive value.

References

^{1-Witjes et al. Eur Urol Oncol 2018;1(4):307-313}
^{2-Babjuk et al. https://uroweb.org/guideline/non-muscle-invasive-bladder-cancer/}
^{3-Frumkin et al. Forensic Sci Int Genet. (2011) 5(5):517-24}
^{4-Wasserstrom et al. Forensic Sci Int Genet. (2013) 7(1):136-42}
^{5-Frumkin et al. CNAPS 2019 Poster p-21S}