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A urine test from the Israeli company Nucleix that reads fifteen DNA methylation markers and gives a score for bladder cancer recurrence, aimed at sparing patients under surveillance some of their camera examinations.
What it measures. Bladder EpiCheck extracts DNA from a voided urine sample and measures methylation at fifteen marker sites that are methylated in bladder cancer and not in normal urothelium, combining them into an EpiScore from 0 to 100 with a fixed cut-off. It is read by real-time PCR after methylation-sensitive digestion, so it needs a PCR laboratory rather than a sequencer.
Who should have it. The validated use is surveillance of non-muscle-invasive bladder cancer after resection, where the aim is to detect recurrence between scheduled cystoscopies and, in patients with a negative result, to extend the interval. The published performance is a high negative predictive value for high-grade recurrence, with the misses concentrated in low-grade tumours that carry little risk. It is also being studied for upper tract urothelial cancer and for the work-up of blood in the urine.
Regulatory status, cost and availability. Bladder EpiCheck is CE marked in Europe and is offered through Nucleix and partner laboratories; it is not an approved primary test in place of cystoscopy anywhere. Cost is that of a molecular urine test, higher than cytology, lower than a sequencing panel.
What changes. A positive score sends the patient to cystoscopy and imaging sooner; a negative score, in guidelines that permit it, lets the urologist lengthen the surveillance interval. The randomised evidence that this is safe is still being gathered, which is why guidelines describe such tests as complementary to cystoscopy rather than replacements.
Methylation-sensitive restriction digestion of urinary DNA followed by real-time PCR on fifteen bladder-cancer-specific methylation markers, combined into an EpiScore with a fixed positive cut-off.
Query for this technology: (TITLE:"Bladder EpiCheck urine methylation test" OR ABSTRACT:"Bladder EpiCheck urine methylation test" OR TITLE:"EpiCheck" OR ABSTRACT:"EpiCheck" OR TITLE:"urine methylation test for bladder cancer" OR ABSTRACT:"urine methylation test for bladder cancer") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Bladder EpiCheck urine methylation test, not a curated reading list.
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