DNA methylation test for Urothelial Carcinoma (UC) Early Detection
Intended for the auxiliary diagnosis of patients who have hematuria and/or bladder irritation, or are advised by doctors to undertake cystoscopy.
None-invasive urine test
Early Detection
Diagnosis
Therapy Selection
Therapy Monitoring
Introducing UriFind® Test
The UriFind® test is a non-invasive fluorescence quantitative PCR assay based on the detection of DNA methylation markers (ONECUT2 and VIM) present in urine-exfoliated cell samples. The test is suited for patients diagnosed with clinical hematuria or patients recommended for cystoscopy by a physician. It can provide physicians/patients with an auxiliary diagnosis option for urothelial carcinoma but cannot be solely used as a basis for tumor diagnosis. Clinicians should judge the diagnosis comprehensively based on the patient’s condition and other laboratory tests.
Accuracy at 89.3%, equivalent to the gold standard, cystoscopy
Sensitivity is 87.4% and specificity is 91.5%
Painless and convenient: Just 100ml of random urine needs to be collected for testing.
Professional recognition: verification and use experience of large clinical studies in hundreds of grade-A tertiary hospitals. The detection method and performance were published on professional medical journals The Journal of Clinical Investigation and Clinical Epigenetics
Urothelial Carcinoma (UC)
Disease Background
Urothelial carcinoma(UC) is cancer that begins in the urothelial cells, which line the urethra, bladder, ureters, renal pelvis, and some other organs. Almost all bladder cancers are urothelial carcinomas. In addition, UC also includes upper tract urothelia. The traditional technology has many limitations in the diagnosis of bladder cancer.
- High incidence of UC: Bladder cancer is the most prevalent tumor of the urinary system. The number of new cases is more than 80,000, and the number of deaths is more than 30,000.
- High mortality of UC: The MRI index of Men’s bladder cancer is 0.40 (mortality/incidence), which is higher than other tumors.
- High recurrence rate of UC: The 5-year recurrence rate of non-muscular invasive bladder cancer (NMIBC) is as high as 60-78%; the recurrence rate of upper urinary tract urothelial carcinoma (UTUC) is 22%-47%.
- High treatment cost of UC: The cost of treating bladder cancer by medical insurance ranks in the top 4 cancers.
- Traditional ultrasound imaging: Sensitivity 63-98%, dependence on physician experience, and inability to diagnose carcinoma in situ.
- Traditional urinary tumor marker: Low specificity and susceptibility to hematuria interference.
- Traditional urine cytology: Sensitivity 13-75%, difficulty detecting LG-UC, and inability to exclude diagnosis based on a negative result.
- Traditional fluorescence in situ hybridization (FISH): Low throughput, complex operation, and dependence on pathologist experience.
- Traditional cystoscopy + tissue biopsy: Liability to overlooking carcinoma in situ, invasive examination, and poor compliance of the patients of postoperative review.
With similar specificity and significantly higher sensitivity than urine cytology and FISH, UriFind® is a rapid, high-throughput, noninvasive, and promising approach for early diagnosis, minimal residual tumor detection, and surveillance in the whole course management of UC. Its implementation could reduce the burden of cystoscopy and unnecessary second TURBT.
What information does UriFind® result provide?
Positive Result
A positive UriFind result means that the methylation marker(s) were detected in the submitted specimen and that the patient is at High Risk of having urothelial carcinoma, or bladder cancer. The result should be reviewed by a physician and followed up by other diagnostic evaluations.
Negative Result
A negative UriFind result means that none of the markers was detected in the submitted specimen and that the patient is at Low Risk of having urothelial carcinoma. The result should be reviewed by a physician, and clinical evaluation and follow up are recommended.
Resources
References:
- Guidelines for Diagnosis and Treatment of Bladder Cancer (2018). GWBYH [2018] 1125.
- China Statistical Yearbook of Health and Family Planning (2020).
- J Clin Invest. 2020 Dec 1;130(12):6278-6289.
- Clin Epigenetics. 2021 Apr 26;13(1):91.