Ultra-sensitive urine-based test for the surveillance of low, intermediate and high-risk non-muscle-invasive bladder cancer (NMIBC)

Non-invasive test

High accuracy

 Reduces follow-up cystoscopies

 Replaces urine cytology

Fast processing



Sensitivity: URODIAG has a very high ability to correctly identify patients with bladder cancer
Specificity: URODIAG has a very high ability to correctly identify patients without bladder cancer
NPV: URODIAG negative predictive value means close 100% probability of being a true negative and represent the absence of bladder cancer



- An integrated genetic and epigenetic analysis

- A sensitive and highly specific multiplex quantitative real-time PCR

- Urotest detects 4 mutations of the FGFR3 gene (S249C, R248C, G372C, Y375C) and measures the level of DNA methylation of HS3ST2, SEPTIN9 and SLIT2 genes

URODIAG uses its own diagnostic algorithm that identifies the presence or absence of the bladder cancer


EP 13306580, 2013: Methods for the surveillance, diagnosis and screening of bladder cancer. November 18, 2014: International extension extension PCT/EP2014/074892. May 19, 2016: Entering national phase (EU, US, CA, AU, JP)


Roperch JP and Hennion C. A novel ultra-sensitive method for the detection of FGFR3 mutations in urine of bladder cancer patients - Design of the Urodiag PCR kit for surveillance of patients with non-muscle-invasive bladder cancer (NMIBC). BMC Medical Genetics. 2020 May 24;21(1)112.

Roperch JP, et al; Promoter hypermethylation of HS3ST2, SEPTIN9 and SLIT2 combined with FGFR3 mutations as a sensitive/specific urinary assay for diagnosis and surveillance in patients with low or high-risk non-muscle-invasive bladder cancer. BMC Cancer. 2016 Sep 1;16:704.




News & events
2020: OncoDiag presented the Urodiag test at the 17th Meeting of the European Section of  Oncological Urology (ESOU20), 17-19 January 2020 - Dublin, Ireland
2018: Angels Santé, BAdGE & Normandie Business Angels invested in OncoDiag
2017: CE Mark for URODIAG by autocertification