URODIAG


Accurate and sensitive urine test for early diagnosis and the surveillance of low, intermediate and high-risk non-muscle-invasive bladder cancer

 

To better select patients for diagnostic cystoscopy





Non-invasive urine test


Aid in the decision for cystoscopy

Very high accuracy

Better than urine cytology

User-friendly

Fast processing

Cost-effective

 

 



 Clinical performance




Sensitivity: URODIAG has a very high ability to correctly identify patients with bladder cancer

NPV: URODIAG negative predictive value means close 100% probability of being a true negative and represent the absence of bladder cancer

 

Technology

- 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


Patent

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)




Publication

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
November 2017 : CE Mark for URODIAG by autocertification
September 2018 : Angels Santé, BAdGE & Normandie Business Angels invested in OncoDiag