AssureMDx For Bladder Cancer Detection

Test Introduction

AssureMDx is a noninvasive, urine-based test which evaluates genomic changes associated with the presence of bladder cancer and can help identify high-risk patients who will benefit from clinical evaluation by a urologist. Importantly, the test also helps identify low-risk patients who may safely avoid invasive and potentially harmful diagnostic procedures.

For more information about ordering this test, visit: Vesica Health

Test Description

How AssureMDx™ Works

AssureMDx is a proprietary multi-omic test that interrogates the DNA methylation status of OTX1, ONECUT2 and TWIST1 genes in combination with the somatic mutation status of FGFR3, TERT and HRAS genes for the detection of bladder cancer signal in a urine sample.

AssureMDx combines the power of these DNA biomarkers with the addition of clinical risk factors to determine a patient’s risk of having bladder cancer detected upon cystoscopy.

References:

1) van Kessel et al, J Uro 2016, 2) van Kessel et al J Uro 2017, 3) de Jong et al, J Uro 2020

Test Summary:

Clinically Validated Performance

AssureMDx genes & technology have been validated and reported in:

22 peer-reviewed, published studies
>6,000 patients
0.96 Area Under Curve
96% Sensitivity
99% Negative Predictive Value

Year	Authors	Journal	Subjects
2024	de Jong et al	European Urology Open	143
2023	de Jong et al	European Urology Oncology	Review
2020	van Kessel et al	Journal of Urology	838
2017	van Kessel et al	Journal of Urology	200
2017	Beukers et al	Journal of Urology	977
2016	van Kessel et al	Journal of Urology	154
2014	Allory et al	European Urology	468
2013	Yegin et al	DNA & Cell Biology	71
2013	Beukers et al	PLOS One	169
2013	Zuiverloon et al	Journal of Urology	136
2013	van Kessel et al	Journal of Urology	70
2013	Kandimalla et al	Clinical Cancer Research	445
2013	Bangma et al	European Urology	409
2012	Kamidalla et al	European Urology	274
2011	Zuiverloon et al	Journal of Urology	18
2011	Zuiverloon et al	BJU International	112
2010	Zuiverloon et al	Clinical Cancer Research	200
2010	Kompier et al	PLOS One	257
2010	van der Aa et al	Journal of Urology	448
2010	Renard et al	European Urology	466
2005	van Oers et al	Clinical Cancer Research	92
2003	van Rhijn et al	Clinical Cancer Research	74

Test Ordering

AssureMDx is available for purchase directly through the Vesica Health website. This test was developed, and its analytical performance characteristics have been determined by Vesica Health. The test is performed in the Vesica Health Clinical Laboratory located in the ResearchDx Incubator Facility. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Sample Collection and Shipping Instructions

AssureMDx is available for purchase directly through the Vesica Health website. The test kit contains all required materials for urine collection and shipping the kit to Vesica Health Laboratory for analysis.

Order Your Test Today